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Azar L, Tey K. Endoscopic Retrieval of a Migrated Intragastric Balloon Causing Small Bowel Obstruction: A Case Report and Review of Management Strategies. Cureus 2025; 17:e81808. [PMID: 40337570 PMCID: PMC12056879 DOI: 10.7759/cureus.81808] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/05/2025] [Indexed: 05/09/2025] Open
Abstract
Intragastric balloons (IGBs) are widely used as a temporary weight-loss measure to induce early satiety and delay gastric emptying. Despite their safety profile, rare complications such as migration and small bowel obstruction (SBO) may occur, particularly when follow-up for timely removal is neglected. We present a case of a 48-year-old female with a history of obesity who arrived at the emergency department complaining of abdominal pain, nausea, vomiting, and obstipation of three days duration. Imaging revealed a dilated stomach and duodenum, with a fluid-filled IGB lodged in the proximal jejunum, causing SBO. Push enteroscopy was performed using a colonoscope, and the IGB was retrieved successfully from the jejunum into the stomach and removed entirely, avoiding the need for surgery. The patient recovered without complications and was discharged the following day. This case demonstrates an innovative approach to managing SBO caused by IGB migration. While surgery is typically the preferred method for small bowel impaction, endoscopic retrieval presents a viable, less invasive option. This article highlights the importance of gastroenterology consultation in managing migrated IGBs and reviews different techniques for endoscopic retrieval. We conclude that endoscopic management of migrated IGB causing SBO should be considered a first-line approach to minimize complications and shorten hospital stays, provided a backup surgical team is available.
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Affiliation(s)
- Loai Azar
- Internal Medicine, Banner - University Medical Center Tucson, Tucson, USA
| | - Kai Tey
- Gastroenterology and Hepatology, University of Arizona College of Medicine - Tucson, Tucson, USA
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Matteo MV, Bove V, Pontecorvi V, Gualtieri L, Carlino G, Spada C, Boškoski I. The evolution and current state of bariatric endoscopy in Western countries. Clin Endosc 2024; 57:711-724. [PMID: 38919056 PMCID: PMC11637666 DOI: 10.5946/ce.2023.253] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/29/2023] [Revised: 01/11/2024] [Accepted: 01/14/2024] [Indexed: 06/27/2024] Open
Abstract
With the alarmingly increasing prevalence of obesity in the Western world, it has become necessary to provide more acceptable treatment options for patients with obesity. Minimally invasive endoscopic techniques are continuously evolving. Currently, metabolic and bariatric endoscopies encompass several different techniques that can offer significant weight loss and improvement in comorbidities with a favorable safety profile. Restrictive bariatric procedures include the use of intragastric balloons and gastric remodeling techniques with different suturing devices. Several studies have demonstrated the efficacy and safety of these techniques that are widely used in clinical practice. Small intestine-targeted metabolic endoscopy is an intriguing and rapidly evolving field of research, although it is not widespread in routine practice. These techniques include duodenal-jejunal bypass liners, duodenal mucosal resurfacing, and incisionless anastomoses. The aim of this review article is to provide a detailed update on the currently available bariatric endoscopy techniques in Western countries.
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Affiliation(s)
- Maria Valeria Matteo
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Università Cattolica del Sacro Cuore, Roma, Italy
| | - Vincenzo Bove
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Università Cattolica del Sacro Cuore, Roma, Italy
| | - Valerio Pontecorvi
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Università Cattolica del Sacro Cuore, Roma, Italy
| | - Loredana Gualtieri
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Sapienza University of Rome, Rome, Italy
| | - Giorgio Carlino
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Università Cattolica del Sacro Cuore, Roma, Italy
| | - Cristiano Spada
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Università Cattolica del Sacro Cuore, Roma, Italy
| | - Ivo Boškoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
- Università Cattolica del Sacro Cuore, Roma, Italy
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de Moura DTH, Sánchez-Luna SA, Silva AF, Bestetti AM. Intragastric Balloons: Practical Considerations. Gastrointest Endosc Clin N Am 2024; 34:687-714. [PMID: 39277299 DOI: 10.1016/j.giec.2024.04.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/17/2024]
Abstract
Obesity is escalating, projected to affect 17.5% of adults globally and afflict 400 million children by 2035. Managing this intricate and chronic condition demands personalized, multidisciplinary approaches. While dietary changes, lifestyle modifications, and medications yield short-term results, long-term outcomes are often poor, with bariatric surgery standing out as the most effective option. However, only a small fraction undergoes surgery due to various barriers. Intragastric balloon (IGB) emerges as a minimally invasive alternative, approved by major regulatory bodies. This review adresses the pivotal role of IGB in obesity management, delving into its history and technological evolution.
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Affiliation(s)
- D T H de Moura
- Gastrointestinal Endoscopy Division, Instituto D´Or de Pesquisa e Ensino (IDOR), Hospital Vila Nova Star, R. Dr. Alceu de Campos Rodrigues, 126 - Vila Nova Conceição, São Paulo, São Paulo 04544-000, Brazil; Gastrointestinal Endoscopy Unit, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 Cerqueira César, 05403-000, Brazil.
| | - Sergio A Sánchez-Luna
- Division of Gastroenterology & Hepatology, Department of Internal Medicine, Basil I. Hirschowitz Endoscopic Center of Excellence, The University of Alabama at Birmingham Heersink School of Medicine, 510 20th Street S, LHFOT 1203, Birmingham, AL 35294, USA
| | - Adriana Fernandes Silva
- Gastrointestinal Endoscopy Unit, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 Cerqueira César, 05403-000, Brazil
| | - Alexandre Moraes Bestetti
- Gastrointestinal Endoscopy Division, Instituto D´Or de Pesquisa e Ensino (IDOR), Hospital Vila Nova Star, R. Dr. Alceu de Campos Rodrigues, 126 - Vila Nova Conceição, São Paulo, São Paulo 04544-000, Brazil; Gastrointestinal Endoscopy Unit, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 Cerqueira César, 05403-000, Brazil
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Ameen S, Merchant HA. Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs. Expert Rev Med Devices 2024; 21:37-54. [PMID: 38030993 DOI: 10.1080/17434440.2023.2289691] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2023] [Accepted: 11/27/2023] [Indexed: 12/01/2023]
Abstract
INTRODUCTION Sustaining a healthy weight is a challenge and obesity, with associated risk of co-morbidities, is a major public health concern. Bariatric surgery has shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs). AREAS COVERED This review critically appraises IGBs used in the past, present, and those in clinical trials, discussing the device designs, limitations, placement and removal techniques, patient eligibility, efficacy, and safety issues. EXPERT OPINION Several intragastric balloons were developed over the years that brought excitement to patients and healthcare professionals alike. Albeit good efficacy, there had been several safety issues reported with IGBs such as spontaneous deflation, intestinal occlusion, gut perforation, and mucosal ulcerations. This led to evolution of IGBs design; device material, filling mechanism, fluid type, inflation volume, and further innovations to ease ingestion and removal of device. There are some IGB devices under development aimed to swallow like a conventional pill and excrete naturally through defecation, however, how successful they will be in clinical practice in terms of their efficacy and tolerability remains to be seen in the future.
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Affiliation(s)
- Sara Ameen
- Department of Pharmacy, School of Applied Sciences, University of Huddersfield, West Yorkshire, UK
| | - Hamid A Merchant
- Department of Pharmacy, School of Applied Sciences, University of Huddersfield, West Yorkshire, UK
- Department of Bioscience, School of Health, Sport and Bioscience, University of East London, London, UK
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Mathur W, Kosta S, Reddy M, Neto MG, Bhandari M. Effect of Swallow Balloon Therapy with the Combination of Semaglutide Oral Formulation: a Randomised Double-Blind Single-Centre Study. Obes Surg 2024; 34:198-205. [PMID: 38091192 DOI: 10.1007/s11695-023-06975-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2023] [Revised: 11/15/2023] [Accepted: 11/26/2023] [Indexed: 01/11/2024]
Abstract
BACKGROUND Obesity is a significant public health issue; new therapies and pharmaceutical approaches to weight management are needed. OBJECTIVE This study assesses weight reduction efficacy in the novel swallow balloon procedure and semaglutide, both promising non-surgical and pharmaceutical options, addressing obesity's critical public health challenge. METHODS This was a computer-generated, blocked randomisation, double-blind, single-centre study. Fifty-seven participants were assigned to swallow balloon therapy group I (with semaglutide), and 58 were assigned to swallow balloon therapy group II (without semaglutide). All treatment doses were orally administered once daily (3 mg for the 1st month, 7 mg for the 2nd month, and 14 mg for the 3rd and 4th months after the placement of the swallow balloon). All the data were statistically analysed. RESULTS The groups were highly well-matched. The %TWL in group I was 7.9%, 12.5%, 15.2%, and 17.6% and in group II was 6.1%, 10.5%, 12.8%, and 13.7% at 1, 2, 3, and 4 months, respectively. The most common adverse events (AEs) were nausea and vomiting, observed within the week. The resolution of T2DM, HTN, and OSA was 64.7% vs 55.5%, 64.3% vs 58.8%, and 72.0 vs 57.8% in groups I vs II, respectively. QoL significantly improved 4 months postoperatively in both groups. No major late complications occurred in either of the groups. CONCLUSION The study supports the efficacy of swallow balloon therapy combined with semaglutide oral formulation in promoting weight loss and improving comorbid conditions. The findings highlight the potential of this combined approach in managing obesity and its associated health issues.
