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Morales-Conde S, Peeters A, Meyer YM, Antoniou SA, Del Agua IA, Arezzo A, Arolfo S, Yehuda AB, Boni L, Cassinotti E, Dapri G, Yang T, Fransen S, Forgione A, Hajibandeh S, Hajibandeh S, Mazzola M, Migliore M, Mittermair C, Mittermair D, Morandeira-Rivas A, Moreno-Sanz C, Morlacchi A, Nizri E, Nuijts M, Raakow J, Sánchez-Margallo FM, Sánchez-Margallo JA, Szold A, Weiss H, Weiss M, Zorron R, Bouvy ND. European association for endoscopic surgery (EAES) consensus statement on single-incision endoscopic surgery. Surg Endosc 2019; 33:996-1019. [PMID: 30771069 PMCID: PMC6430755 DOI: 10.1007/s00464-019-06693-2] [Citation(s) in RCA: 38] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2019] [Accepted: 02/06/2019] [Indexed: 12/14/2022]
Abstract
BACKGROUND Laparoscopic surgery changed the management of numerous surgical conditions. It was associated with many advantages over open surgery, such as decreased postoperative pain, faster recovery, shorter hospital stay and excellent cosmesis. Since two decades single-incision endoscopic surgery (SIES) was introduced to the surgical community. SIES could possibly result in even better postoperative outcomes than multi-port laparoscopic surgery, especially concerning cosmetic outcomes and pain. However, the single-incision surgical procedure is associated with quite some challenges. METHODS An expert panel of surgeons has been selected and invited to participate in the preparation of the material for a consensus meeting on the topic SIES, which was held during the EAES congress in Frankfurt, June 16, 2017. The material presented during the consensus meeting was based on evidence identified through a systematic search of literature according to a pre-specified protocol. Three main topics with respect to SIES have been identified by the panel: (1) General, (2) Organ specific, (3) New development. Within each of these topics, subcategories have been defined. Evidence was graded according to the Oxford 2011 Levels of Evidence. Recommendations were made according to the GRADE criteria. RESULTS In general, there is a lack of high level evidence and a lack of long-term follow-up in the field of single-incision endoscopic surgery. In selected patients, the single-incision approach seems to be safe and effective in terms of perioperative morbidity. Satisfaction with cosmesis has been established to be the main advantage of the single-incision approach. Less pain after single-incision approach compared to conventional laparoscopy seems to be considered an advantage, although it has not been consistently demonstrated across studies. CONCLUSIONS Considering the increased direct costs (devices, instruments and operating time) of the SIES procedure and the prolonged learning curve, wider acceptance of the procedure should be supported only after demonstration of clear benefits.
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Affiliation(s)
- Salvador Morales-Conde
- Unit of Innovation in Minimally Invasive Sugery, Department of General and Digestive Surgery, University Hospital "Virgen del Rocio", Sevilla, Spain
| | - Andrea Peeters
- Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Yannick M Meyer
- Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
| | - Stavros A Antoniou
- Colorectal Department, Royal Devon & Exeter NHS Foundation Trust, Exeter, UK
| | - Isaías Alarcón Del Agua
- Unit of Innovation in Minimally Invasive Sugery, Department of General and Digestive Surgery, University Hospital "Virgen del Rocio", Sevilla, Spain
| | - Alberto Arezzo
- Department of Surgical Sciences, University of Torino, Torino, Italy
| | - Simone Arolfo
- Department of Surgical Sciences, University of Torino, Torino, Italy
| | - Amir Ben Yehuda
- Surgery division, Assaf Harofe medical center, Zeriffin, Israel
| | - Luigi Boni
- Department of Surgery, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
| | - Elisa Cassinotti
- Department of Surgery, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
| | | | - Tao Yang
- Unit of Innovation in Minimally Invasive Sugery, Department of General and Digestive Surgery, University Hospital "Virgen del Rocio", Sevilla, Spain
| | - Sofie Fransen
- Department of Surgery, Laurentius Ziekenhuis Roermond, Roermond, The Netherlands
| | | | | | - Shahin Hajibandeh