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Affiliation(s)
- Winni Mathur
- Mohak Bariatrics and Robotics Center, Sri Aurobindo University, Indore-Ujjain Highway, Indore, Madhya Pradesh, 453555, India
| | - Susmit Kosta
- Mohak Bariatrics and Robotics Center, Sri Aurobindo University, Indore-Ujjain Highway, Indore, Madhya Pradesh, 453555, India
| | - Manoj Reddy
- Mohak Bariatrics and Robotics Center, Sri Aurobindo University, Indore-Ujjain Highway, Indore, Madhya Pradesh, 453555, India
| | - Manoel Galvao Neto
- Mohak Bariatrics and Robotics Center, Sri Aurobindo University, Indore-Ujjain Highway, Indore, Madhya Pradesh, 453555, India
| | - Mohit Bhandari
- Mohak Bariatrics and Robotics Center, Sri Aurobindo University, Indore-Ujjain Highway, Indore, Madhya Pradesh, 453555, India.
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Abdulla M, Mohammed N, AlQamish J. Overview on the endoscopic treatment for obesity: A review. World J Gastroenterol 2023; 29:5526-5542. [PMID: 37970474 PMCID: PMC10642436 DOI: 10.3748/wjg.v29.i40.5526] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/03/2023] [Revised: 09/15/2023] [Accepted: 10/23/2023] [Indexed: 10/27/2023] Open
Abstract
Obesity rates have increased, and so has the need for more specific treatments. This trend has raised interest in non-surgical weight loss techniques that are novel, safe, and straightforward. Thus, the present review describes the endoscopic bariatric treatment for obesity, its most recent supporting data, the questions it raises, and its future directions. Various endoscopic bariatric therapies for weight reduction, such as intragastric balloons (IGBs), aspiration therapy (AT), small bowel endoscopy, endoscopic sleeve gastroplasty, endoluminal procedures, malabsorption endoscopic procedures, and methods of regulating gastric emptying, were explored through literature sourced from different databases. IGBs, AT, and small bowel endoscopy have short-term effects with a possibility of weight regain. Minor adverse events have occurred; however, all procedures reduce weight. Vomiting and nausea are common side effects, although serious complications have also been observed.
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Affiliation(s)
- Maheeba Abdulla
- Department of Internal Medicine, Ibn Al Nafees Hospital, Manama 54533, Bahrain
| | - Nafeesa Mohammed
- Department of Intensive Care Unit, Salmaniya Medical Complex, Manama 5616, Bahrain
| | - Jehad AlQamish
- Department of Internal Medicine, Ibn Al Nafees Hospital, Manama 54533, Bahrain
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Norton BC, Telese A, Papaefthymiou A, Aslam N, Makaronidis J, Murray C, Haidry R. Metabolic and Bariatric Endoscopy: A Mini-Review. Life (Basel) 2023; 13:1905. [PMID: 37763308 PMCID: PMC10532500 DOI: 10.3390/life13091905] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2023] [Revised: 09/07/2023] [Accepted: 09/08/2023] [Indexed: 09/29/2023] Open
Abstract
We are currently in a worldwide obesity pandemic, which is one of the most significant health problems of the 21st century. As the prevalence of obesity continues to rise, new and innovate treatments are becoming available. Metabolic and bariatric endoscopic procedures are exciting new areas of gastroenterology that have been developed as a direct response to the obesity crisis. These novel interventions offer a potentially reversible, less invasive, safer, and more cost-effective method of tackling obesity compared to traditional bariatric surgery. Minimally invasive endoscopic treatments are not entirely novel, but as technology has rapidly improved, many of the procedures have been proven to be extremely effective for weight loss and metabolic health, based on high-quality clinical trial data. This mini-review examines the existing evidence for the most prominent metabolic and bariatric procedures, followed by a discussion on the future trajectory of this emerging subspecialty.
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Affiliation(s)
- Benjamin Charles Norton
- Digestive Diseases and Surgery Institute, Cleveland Clinic London, 33 Grosvenor Pl, London SW1X 7HY, UK
- Department of Gastroenterology, University College London Hospital Euston Road, London NW1 2BU, UK
- Centre for Obesity Research, Rayne Institute, Department of Medicine, University College London, London WC1E 6BT, UK
| | - Andrea Telese
- Digestive Diseases and Surgery Institute, Cleveland Clinic London, 33 Grosvenor Pl, London SW1X 7HY, UK
- Centre for Obesity Research, Rayne Institute, Department of Medicine, University College London, London WC1E 6BT, UK
| | - Apostolis Papaefthymiou
- Department of Gastroenterology, University College London Hospital Euston Road, London NW1 2BU, UK
| | - Nasar Aslam
- Department of Gastroenterology, University College London Hospital Euston Road, London NW1 2BU, UK
| | - Janine Makaronidis
- Centre for Obesity Research, Rayne Institute, Department of Medicine, University College London, London WC1E 6BT, UK
- Bariatric Centre for Weight Management and Metabolic Surgery, University College London Hospital, London WC1E 6BT, UK
- Department of Endocrinology and Diabetes, University College London Hospital, London WC1E 6BT, UK
- National Institute of Health Research, UCLH Biomedical Research Centre, London W1T 7DN, UK
| | - Charles Murray
- Digestive Diseases and Surgery Institute, Cleveland Clinic London, 33 Grosvenor Pl, London SW1X 7HY, UK
| | - Rehan Haidry
- Digestive Diseases and Surgery Institute, Cleveland Clinic London, 33 Grosvenor Pl, London SW1X 7HY, UK
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Dave N, Dawod E, Simmons OL. Endobariatrics: a Still Underutilized Weight Loss Tool. CURRENT TREATMENT OPTIONS IN GASTROENTEROLOGY 2023; 21:172-184. [PMID: 37284352 PMCID: PMC10163575 DOI: 10.1007/s11938-023-00420-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Accepted: 03/08/2023] [Indexed: 06/08/2023]
Abstract
Purpose of review Bariatric and metabolic endoscopic therapies provide an option for patients seeking clinically significant weight loss with fewer adverse events than conventional bariatric surgery. Our aims are to provide an overview of the current state of primary endoscopic treatment options for weight loss and to emphasize the importance of including these therapies when presenting weight loss options to qualified patients. Recent findings Bariatric endoscopy procedures are associated with a lower adverse event rate when compared to bariatric surgery and result in more weight loss than most existing pharmacotherapies approved by the Food and Drug Administration. Summary Sufficient evidence exists to implement bariatric endoscopic therapies-namely, the intragastric balloon and endoscopic sleeve gastroplasty-as safe and effective treatment options for weight loss when used in combination with lifestyle changes. However, bariatric endoscopy remains an underutilized option by weight management providers. Future studies are needed to identify patient and provider-level barriers to adopting endoscopic bariatric therapies as an option for the treatment of obesity.
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Affiliation(s)
- Niel Dave
- Division of Gastroenterology at HCA Florida Aventura Hospital, 20900 Biscayne Blvd, Aventura, FL 33180 USA
| | - Enad Dawod
- Division of Gastroenterology, Weill Cornell Medicine, New York Presbyterian Hospital, 1305 York Avenue, 4th Floor, New York, NY 10021 USA
| | - Okeefe L. Simmons
- Simmons MD Advanced Weight Loss Solutions, 2820 NE 214th Street, Suite 1002, Miami, FL 33180 USA
- Division of Gastroenterology, Miami Veterans Affairs Healthcare System, 1201 NW 16th Street, Miami, FL 33125 USA
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Bawahab MA, Abbas KS, Maksoud WMAE, Abdelgadir RS, Altumairi K, Alqahtani AR, Alzahrani HA, Bhat MJ. Factors Affecting Weight Reduction after Intragastric Balloon Insertion: A Retrospective Study. Healthcare (Basel) 2023; 11:healthcare11040600. [PMID: 36833134 PMCID: PMC9957044 DOI: 10.3390/healthcare11040600] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2022] [Revised: 02/11/2023] [Accepted: 02/16/2023] [Indexed: 02/19/2023] Open
Abstract
BACKGROUND AND OBJECTIVES Intragastric balloon (IGB) is a safe option for obesity management. However, studies determining the factors influencing the procedure's outcomes are scarce. Therefore, our goal was to determine the factors affecting weight reduction after IGB insertion. MATERIALS AND METHODS This retrospective study included 126 obese patients who underwent IGB treatment using the ORBERA® Intragastric Balloon System. Patients' records were retrieved; and demographic data, initial body mass index (BMI), complications, compliance with both diet and exercise programs, and percentage of excess weight reduction were recorded. RESULTS The study included 108 female (85.7%) and 18 male (14.3%) patients. The mean age was 31.7 ± 8.1 years. The percentage of excess weight loss (EWL) was 55.8 ± 35.7%. The mean weight loss was 13.01 ± 7.51 kg. A significant association was found between EWL and age, initial weight, initial body mass index, and the number of pregnancies. No major complications were observed. However, the balloon had to be removed early in two patients (1.59%) due to its rupture and in two other patients (1.59%) due to severe gastritis. CONCLUSIONS IGB therapy is a safe and effective option for obesity management, associated with low rates of complications. The EWL after IGB insertion is significantly higher among older patients, those with a relatively low initial body mass index, those with a longer duration of IGB insertion, and female patients with less parity. Larger prospective studies are needed to support our results.
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Affiliation(s)
- Mohammed A. Bawahab
- Surgery Department, Faculty of Medicine, King Khalid University, P.O. Box 641, Abha 61421, Saudi Arabia
| | - Khaled S. Abbas
- Surgery Department, Faculty of Medicine, King Khalid University, P.O. Box 641, Abha 61421, Saudi Arabia
| | - Walid M. Abd El Maksoud
- Surgery Department, Faculty of Medicine, King Khalid University, P.O. Box 641, Abha 61421, Saudi Arabia
- Correspondence: ; Tel.: +966-543128555
| | - Reem S Abdelgadir
- General Surgery, Abha International Private Hospital, Abha 62521, Saudi Arabia
| | | | - Awadh R. Alqahtani
- Surgery Department, Faculty of Medicine, King Saud University, Riyadh 11461, Saudi Arabia
| | - Hassan A. Alzahrani
- Surgery Department, Faculty of Medicine, King Khalid University, P.O. Box 641, Abha 61421, Saudi Arabia
| | - Muneer Jan Bhat
- Anesthesia, Surgery Department, Faculty of Medicine, King Khalid University, Abha 61421, Saudi Arabia
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Espinet Coll E, Del Pozo García AJ, Turró Arau R, Nebreda Durán J, Cortés Rizo X, Serrano Jiménez A, Escartí Usó MÁ, Muñoz Tornero M, Carral Martínez D, Bernabéu López J, Sierra Bernal C, Martínez-Ares D, Espinel Díez J, Marra-López Valenciano C, Sola Vera J, Sanchis Artero L, Domínguez Jiménez JL, Carreño Macián R, Juanmartiñena Fernández JF, Fernández Zulueta A, Consiglieri Alvarado C, Grecco E, Bezerra Silva L, Galvao Neto M. Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2023; 115:22-34. [PMID: 36426855 DOI: 10.17235/reed.2022.9322/2022] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
BACKGROUND intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.
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Affiliation(s)
| | | | - Román Turró Arau
- Aparato Digestivo. Endoscopia Digestiva-Bariátrica, Hospital Teknon
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | - Eduardo Grecco
- Aparato Digestivo y Endoscopia, Instituto EndoVitta y ABC Medical School, Mário Covas State Hospital
| | | | - Manoel Galvao Neto
- Endoscopia y Cirugía Bariátrica, Instituto EndoVitta y ABC Medical School, Sao Paulo, Brazil. Saims Medical College, Brasil
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11
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Williams K, Nadler EP. The Role of Devices in the Management of Pediatric Obesity. Curr Obes Rep 2022; 11:55-60. [PMID: 35737260 DOI: 10.1007/s13679-022-00476-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/18/2022] [Indexed: 11/03/2022]
Abstract
PURPOSE OF REVIEW Approximately 20% of children and adolescents in the USA suffer from obesity with significant long-term effects well into adulthood. Metabolic and bariatric surgery, although well adopted in the adult population, has been underutilized in children. RECENT FINDINGS There are four categories of weight loss devices regulated by the Food and Drug Administration for use in adults - gastric bands, gastric balloon systems, electrical stimulation systems, and gastric emptying systems. In this commentary we discuss the role these devices may play in increasing the adoption of procedural intervention for severe obesity in children and adolescents.
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Affiliation(s)
- Kibileri Williams
- Division of Pediatric Surgery, Children's National Hospital, 111 Michigan Ave. NW, Washington, DC, 20010, USA.
| | - Evan P Nadler
- Division of Pediatric Surgery, Children's National Hospital, 111 Michigan Ave. NW, Washington, DC, 20010, USA.
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12
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Pietrabissa G, Bertuzzi V, Simpson S, Guerrini Usubini A, Cattivelli R, Bertoli S, Mozzi E, Roviaro G, Castelnuovo G, Molinari E. Psychological Aspects of Treatment with Intragastric Balloon for Management of Obesity: A Systematic Review of the Literature. Obes Facts 2022; 15:1-18. [PMID: 34818229 PMCID: PMC8820150 DOI: 10.1159/000518200] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2021] [Accepted: 06/24/2021] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION Optimizing maintenance of weight loss for people with obesity following intragastric balloon (IGB) therapy hinges on the degree to which health care providers can recognize both the impact of emotional problems and mood difficulties on their capacity to self-manage, and requirements for additional support. However, there is limited research on the psychological correlates of IGB therapy. This systematic review, for the first time, attempts to identify and synthesize the empirical evidence for the reciprocal influence between psychological variables and IGB outcomes. METHODS A literature search was performed in the PubMed, SCOPUS, MEDLINE, and Google Scholar databases. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed using rigorous inclusion criteria and screening by at least 2 reviewers. The selected articles were assessed for quality using the Strengthening the Reporting of Observational Studies Epidemiology (STROBE) checklist. Data were extracted to address the review aims and presented as a narrative synthesis. The review protocol was preregistered (Prospero CRD42019121291). RESULTS A total of 16,179 titles, 14,369 abstracts, and 51 full-text articles were screened, of which 16 studies were included. Findings suggest that female gender, older age, basic educational level, and single/divorced civil status, together with lower levels of depression, binge eating, higher perceived quality of life, and motivation to change were predictors of enhanced IGB treatment outcomes. Dissatisfaction with treatment was higher in those with impaired obesity-related social-life difficulties. The IGB treatment was effective in reducing weight and improving depression, anxiety, eating disorder symptoms, and the overall life quality of patients with obesity - mainly within 6 months from the device positioning and in conjunction with conventional therapies. DISCUSSION/CONCLUSION In line with the available literature on obesity and bariatric surgery interventions, poor mental health appears to be an important barrier for successful weight loss among patients with obesity undergoing IGB treatment. In order to improve the efficacy and effectiveness of the IGB therapy, more comprehensive and standardized studies are needed to provide insight into the psychological mechanisms maintaining weight management issues.
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Affiliation(s)
- Giada Pietrabissa
- Department of Psychology, Catholic University of Milan, Milan, Italy,
- Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy,
| | - Vanessa Bertuzzi
- Department of Psychology, Catholic University of Milan, Milan, Italy
| | - Susan Simpson
- Department of Justice and Society, University of South Australia, Adelaide, South Australia, Australia
- Regional Eating Disorders Unit, NHS Lothian, Edinburgh, United Kingdom
| | - Anna Guerrini Usubini
- Department of Psychology, Catholic University of Milan, Milan, Italy
- Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy
| | - Roberto Cattivelli
- Department of Psychology, Catholic University of Milan, Milan, Italy
- Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy
| | - Simona Bertoli
- Department of Endocrine and Metabolic Diseases, Obesity Unit and Laboratory of Nutrition and Obesity Research, Istituto Auxologico Italiano IRCCS, Milan, Italy
- Department of Food, Environmental and Nutritional Sciences, International Center for the Assessment of Nutritional Status, University of Milan, Milan, Italy
| | - Enrico Mozzi
- Division of General Surgery, Istituto Auxologico Italiano IRCCS, Milan, Italy
| | - Giancarlo Roviaro
- Division of General Surgery, Istituto Auxologico Italiano IRCCS, Milan, Italy
| | - Gianluca Castelnuovo
- Department of Psychology, Catholic University of Milan, Milan, Italy
- Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy
| | - Enrico Molinari
- Department of Psychology, Catholic University of Milan, Milan, Italy
- Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy
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Silva LB, Neto MG. Intragastric balloon. MINIM INVASIV THER 2021; 31:505-514. [PMID: 33571068 DOI: 10.1080/13645706.2021.1874420] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
The intragastric balloon is a temporary and minimally invasive therapy for weight loss, currently being the main choice for mild obesity. As a space-occupying device, it reduces stomach capacity, resulting in decreased hunger and food intake. There are different balloon models, filled with liquid or air. The most used is the non-adjustable liquid-filled balloon, due to its lower rate of complications. The mechanism of action is multifactorial, involving physiological and neurohormonal changes. The device functions as an artificial bezoar, filling the stomach and leading to early satiety. In the Brazilian Intragastric Balloon Consensus Statement, there was a mean excess weight loss of 18.4%, showing effective weight loss and good safety profile. It is a valid option for overweight and obese patients unresponsive to clinical therapy or who are either not candidates for surgery or who do not wish to undergo a definitive procedure. Besides weight loss, recent studies have shown a positive effect on metabolic parameters. New devices have been developed, such as procedureless and adjustable balloons, with promising results.
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Affiliation(s)
- Lyz Bezerra Silva
- Department of Surgery, Federal University of Pernambuco, Recife, Brazil
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14
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BARUTÇU S, YILDIRIM AE, KONDUK BT. İntragastrik Obezite Balonu'nun Karanlık Yollarda Gizemli Kayboluşu: İki Olgu ve Literatürün Gözden Geçirilmesi. KAHRAMANMARAŞ SÜTÇÜ İMAM ÜNIVERSITESI TIP FAKÜLTESI DERGISI 2020. [DOI: 10.17517/ksutfd.741480] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022] Open
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Jung SH, Yoon JH, Choi HS, Nam SJ, Kim KO, Kim DH, Kim JW, Sohn W, Hyun YS, Park CH, Lee HL. Comparative efficacy of bariatric endoscopic procedures in the treatment of morbid obesity: a systematic review and network meta-analysis. Endoscopy 2020; 52:940-954. [PMID: 32325513 DOI: 10.1055/a-1149-1862] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND The comparative efficacy of bariatric endoscopic procedures has not been completely elucidated. We aimed to comprehensively evaluate the efficacy of bariatric endoscopic procedures. METHODS We searched for randomized controlled trials investigating the efficacy of bariatric endoscopic procedures, including the use of an intragastric balloon, duodenal-jejunal bypass liner (DJBL), aspiration therapy, primary obesity surgery endoluminal (POSE) procedure, and botulinum toxin injection to the stomach. Network meta-analyses were performed to determine the percentage of weight loss (%weight loss) and percentage of excess weight loss (%EWL). RESULTS 22 studies with 2141 patients were included in the meta-analysis. Most endoscopic procedures showed superior efficacy in terms of %weight loss compared with the control (mean difference [MD] [95 % confidence interval (CI)]: aspiration therapy 10.4 % [7.0 % to 13.7 %]; fluid-filled balloon 5.3 % [3.4 % to 7.2 %]; POSE 4.9 % [1.7 % to 8.2 %]; and DJBL 4.5 % [1.4 % to 7.7 %]). In terms of %EWL, aspiration therapy, fluid-filled balloon, POSE, and DJBL were superior to the control (MD [95 %CI]: 27.3 % [15.3 % to 39.3 %]; 22.4 % [15.4 % to 29.4 %]; 15.3 % [2.5 % to 28.0 %]; and 13.0 % [4.9 % to 21.2], respectively). The gas-filled balloon and botulinum toxin injection did not show a significant difference in %weight loss or %EWL compared with the control. For the fluid-filled balloon, the %EWL and %weight loss tended to decrease after balloon removal at 6 months after the procedure. CONCLUSION All bariatric endoscopic procedures, except for gas-filled balloon and botulinum toxin injection to the stomach, showed superior short-term efficacy in terms of %weight loss or %EWL compared with lifestyle modification.