- Department of General Surgery, Stepping Hill Hospital, Stockport, UK
| | | | - Marco Migliore
- Department of Surgical Sciences, University of Torino, Torino, Italy
| | | | | | - Antonio Morandeira-Rivas
- Department of Surgery, "La Mancha Centro" General Hospital, Alcázar de San Juan, Ciudad Real, Spain
| | - Carlos Moreno-Sanz
- Department of Surgery, "La Mancha Centro" General Hospital, Alcázar de San Juan, Ciudad Real, Spain
| | | | - Eran Nizri
- Surgery division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
| | - Myrthe Nuijts
- Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Jonas Raakow
- Center for Innovative Surgery- ZIC, Charité - Universitätsmedizin, Chirurgische Klinik, Campus Charité Mitte/ Campus Virchow-Klinikum, Berlin, Germany
| | | | | | | | - Helmut Weiss
- SJOG Hospital - PMU Teaching Hospital, Salzburg, Austria
| | - Michael Weiss
- SJOG Hospital - PMU Teaching Hospital, Salzburg, Austria
| | - Ricardo Zorron
- Department of Surgery, University of Insubria, Varese, Italy
| | - Nicole D Bouvy
- Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
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Bulian DR, Knuth J, Lehmann KS, Sauerwald A, Heiss MM. Systematic analysis of the safety and benefits of transvaginal hybrid-NOTES cholecystectomy. World J Gastroenterol 2015; 21:10915-10925. [PMID: 26478683 PMCID: PMC4600593 DOI: 10.3748/wjg.v21.i38.10915] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2015] [Revised: 07/21/2015] [Accepted: 09/14/2015] [Indexed: 02/06/2023] Open
Abstract
AIM: To evaluate transvaginal hybrid-NOTES cholecystectomy (TVC) during its clinical establishment and compare it with the traditional laparoscopic technique (LC).
METHODS: The specific problems and benefits of TVC were reviewed using a registry analysis, a comparative cohort study and a randomized clinical trial. At first, feasibility, safety and specific complications of the TVC were analyzed based on the first 488 data sets of the German NOTES Registry (GNR). Hereafter, we compared the early postoperative results of our first 50 TVC-patients with those of 50 female LC-patients matched by age, BMI and ASA classification. The same cohort was contacted an average of two years later to evaluate long-term results concerning pain and satisfaction with the aesthetic results and the overall postoperative results as well as sexual intercourse by means of two domains of the German version of the Female Sexual Function Index (FSFI-d). Consequently, we performed a randomized clinical trial comparing 20 TVC-patients with 20 needlescopic/3-trocar cholecystectomies (NC) also concerning the early postoperative results as well as pain, satisfaction and quality of life by means of the Eypasch Gastrointestinal Quality of Life Index (GIQLI) in the later course. Finally, we discussed the results in accordance with other published studies.
RESULTS: The complication (3.5%) and conversion rates (4.1%) for TVC were low in the GNR and comparable to those of the LC. Access related intraoperative complications included injuries to the bladder (n = 4; 0.8%) and bowel (n = 3; 0.6%). The study cohort revealed less postoperative pain after TVC comparing to the LC-patients on the day of surgery (NRS, 1.5/10 vs 3.1/10, P = 0.003), in the morning (NRS, 1.9/10 vs 2.8/10, P = 0.047) and in the evening (NRS, 1.1/10 vs 1.8/10, P = 0.025) of postoperative day (POD) one. The randomized clinical trial consistently found less cumulative pain until POD 2 (NRS, 8/40 vs 14/40, P = 0.043), as well as until POD 10 (NRS, 22/190 vs 41/190, P = 0.010). Furthermore, the TVC-patients had a better quality of life on POD 10 than did the LC-patients (GIQLI, 124/144 vs 107/144, P = 0.028). The complication rates were comparable and no specific problems were detected in the long-term follow-up for sexual intercourse for either group. The TVC-patients were more satisfied with the aesthetic result in the long-term course in the matched cohort analysis (1.00 vs 1.88, P < 0.001) as well as in the randomized clinical trial (1.00 vs 1.70, P < 0.001) when compared with the LC-patients.
CONCLUSION: TVC is a feasible procedure with a high safety profile and has advantages in regard to postoperative pain and aesthetic results when compared with LC or NC.
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