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Affiliation(s)
- Sung Hoon Jung
- Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Jai Hoon Yoon
- Division of Gastroenterology, Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Korea
| | - Hyuk Soon Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
| | - Seung-Joo Nam
- Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea
| | - Kyoung Oh Kim
- Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
| | - Do Hoon Kim
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
| | - Jung-Wook Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea
| | - Won Sohn
- Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Yil Sik Hyun
- Division of Gastroenterology, Department of Internal Medicine, Seoul Chuk Hospital, Seoul, Korea
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea
| | - Hang Lak Lee
- Division of Gastroenterology, Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Korea
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Lucido FS, Scotti L, Scognamiglio G, Gambardella C, Brusciano L, Del Genio G, Pizza F, Ruggiero R, Parmeggiani D, Nesta G. Gastric perforation by intragastric balloon: Laparoscopic gastric wedge resection can be a strategy? Int J Surg Case Rep 2020; 77S:S88-S91. [PMID: 33041259 PMCID: PMC7876839 DOI: 10.1016/j.ijscr.2020.09.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Revised: 09/01/2020] [Accepted: 09/01/2020] [Indexed: 12/03/2022] Open
Abstract
Gastric perforation caused by intragastric balloon represents a rare but life-threatening complication. There is a lack of information about perforation in the same day of surgery. An endoscopic and laparoscopic approach with a gastric wedge resection was performed. Introduction IGB (Intragastric Balloon) is acknowledged to be a safe and secure device, whose outcomes in terms of weight loss are widely discussed. Bariatric community has soon noted tolerance and benefit of this tool, considered a first and easy step before bariatric surgery. Nevertheless, some authors have described a series of complications that, although rare, could be life threatening and hard to manage, as a gastric perforation. Presentation of case We reported a case of a 55-year-old obese woman, undergone placement of IGB device heisting in a gastric perforation. In the same day of surgery, we performed an emergency, applying a combined endoscopic and laparoscopic approach, to remove the balloon and to close perforation by a gastric resection. Discussion. Short term outcome was satisfactory, and the patient had a successful further follow up and weight loss. Conclusion IGB is a valuable tool among bariatric procedure, nevertheless the surgeon has to consider the possible and life-threatening complications and to provide a multidisciplinary equip to face this occurrence.
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Affiliation(s)
- Francesco Saverio Lucido
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy.
| | - Luigi Scotti
- General and Bariatric Surgery Unit, Camilliani Hospital, Casoria, Italy
| | | | - Claudio Gambardella
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy; Department of Cardiothoracic Sciences, University of Campania "Luigi Vanvitelli", School of Medicine, Naples, Italy
| | - Luigi Brusciano
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy
| | - Gianmattia Del Genio
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy
| | - Francesco Pizza
- Division of Surgery, Hospital "A. Rizzoli", Lacco Ameno, Naples, Italy
| | - Roberto Ruggiero
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy
| | - Domenico Parmeggiani
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy
| | - Giusiana Nesta
- Division of General, Mini-Invasive and Obesity Surgery- Master of Coloproctology and Master of Pelvi-Perineal Rehabilitation, University of Study of Campania "Luigi Vanvitelli", Naples, Italy
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Do Endoscopic Bariatric Procedures Improve Postprocedural Quality of Life and Mental Health? A Systematic Review and Meta-analysis. Obes Surg 2020; 30:4091-4100. [PMID: 32761319 DOI: 10.1007/s11695-020-04860-2] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2020] [Revised: 07/08/2020] [Accepted: 07/11/2020] [Indexed: 02/08/2023]
Abstract
Quality of life and mental health are important outcomes of bariatric therapy. This review aimed to determine endoscopic bariatric procedures' impact on postprocedural quality of life and mental health. Four electronic databases were systematically searched. Studies with adults > 18 years who underwent an endoscopic bariatric procedure and reported pre- and postprocedural quality of life and/or mental health using a validated tool were included. Meta-analyses were conducted using RevMan and study quality was assessed. Twenty studies evaluating five different endoscopic procedures were included (N = 876 total sample size). Intragastric balloon placement was associated with a large improvement in postprocedural quality of life and mental health. Endoscopic bariatric therapies may improve short-term quality of life and mental health alongside weight loss and comorbidity improvement.
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18
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Kotinda APST, de Moura DTH, Ribeiro IB, Singh S, da Ponte Neto AM, Proença IM, Flor MM, de Souza KL, Bernardo WM, de Moura EGH. Efficacy of Intragastric Balloons for Weight Loss in Overweight and Obese Adults: a Systematic Review and Meta-analysis of Randomized Controlled Trials. Obes Surg 2020; 30:2743-2753. [PMID: 32300945 DOI: 10.1007/s11695-020-04558-5] [Citation(s) in RCA: 26] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Intragastric balloons (IGB) are the most widely used endoscopic bariatric and metabolic therapies. We aimed to evaluate the efficacy of IGB in comparison with sham or lifestyle interventions for weight loss in overweight and obese patients. This systematic review and meta-analysis was performed following the PRISMA guidelines. Electronic searches were performed to identify randomized controlled trials, which compared IGB with sham or lifestyle intervention. Thirteen RCTs with 1523 patients were included. The difference in mean %EWL and %TWL at follow-up was 17.98%, and 4.40%, respectively, which was significantly higher in the IGB group. Similarly, the difference in mean AWL and BMIL was 6.12 kg, and 2.13 kg/m2, respectively. IGB therapy is more effective than lifestyle intervention alone for weight loss in overweight and obese adults.
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Affiliation(s)
- Ana Paula Samy Tanaka Kotinda
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
| | | | - Igor Braga Ribeiro
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.
- , Av. Dr Enéas de Carvalho Aguiar, 225, 6o andar, bloco 3, Cerqueira Cesar, São Paulo, SP, 05403-010, Brazil.
| | - Shailendra Singh
- Division of Gastroenterology, West Virginia University Health Sciences Center Charleston Division, Charleston, WV, USA
| | - Alberto Machado da Ponte Neto
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
| | - Igor Mendonça Proença
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
| | - Marcelo Mochate Flor
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
| | | | - Wanderley Marques Bernardo
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
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Brunaldi VO, Galvao Neto M. Gastric space-occupying devices for management of obesity and metabolic disease. ACTA ACUST UNITED AC 2020. [DOI: 10.1016/j.tige.2020.05.001] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
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20
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Usuy E, Silva M, Dos Passos Galvão Neto M, Grecco E, Ferreira de Souza T, de Quadros LG. Antibiotics to Prevent Relapse of Adjustable Gastric Balloon Hyperinflation: Feasible for Balloon Maintenance? GE-PORTUGUESE JOURNAL OF GASTROENTEROLOGY 2020; 28:52-55. [PMID: 33564704 DOI: 10.1159/000507226] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/30/2019] [Accepted: 01/18/2020] [Indexed: 02/06/2023]
Abstract
The placement of an intragastric balloon (IGB) plays an increasingly important role in the treatment of obesity. The authors describe the cases of 2 female patients, 34 and 62 years old, who were submitted to the implantation of a Spatz3® IGB to treat obesity. Ten to fourteen weeks later, the patients presented complaints of epigastric pain, vomiting, and abdominal distension. A bulging of the upper abdominal wall was noticed upon physical examination. Upper gastrointestinal endoscopy confirmed the clinical suspicion of IGB hyperinflation. It was decided to remove the 500 mL of saline solution with methylene blue from inside the balloon. During the same procedure, the IGB was refilled with 500 mL of fresh saline solution, methylene blue, and empiric β-lactam antibiotic. The extracted content of the hyperinflated IGB was sent for microbiological culturing and was found to be positive for Streptococcus viridans in one of the cases. In the other case, the culture examination was negative, and after 8 weeks, the patient presented again with hyperinflation of the IGB. It was then decided to substitute the IGB with another balloon; the procedure was uneventful. The content of the removed IGB was sent for microbiological testing, and colonization by Candida tropicaliswas confirmed. This is a rare but potentially serious complication of IGB placement. Randomized trials are needed to clarify the role of antibiotics and antifungals in primary and secondary prophylaxis against IGB hyperinflation.
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Affiliation(s)
| | - Marco Silva
- Gastroenterology Department, Centro Hospitalar de São João, Porto Medical School, Porto, Portugal
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21
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Patients undergoing intragastric balloon achieve approximately 50% of their target weight loss in the first month postoperatively: an MBSAQIP analysis. Surg Obes Relat Dis 2019; 15:2060-2065. [DOI: 10.1016/j.soard.2019.05.024] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2019] [Revised: 05/13/2019] [Accepted: 05/13/2019] [Indexed: 02/08/2023]
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Hay D, Ryan G, Somasundaram M, Yip V, Navaratne L. Laparoscopic management of a migrated intragastric balloon causing mechanical small bowel obstruction: a case report and review of the literature. Ann R Coll Surg Engl 2019; 101:e172-e177. [PMID: 31672034 PMCID: PMC6818066 DOI: 10.1308/rcsann.2019.0104] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/29/2019] [Indexed: 12/13/2022] Open
Abstract
Intragastric balloons have been used as an invasive non-surgical treatment for obesity for over 30 years. Within the last 37 years, we have found only 27 cases reported in the literature of intestinal obstruction caused by a migrated intragastric balloon. We report the laparoscopic management of such a case and make observations from similar case presentations published in the literature. A 26-year-old woman had an intragastric balloon placed endoscopically for weight control 13 months previously. She presented to the emergency department with a four-day history of intermittent abdominal cramps and vomiting. Contrast enhanced computed tomography confirmed the presence of the intragastric balloon within the small bowel. At laparoscopic retrieval, the deflated intragastric balloon was found impacted in the terminal ileum approximately 15 cm from the ileocaecal valve. The balloon was retrieved by enterotomy and primary closure of the ileum without event. The risk of balloon deflation and subsequent migration increases over time but several published cases demonstrate that this complication can occur within six months of insertion. The initial approach to the treatment of migrated intragastric balloons causing small bowel obstruction should be determined by the location of impaction, severity of obstruction and the available skill set of the attending radiologist, endoscopist and/or surgeon. Balloons causing obstruction in the duodenum are likely amenable to endoscopic retrieval whereas impaction within the jejunum or ileum could be managed by percutaneous needle aspiration (in selected cases), endoscopy (double-balloon enteroscopy), laparoscopy or open surgery.
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Affiliation(s)
- D Hay
- Department of General Surgery, Royal London Hospital, London, UK
| | - G Ryan
- Department of General Surgery, Royal London Hospital, London, UK
| | - M Somasundaram
- Department of General Surgery, Royal London Hospital, London, UK
| | - V Yip
- Department of General Surgery, Royal London Hospital, London, UK
| | - L Navaratne
- Department of General Surgery, Royal London Hospital, London, UK
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The Impact of Dietician Support and Behavioural Therapy in Addition to Concomitant Treatment with Intragastric Balloon in Obese Patients. Obes Surg 2019; 30:612-617. [PMID: 31650406 DOI: 10.1007/s11695-019-04228-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
INTRODUCTION AND AIMS Patients treated with intragastric balloon (IGB) may benefit from treatment and follow-up by a multidisciplinary team, where the dietician is considered the only essential professional besides the endoscopist. The aim of this study is to evaluate the impact of dietician support and behavioral therapy in terms of weight loss in patients concomitantly treated with IGB while the device is in situ. METHODS Patients with IGB in situ, in period 2005-2018, were invited to undergo a dietician check-up (DC) every 1.5 months, accompanied by cognitive behavioral therapy. Considering their attendance at the dietician check-ups (DCs), patients were categorized as non-compliant (0 DC), partially compliant (1-2 DCs), and highly compliant (≥ 3 DCs). A comparison was made among the three groups regarding % of total body weight loss (%TBWL) and ΔBMI at 180 ± 15 days when the IGB was in situ. RESULTS One hundred eighty-three obese patients treated with fluid-filled IGB were included. Body weight data at 180 ± 15 days during the IGB in situ, as well as attendance at the DCs, were available for 170 out of 183 patients. There was no difference among compliant, partially compliant, and non-compliant patients to DCs regarding %TBWL at 180 ± 15 days (p = 0.17). However, non-compliant patients had a higher ΔBMI at 180 ± 15 days in comparison to those compliant or partially compliant to DCs (p = 0.03). CONCLUSION Despite its undisputed educational role, attendance at DCs does not seem to correlate with an additional weight loss while the IGB is in situ.
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Fluid-Filled Versus Gas-Filled Intragastric Balloons as Obesity Interventions: a Network Meta-analysis of Randomized Trials. Obes Surg 2019; 28:2617-2625. [PMID: 29663250 DOI: 10.1007/s11695-018-3227-7] [Citation(s) in RCA: 40] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND Four commercially available intragastric balloons have been used for the management of obesity and underwent randomized controlled trials (RCTs), and we aimed to compare them using a network meta-analysis approach. METHODS Several databases were queried from inception to May 26, 2017, and we included RCTs enrolling patients treated with Orbera, Heliosphere, ReShape Duo, and Obalon compared with another balloon, sham, or open-label control group. Two investigators independently abstracted data. A random effects frequentist network meta-analysis and relative ranking of agents using surface under the cumulative ranking probabilities were performed. RESULTS We included 15 trials at low risk of bias (only two were head-to-head). Compared to control groups, the two fluid-filled devices were associated with significant outcome (% total body weight loss) at 6 months: Orbera, 6.72% (95% CI, 5.55, 7.89) and ReShape Duo 4% (95% CI 2.69, 5.31). Only one of the two gas-filled devices was associated with significant outcome at 6 months: Obalon 3.3% (95% CI 2.30, 4.30), and not the second: Heliosphere 6.71% (95% CI - 0.82, 14.23). Fluid-filled devices had the highest likelihood of superiority in achieving the outcome at 6 months (96.8%) and at 12 months (96.6%). The quality of evidence was high for comparisons against control. CONCLUSIONS Fluid-filled balloons are more likely to produce weight loss compared to gas-filled balloons or lifestyle intervention. However, they may be associated with a higher rate of intolerance and early removal. This information will aid clinicians in device selection and engaging patients in shared decision-making.
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Abstract
Intragastric balloons (IGBs) are the most widely available endoscopic bariatric therapy for class I and II obesity in the United States. Although simple in application and reversible by nature, these devices may help patients initiate the important first steps in weight loss maintenance, provided that parallel efforts are in motion to prevent weight recidivism. Too often, therapeutic nihilism stems from unrealistic expectations of a given therapy. In the case of IGBs, this sentiment may occur when these interventions are applied in a vacuum and not within the purview of a multidisciplinary program that actively involves dieticians, endocrinologists, gastroenterologists, and surgeons. There is a clear and present need to apply different tactics in the remissive strategy to control the obesity pandemic, more so in a struggling landscape of an ever-widening gap in bridging interventions. With such demand, the IGB is an available tool that could be helpful when correctly implemented. In this exposition, we summarize the current state of IGBs available worldwide, discuss their mechanism of action, relay evidence for their short- and long-term efficacy, address safety profile concerns, and suggest procedural considerations in the real-world quotidian application.
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Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, Marra-López Valenciano C, Turró Arau R, Esteban López-Jamar JM, Muñoz-Navas M. Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2019; 111:140-154. [PMID: 30654612 DOI: 10.17235/reed.2019.4922/2017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.
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Choi SJ, Choi HS. Various Intragastric Balloons Under Clinical Investigation. Clin Endosc 2018; 51:407-415. [PMID: 30257544 PMCID: PMC6182294 DOI: 10.5946/ce.2018.140] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/16/2018] [Revised: 09/17/2018] [Accepted: 09/17/2018] [Indexed: 12/21/2022] Open
Abstract
Obesity is a chronic disease with an exponentially increasing incidence rate, and its negative effects are well documented in numerous studies. As a result, the importance of bariatric therapy cannot be overemphasized, and many bariatric treatment methods with varying mechanisms have been developed. Of the available treatment methods, intragastric balloons, introduced in the 1980s, have been shown to be a safe and effective treatment modality; various intragastric balloon products have been developed and are currently being widely used in clinical settings. However, the disadvantages of intragastric balloons, such as unclear long-term weight loss benefits and complications experienced during insertion and removal, preclude their wider use. In this review, we discuss different intragastric balloon products, focusing on those under clinical investigation, and suggest future research directions.
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Affiliation(s)
- Seong Ji Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Korea
| | - Hyuk Soon Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Korea
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BORGES ALANACOSTA, ALMEIDA PAULOCÉSAR, FURLANI STELLAMT, CURY MARCELODESOUSA, GAUR SHANTANU. Intragastric balloons in high-risk obese patients in a Brazilian center: initial experience. Rev Col Bras Cir 2018; 45:e1448. [DOI: 10.1590/0100-6991e-20181448] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2017] [Accepted: 09/28/2017] [Indexed: 02/07/2023] Open
Abstract
ABSTRACT Objective: to assess the short-term efficacy, tolerance and complications in high-risk morbidly obese patients treated with an intragastric balloon as a bridge for surgery. Methods: we conducted a post-hoc analysis study in a Brazilian teaching hospital from 2010 to 2014, with 23 adult patients with a BMI of 48kg/m2, who received a single intragastric air or liquid balloon. We defined efficacy as 10% excess weight loss, and complications, as adverse events consequent to the intragastric balloon diagnosed after the initial accommodative period. We expressed the anthropometric results as means ± standard deviation, comparing the groups with paired T / Student’s T tests, when appropriate, with p<0.05 considered statistically significant. Results: the balloons were effective in 91.3% of the patients, remained in situ for an average of 5.5 months and most of them (65.2%) were air-filled, with a mean excess weight loss of 23.7kg±9.7 (excess weight loss 21.7%±8.9) and mean BMI reduction of 8.3kg/m2±3.3. Complications (17.3%) included abdominal discomfort, balloon deflation and late intolerance, without severe cases. Most of the participants (82.7%) did not experience adverse effects. We removed the intragastric balloons in time, without intercurrences, and 52.2% of these patients underwent bariatric surgery within one month. Conclusion: in our center, intragastric balloons can be successfully used as an initial weight loss procedure, with good tolerance and acceptable complications rates.
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Efficacy of First-Time Intragastric Balloon in Weight Loss: a Systematic Review and Meta-analysis of Randomized Controlled Trials. Obes Surg 2017; 27:277-287. [PMID: 27465936 DOI: 10.1007/s11695-016-2296-8] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND The intragastric balloon (IGB) is an adjunctive treatment for obesity. This meta-analysis aimed to evaluate the efficacy and safety of IGB treatment by reviewing randomized controlled trials (RCTs). METHODS A total of 20 RCTs involving 1195 patients were identified. Weight loss results before and after 3 months were analyzed separately. The weight loss results of patients with and without IGB treatment were compared. RESULTS Our meta-analysis calculated the following significant effect sizes: 1.59 and 1.34 kg/m2 for overall and 3-month BMI loss, respectively; 14.25 and 11.16 % for overall and >3-month percentage of excess weight loss, respectively; 4.6 and 4.77 kg for overall and 3-month weight loss, respectively; and 2.81, 1.62, and 4.09 % for overall, 3-month, and >3-month percent of weight loss, respectively. A significant effect size was calculated that favored fluid-filled IGBs over air-filled IGBs. Flatulence (8.75 vs. 3.89 %, p = 0.0006), abdominal fullness (6.32 vs. 0.55 %, p = 0.001), abdominal pain (13.86 vs. 7.2 %, p = 0.0001), abdominal discomfort (4.37 vs. 0.55 %, p = 0.006), and gastric ulcer (12.5 vs. 1.2 %, p < 0.0001) were significantly more prevalent among IGB patients than among non-IGB control patients. No mortality was reported from IGB treatment. CONCLUSION IGB treatment, in addition to lifestyle modification, is an effective short-term modality for weight loss. However, there is not sufficient evidence confirming its safety or long-term efficacy.
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Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, de Mendonça LMC, de Godoy-Matos AF, Lopes AJ, Farias MLF. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes 2017; 15:211. [PMID: 29065923 PMCID: PMC5655862 DOI: 10.1186/s12955-017-0790-x] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2017] [Accepted: 10/16/2017] [Indexed: 02/02/2023] Open
Abstract
Background Obesity is a worldwide public health issue with a negative impact on quality of life. Different weight loss interventions have demonstrated improvements in quality of life. The aim of this study was to investigate the effect of 6 months of treatment with an intragastric balloon (IGB) on health-related quality of life (HRQOL) and its relation to changes in body fat in obese individuals with metabolic syndrome (MS). Methods Fifty obese patients with MS aged 18–50 were selected for treatment with IGB for 6 months. Body fat was assessed with anthropometric measures and dual-energy X-ray absorptiometry (DXA) at baseline and after removal of the IGB. HRQOL was evaluated with the short form of the World Health Organization Quality of Life (WHOQOL-BREF) at baseline and soon after removal of the IGB. Results Thirty-nine patients completed the study. After 6 months, there was a significant improvement in quality of life (p = 0.0009) and health (p < 0.0001) perceptions, and in the Physical (p = 0.001), Psychological (p = 0.031), and Environmental domains (p = 0.0071). Anthropometric measures and total fat determined by DXA were directly and significantly related to an improvement in general aspects of quality of life. The decrease in the percentage of total fat was the parameter that better correlated with improvements in quality of life perception after regression (p = 0.032). Conclusions In obese individuals with MS, weight loss parameters were associated with short-term improvements in HRQOL after 6 months of treatment with IGB. However, only total fat was independently related to HRQOL perception. Trial registration ClinicalTrials.gov NCT01598233.
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Affiliation(s)
- Erika Paniago Guedes
- Division of Metabology, State Institute of Diabetes and Endocrinology (IEDE), Avenida das Américas, 2901, sala 305, Barra da Tijuca, Rio de Janeiro, RJ, CEP 22631 001, Brazil. .,Division of Endocrinology, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
| | - Eduardo Madeira
- Division of Gastroenterology, State University of Rio de Janeiro, Rio de Janeiro, Brazil.,Division of Endocrinology, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
| | - Thiago Thomaz Mafort
- Division of Pneumology, State University of Rio de Janeiro, Rio de Janeiro, Brazil
| | - Miguel Madeira
- Division of Endocrinology, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
| | - Rodrigo Oliveira Moreira
- Division of Metabology, State Institute of Diabetes and Endocrinology (IEDE), Avenida das Américas, 2901, sala 305, Barra da Tijuca, Rio de Janeiro, RJ, CEP 22631 001, Brazil.,Division of Endocrinology, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
| | | | - Amélio Fernando de Godoy-Matos
- Division of Metabology, State Institute of Diabetes and Endocrinology (IEDE), Avenida das Américas, 2901, sala 305, Barra da Tijuca, Rio de Janeiro, RJ, CEP 22631 001, Brazil
| | - Agnaldo José Lopes
- Division of Pneumology, State University of Rio de Janeiro, Rio de Janeiro, Brazil
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Brazilian Intragastric Balloon Consensus Statement (BIBC): practical guidelines based on experience of over 40,000 cases. Surg Obes Relat Dis 2017; 14:151-159. [PMID: 29108896 DOI: 10.1016/j.soard.2017.09.528] [Citation(s) in RCA: 80] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2017] [Revised: 09/21/2017] [Accepted: 09/23/2017] [Indexed: 01/24/2023]
Abstract
BACKGROUND Intragastric balloons (IGBs) are a minimally invasive option for obesity treatment, acting as a space-occupying device and leading to weight loss through increased satiety. This device has been growing in popularity owing to its safety profile and good weight loss results. However, there are no published guidelines that standardize the technical aspects of the procedure. OBJECTIVES To create a practical guideline for intragastric balloon usage. SETTING Private and Academic Settings, Brazil. METHODS A consensus meeting was held in São Paulo, Brazil, in June 2016, bringing together 39 Brazilian endoscopists with extensive experience in IGBs from all regions of the country. Topics on patient selection, indications, contraindications, multidisciplinary follow-up, technique, and adverse events were discussed in the form of questions. After electronic voting, a consensus was defined when there was ≥70% agreement. Experts were also requested to provide data on their experience with IGBs. RESULTS The selected experts discussed and reached a consensus on 76 questions, mainly concerning specific indications and contraindications for the procedure; technical details, such as patient preparation, minimum balloon-filling volume, techniques for implant and explant; patient follow-up and recommended medication for the adaptation period; and adverse event management. The overall Brazilian expert data encompassed 41,863 IGBs, with a mean percentage total weight loss of 18.4% ± 2.9%. The adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation (.9%) and spontaneous deflation (.8%) of the device. The early removal rate due to intolerance was 2.2%. CONCLUSIONS The present consensus represents practical recommendations for performing IGB procedures and reflects Brazil's significant experience with this device. The experience of over 40,000 cases shows that the device leads to satisfactory weight loss with a low rate of adverse events.
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Abstract
Obesity is a major public health concern that leads to numerous metabolic, mechanical and psychological complications. Although lifestyle interventions are the cornerstone of obesity management, subsequent physiological neurohormonal adaptations limit weight loss, strongly favour weight regain and counteract sustained weight loss. A range of effective therapies are therefore needed to manage this chronic relapsing disease. Bariatric surgery delivers substantial, durable weight loss but limited access to care, perceived high risks and costs restrict uptake. Medical devices are uniquely positioned to bridge the gap between more conservative lifestyle intervention and weight-loss pharmacotherapy and more disruptive bariatric surgery. In this Review, we examine the range of gastrointestinal medical devices that are available in clinical practice to treat obesity, as well as those that are in advanced stages of development. We focus on the mechanisms of action as well as the efficacy and safety profiles of these devices. Many of these devices are placed endoscopically, which provides gastroenterologists with exciting opportunities for treatment.
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Raftopoulos I, Giannakou A. The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis 2017; 13:1174-1182. [DOI: 10.1016/j.soard.2017.02.016] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2016] [Revised: 02/14/2017] [Accepted: 02/16/2017] [Indexed: 01/27/2023]
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Klobucar Majanovic S, Brozovic B, Stimac D. Bariatric endoscopy: current state of the art, emerging technologies, and challenges. Expert Rev Med Devices 2017; 14:149-159. [PMID: 28081657 DOI: 10.1080/17434440.2017.1281741] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
Over the last few decades obesity has become a major health issue worldwide. Although dietary and lifestyle changes are the cornerstone of obesity management, it still poses a huge challenge for the majority of patients to permanently change their eating habits. Bariatric endoscopy represents an evolving filed of minimally invasive techniques and procedures for weight loss trying to respond to these challenges by developing new methods with the increasing role of endoscopists in the management of obesity. Areas covered: The aim of this article is to review the role and the advantages of bariatric endoscopy in the management of obesity by providing a comprehensive reference source and evaluating the currently available and emerging endoscopic devices and techniques for weight loss. Expert commentary: Endoscopic methods for weight loss represent a useful armamentarium in the management of obesity by providing improved effectiveness compared with medications, with a lower risk profile than traditional bariatric surgery. Although preliminary results of recently introduced methods are encouraging, many questions remain regarding the safety and efficacy of such interventions. Combining scientific background with advancements in technology is the key strategy for the further development of bariatric endoscopy.
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Affiliation(s)
- Sanja Klobucar Majanovic
- a Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolic Diseases , University Hospital Rijeka , Croatia , Rijeka
| | - Boris Brozovic
- b Department of Internal Medicine, Division of Gastroenterology , University Hospital Rijeka , Croatia , Rijeka
| | - Davor Stimac
- b Department of Internal Medicine, Division of Gastroenterology , University Hospital Rijeka , Croatia , Rijeka
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Do TN, Ho KY, Phee SJ. A Magnetic Soft Endoscopic Capsule-Inflated Intragastric Balloon for Weight Management. Sci Rep 2016; 6:39486. [PMID: 28000756 PMCID: PMC5175216 DOI: 10.1038/srep39486] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2016] [Accepted: 11/21/2016] [Indexed: 02/06/2023] Open
Abstract
Overweight and obesity have been identified as a cause of high risk diseases like diabetes and cancer. Although conventional Intragastric Balloons (IGBs) have become an efficient and less invasive method for overweight and obesity treatment, the use of conventional tools such as catheter or endoscope to insert and remove the IGBs from the patient's body causes nausea, vomiting, discomfort, and even gastric mucous damage. To eliminate these drawbacks, we develop a novel magnetic soft capsule device with gas-filled balloon inflation. The balloon is made from a thin and biocompatible material that can be inflated to a desired volume using biocompatible effervescent chemicals. In addition, both the outer balloon and inner capsule are designed to be soft and chemical resistance. The soft capsule shell is fabricated using scaffold-solvent approach while the outer balloon utilizes a novel fabrication approach for 3D spherical structure. A prototype of the proposed capsule and balloon is given. Experiments are successfully carried out in stimulated gastric environment and fresh porcine stomach to validate the effectiveness and reliability of the proposed approach.
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Affiliation(s)
- Thanh Nho Do
- California NanoSystems Institute (CNSI), University of California, Santa Barbara, Room 2810, Elings Hall, Mesa Road, CA, 93106, USA
| | - Khek Yu Ho
- Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore and National University of Health System, 119260 Singapore
| | - Soo Jay Phee
- School of Mechanical and Aerospace Engineering, Nanyang Technological University, 50 Nanyang Avenue, 639798 Singapore
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Short-term outcomes of the new intragastric balloon End-Ball ® for treatment of obesity. Wideochir Inne Tech Maloinwazyjne 2016; 11:229-235. [PMID: 28194241 PMCID: PMC5299079 DOI: 10.5114/wiitm.2016.63988] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2016] [Accepted: 10/19/2016] [Indexed: 12/23/2022] Open
Abstract
INTRODUCTION Intragastric balloons (IGBs) have been successfully used to treat obesity for the last 18 years. These balloons are made of different materials and filled with either air or saline. It seems that balloons filled with saline result in more effective weight loss, but are associated with worse tolerance after implantation. In contrast, balloons filled with air are associated with excellent tolerance, but result in less effective weight loss. AIM To report the early safety and effectiveness results of the End-Ball® balloon and to encourage discussions on how to best use this new-generation IGB for endoscopic weight loss management. MATERIAL AND METHODS Twenty obese patients (mean age: 40.5 years; mean body mass index: 34.8 kg/m2) were included in a 6-month study. Balloons were inflated with 300 ml of saline containing 5 ml of methylene blue and 300 cm3 of air. RESULTS No serious adverse events occurred during treatment. Patients experienced varying degrees of nausea, vomiting (mean: 3.7 times the first day), and abdominal pain after implantation. Six months (23-29 weeks) after End-Ball® balloon insertion, we observed a significant decrease in body weight (13.9 ±5.1 kg) and percent excess weight loss (37.9 ±12.9%). We also found a significant decrease in the levels of glycated hemoglobin (p < 0.001), C-peptide (p < 0.002), and triacylglycerols (p < 0.001) and an increase in the concentration of high-density lipoprotein cholesterol (p < 0.025). CONCLUSIONS The End-Ball® IGB is a safe and effective treatment for morbid obesity, with positive effects on weight loss and saccharide metabolism.
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Abstract
Obesity remains a tremendous public health, clinical, and scientific challenge globally. Conventional approaches in the management of obesity offer limited potential for sustained weight loss. Bariatric surgery, although it represents the most effective weight loss treatment, has its own risks and is associated with substantial costs and limited patient applicability. Endoscopic weight loss procedures are considered as the major breakthrough in the management of obesity. Endoluminal interventions performed entirely through the gastrointestinal tract have evolved as a result of an attempt to replicate some of the anatomical features and the physiological effects of the traditional weight loss surgery while being reversible, less invasive, and more cost-effective. Restrictive procedures act to decrease gastric volume by space-occupying devices and/or by suturing or stapling techniques that alter gastric anatomy, whereas malabsorptive procedures tend to create malabsorption by preventing food contact with the duodenum and proximal jejunum. Other procedures act by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve blocking) or by gastric aspiration. It is important to underline that the majority of endoscopic weight loss procedures are still being evaluated and are not yet available routinely. Even though some of the techniques and devices that have recently emerged have demonstrated promising short-term results, evidence on their safety and long-term efficacy from well-designed and well-conducted research should be given before they can become an inherent part of everyday clinical practice. Given the rapid development of endoscopic weight loss procedures, this review considers the current state and recent trends in endoscopic management of obesity.
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Kim SH, Chun HJ, Choi HS, Kim ES, Keum B, Jeen YT. Current status of intragastric balloon for obesity treatment. World J Gastroenterol 2016; 22:5495-5504. [PMID: 27350727 PMCID: PMC4917609 DOI: 10.3748/wjg.v22.i24.5495] [Citation(s) in RCA: 76] [Impact Index Per Article: 8.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/27/2016] [Revised: 04/28/2016] [Accepted: 05/23/2016] [Indexed: 02/06/2023] Open
Abstract
Endoscopic bariatric therapy may be a useful alternative to pharmacological treatment for obesity, and it provides greater efficacy with lower risks than do conventional surgical procedures. Among the various endoscopic treatments for obesity, the intragastric balloon is associated with significant efficacy in body weight reduction and relief of comorbid disease symptoms. Anatomically, this treatment is based on gastric space-occupying effects that increase the feeling of satiety and may also affect gut neuroendocrine signaling. The simplicity of the intragastric balloon procedure may account for its widespread role in obesity treatment and its applicability to various degrees of obesity. However, advances in device properties and procedural techniques are still needed in order to improve its safety and cost-effectiveness. Furthermore, verification of the physiological outcomes of intragastric balloon treatment and the clinical predictive factors for treatment responses should be considered. In this article, we discuss the types, efficacy, safety, and future directions of intragastric balloon treatment.
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Ali MR, Moustarah F, Kim JJ. American Society for Metabolic and Bariatric Surgery position statement on intragastric balloon therapy endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons. Surg Obes Relat Dis 2016; 12:462-467. [DOI: 10.1016/j.soard.2015.12.026] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2015] [Accepted: 12/18/2015] [Indexed: 12/16/2022]
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Moura D, Oliveira J, De Moura EGH, Bernardo W, Galvão Neto M, Campos J, Popov VB, Thompson C. Effectiveness of intragastric balloon for obesity: A systematic review and meta-analysis based on randomized control trials. Surg Obes Relat Dis 2016; 12:420-429. [PMID: 26968503 DOI: 10.1016/j.soard.2015.10.077] [Citation(s) in RCA: 77] [Impact Index Per Article: 8.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2015] [Revised: 10/14/2015] [Accepted: 10/16/2015] [Indexed: 02/06/2023]
Abstract
BACKGROUND Obesity has become a worldwide epidemic, and many methods are currently used to reduce obesity. This systematic review shows the effectiveness of the intragastric balloon (IGB) method compared to the sham/diet (s/d) method. OBJECTIVE To demonstrate the effectiveness of the IGB method compared to the s/d method. SETTING Hospital das Clinicas da Universidade de São Paulo, Brazil, Public Hospital. METHODS After searching MEDLINE, Embase, Cochrane, Lilacs, Scopus, and CINAHL, only enrolled randomized control trials comparing IGB/diet with s/d were analyzed. For qualitative analysis, 12 studies were selected, and 9 of these were acceptable for quantitative analysis. RESULTS The IGB/diet is more effective than s/d when comparing body mass index (BMI) loss with a mean difference of 1.1 kg/m(2) by the Student's t test and 1.41 kg/m(2) by the meta-analysis, with significant differences in both. It is also more effective in weight loss (WL), with a mean difference of 2 kg by the Student's t test and 3.55 kg by the meta-analysis. In the qualitative analysis of % excess WL (%EWL), the mean %EWL is 14.0% in favor of the IGB group compared to the s/d group by the Student's t test; however, no significant difference was found between these groups by quantitative analysis. CONCLUSION Based on randomized control trial data alone, IGB>400 mL is more effective than sham/diet in achieving BMI loss, WL, and %EWL.
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Affiliation(s)
- Diogo Moura
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.
| | - Joel Oliveira
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil
| | - Eduardo G H De Moura
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil
| | - Wanderlei Bernardo
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil
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Gleysteen JJ. A history of intragastric balloons. Surg Obes Relat Dis 2015; 12:430-5. [PMID: 26775045 DOI: 10.1016/j.soard.2015.10.074] [Citation(s) in RCA: 62] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2015] [Revised: 10/08/2015] [Accepted: 10/13/2015] [Indexed: 02/06/2023]
Abstract
The history of intragastric balloons (IGBs) began in 1985 with the Garren-Edwards Bubble. It was approved by the U.S. Food and Drug Administration (FDA) for temporary use as a weight loss device, but its manufacture was discontinued in 1988, and approval was withdrawn in 1992 because of significant complications and limited and recidivistic weight loss. A number of IGBs have appeared since that time, mostly originating in Europe or South America, but none has acquired FDA approval until recently; the ReShape Duo Integrated Dual Balloon System (ReShape Medical Inc., San Clemente, California) received FDA approval in August 2015. The conclusions of an important 1987 international conference on IGBs and the characteristics, effectiveness, and problems of most other IGBs are described in this text. The common purpose of these devices as preliminary interventions before gastric bariatric surgery and their favorable effects on this purpose are emphasized and may have played a key role in the FDA's change of outlook of the IGB.
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Affiliation(s)
- John J Gleysteen
- Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
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Tolerance of intragastric balloon and patient's satisfaction in obesity treatment. Wideochir Inne Tech Maloinwazyjne 2015; 10:445-9. [PMID: 26649094 PMCID: PMC4653252 DOI: 10.5114/wiitm.2015.54047] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2015] [Revised: 07/09/2015] [Accepted: 07/22/2015] [Indexed: 01/14/2023] Open
Abstract
Introduction The dietary management of obesity is associated with a high failure rate. Methods which enable the long-term reduction of food intake have been developed. Patients treated with an intragastric balloon may experience some unwanted symptoms during therapy. The severity of these symptoms may result in poor tolerance of treatment, while patients who do not experience these symptoms may refuse to follow dietary modifications. In these cases, weight reduction at the end of treatment may be below expectations. Aim To assess the tolerance of intragastric balloon treatment in obese patients as well as their satisfaction with this treatment. Material and methods Fifty-seven gastric balloon procedures were performed in 51 females and 6 males aged 17 to 65 years (39.5 ±10.7 years). Baseline weight was 104 ±14.5 kg (78–140 kg), body mass index 37.2 ±4.1 kg/m2 (29.8–48.1 kg/m2), mean excess body weight 41.2 ±11.5 kg (20.4–63.1 kg). The balloon was filled with 669 ±25.8 ml of saline solution (550–700 ml). Upon balloon removal 6 months later, the patients completed a 12-question survey. Results We obtained 57 surveys. The most common symptoms included vomiting, heartburn, abdominal pain and others. Twenty-two patients reported > 2 symptoms. Two patients were symptom-free. The mean duration of symptoms was 24.8 days. Patients reported better control of hypertension, diabetes and resolution of obstructive sleep apnoea and joint symptoms. Only 14 patients did not observe any significant improvement in their bodily function. Fifty-four patients expressed satisfaction after treatment, 6 patients were dissatisfied with the weight loss, and 5 patients would not opt for balloon re-treatment. Conclusions The balloon treatment is a safe and well-tolerated therapy with a low complication rate.
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ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc 2015; 82:425-38.e5. [PMID: 26232362 DOI: 10.1016/j.gie.2015.03.1964] [Citation(s) in RCA: 285] [Impact Index Per Article: 28.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2015] [Accepted: 03/17/2015] [Indexed: 02/08/2023]
Abstract
The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.
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Lindekilde N, Gladstone BP, Lübeck M, Nielsen J, Clausen L, Vach W, Jones A. The impact of bariatric surgery on quality of life: a systematic review and meta-analysis. Obes Rev 2015; 16:639-51. [PMID: 26094664 DOI: 10.1111/obr.12294] [Citation(s) in RCA: 136] [Impact Index Per Article: 13.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2015] [Revised: 04/28/2015] [Accepted: 04/30/2015] [Indexed: 12/13/2022]
Abstract
This study aims to review the obesity literature in order to assess the impact of bariatric surgery on quality of life and the between-study variation by examining the standardized mean magnitude of effect in change in the levels of quality of life. The following databases EMBASE, PubMed, PsycINFO, CINAHL, the Cochrane Library and Web of Science were systematically searched for studies examining change in quality of life in adults receiving bariatric surgery for obesity. Seventy-two studies were included with a total of 9,433 participants treated for obesity with bariatric surgery. The average impact of bariatric surgery on quality of life corresponded to an effect size of 0.88 (95% CI: 0.80-0.96), indicating that bariatric surgery has a significant positive influence on quality of life in general. The impact varied considerably across studies with bariatric surgery showing a significantly greater positive influence on physical quality of life compared to mental quality of life. Bariatric surgery is effective in improving quality of life, especially when looking at physical well-being. Greater focus on the psychological well-being of the person undergoing surgery for obesity may lead to a better post-surgery prognosis for more people.
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Affiliation(s)
- N Lindekilde
- Institute of Psychology, University of Southern Denmark, Odense, Denmark
| | - B P Gladstone
- Institute of Medical Biometry and Medical Informatics, University Medical Centre Freiburg, Freiburg im Breisgau, Germany
| | - M Lübeck
- Institute of Psychology, University of Southern Denmark, Odense, Denmark
| | - J Nielsen
- Institute of Psychology, University of Southern Denmark, Odense, Denmark
| | - L Clausen
- Centre of Child- and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark
| | - W Vach
- Institute of Medical Biometry and Medical Informatics, University Medical Centre Freiburg, Freiburg im Breisgau, Germany
| | - A Jones
- Institute of Psychology, University of Southern Denmark, Odense, Denmark
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Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months. Surg Endosc 2014; 29:2339-43. [PMID: 25480604 DOI: 10.1007/s00464-014-3957-0] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2013] [Accepted: 10/24/2014] [Indexed: 02/08/2023]
Abstract
BACKGROUND Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.
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Mathus-Vliegen EMH. Endoscopic treatment: the past, the present and the future. Best Pract Res Clin Gastroenterol 2014; 28:685-702. [PMID: 25194184 DOI: 10.1016/j.bpg.2014.07.009] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2014] [Revised: 06/21/2014] [Accepted: 07/05/2014] [Indexed: 02/07/2023]
Abstract
The obesity epidemic asks for an active involvement of gastroenterologists: many of the co-morbidities associated with obesity involve the gastrointestinal tract; a small proportion of obese patients will need bariatric surgery and may suffer from surgical complications that may be solved by minimally invasive endoscopic techniques; and finally, the majority will not be eligible for bariatric surgery and will need some other form of treatment. The first approach should consist of an energy-restricted diet, physical exercise and behaviour modification, followed by pharmacotherapy. For patients who do not respond to medical therapy but are not or not yet surgical candidates, an endoscopic treatment might look attractive. So, endoscopic bariatric therapy has a role to play either as an alternative or adjunct to medical treatment. The different endoscopic modalities may vary in mechanisms of action: by gastric distension and space occupation, delayed gastric emptying, gastric restriction and decreased distensibility, impaired gastric accommodation, stimulation of antroduodenal receptors, or by duodenal exclusion and malabsorption. These treatments will be discussed into detail.
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Affiliation(s)
- E M H Mathus-Vliegen
- Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
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Effect of Intragastric Balloon on Gastric Emptying Time in Humans for Weight Control. Clin Nucl Med 2013; 38:863-8. [DOI: 10.1097/rlu.0000000000000224] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/22/2023]
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Caglar E, Dobrucali A, Bal K. Gastric balloon to treat obesity: filled with air or fluid? Dig Endosc 2013; 25:502-507. [PMID: 23369002 DOI: 10.1111/den.12021] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2012] [Accepted: 11/09/2012] [Indexed: 12/24/2022]
Abstract
BACKGROUND Our aim was to study the efficacy and safety of different types of intragastric balloon in morbidly obese patients. PATIENTS AND METHODS From 2005 to 2011, intragastric balloons were inserted endoscopically into 32 patients. Intragastric balloons were used in morbidly obese (body mass index [BMI] ≥ 35 kg/m(2) ) individuals who were non-responsive to 6-month medical therapy and diet. Balloons were endoscopically removed after 6 months. RESULTS Thirty-six balloons were inserted in a total of 32 patients. Mean age of the patients was 37.28 ± 12.08 (17-64) years and mean height was 169.81 ± 8.17 (150-185) cm. Initial mean weight was 128.87 ± 23.31 kg and BMI was 45.26 ± 8.48 kg/m(2) . At month 6, mean bodyweight was 116.93 ± 23.18 and BMI was 40.96 ± 7.96 kg/m(2) (P < 0.001, P < 0.001, respectively). At the end of 6 months, while the excessweight loss (EWL) median was 13.0 kg, [interquartile range IQR: 5.0-16.0] and percent EWL median was 21.92, [IQR: 12.72-28.49] in the Heliosphere BAG patients, the EWL median was 19.0 kg, [IQR: 14.47-26.72] and the percent EWL median was 38.26, [IQR: 19.73-47.79] in the BioEnterics Intragastric Balloon patients (P = 0.006, P = 0.010, respectively for EWL median and percent EWL median). One patient died (3.1%) of cardiac arrest due to aspiration at day 13 after BIB placement. CONCLUSION Although not without risk, intragastric balloon placement is an effective method for weight loss. BioEnterics Intragastric Balloon is more effective in helping weight loss than the Heliosphere BAG balloon.
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Affiliation(s)
- Erkan Caglar
- Gastroenterology Department, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey.
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Abstract
BACKGROUND The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance. METHODS Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon-BIB; n = 30; 20 F/10 M, mean age 36.7 ± 10.9; mean BMI 46.5 ± 5.9) and group B (Endobag-Heliosphere; n = 30; 20 F/10 M, mean age 37.8 ± 10.6; mean BMI 46.1 ± 5.6). All patients of both groups were sedated with midazolam (5 mg) + Propofol (2 mg/kg i.v.). The Heliosphere Bag was air-filled with 950 ml while BIB® was inflated with 500 ml of saline and 10 ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and χ(2) test were used for statistical analysis. RESULTS Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8 ± 6.2 and 41.9 ± 6.5(p = ns), and mean %EWL was 20 ± 12 and 18 ± 14 (p = ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx. CONCLUSIONS Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.
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