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Wakasa J, Iwakiri K, Ohta Y, Minoda Y, Kobayashi A, Nakamura H. Perioperative bleeding control in total hip arthroplasty: hemostatic powder vs. tranexamic acid-a prospective randomized controlled trial. Arch Orthop Trauma Surg 2024; 144:3797-3805. [PMID: 39105837 DOI: 10.1007/s00402-024-05475-3] [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] [Received: 03/06/2024] [Accepted: 07/23/2024] [Indexed: 08/07/2024]
Abstract
BACKGROUND Perioperative bleeding in total hip arthroplasty (THA) can lead to various problems, so effective management of blood loss is needed. This prospective, single-blind, randomized controlled trial aimed to compare the efficacy of topical administration of SURGICEL® (a hemostatic agent of oxidized regenerated cellulose) powder (SP) and tranexamic acid (TXA) in controlling perioperative bleeding during THA. MATERIALS AND METHODS In total, 114 patients undergoing THA for osteoarthritis were randomized to either group S (THA with SP) or group T (THA with TXA). Data including patient demographics, laboratory data (C-reactive protein [CRP], hemoglobin, and hematocrit), operative time, and intraoperative blood loss were analyzed. Clinical outcomes were assessed using WOMAC, JOA, FJS scores, and visual analog scale (VAS) scores. Primary outcomes were estimated total and postoperative blood loss, while secondary outcomes included hematological test results and various clinical scores. RESULTS 57 patients were allocated to each group, with 55 in group S and 56 in group T were finally included in the analysis. There was no significant difference (p = 0.141) in estimated total blood loss between group S (788.2 ± 350.1 ml) and group T (714.1 ± 318.4 ml). Hemoglobin and hematocrit levels and WOMAC, and FJS scores were not significantly different between the two groups at any time point. CRP levels were significantly different on postoperative days 4 and 7, and JOA score was significantly different on preoperative and postoperative period. However, the differences in CRP and JOA score values themselves were relatively small and not clinically different. CONCLUSIONS Topical administration of SP is as effective as TXA in reducing perioperative bleeding in patients undergoing THA. Additionally, no significant difference was observed in early postoperative clinical outcomes between SP and TXA. LEVEL OF EVIDENCE Therapeutic Level I. TRIAL REGISTRATION The University Hospital Medical Information Network (UMIN) registration number UMIN000047607.
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Affiliation(s)
- Jun Wakasa
- Department of Orthopaedic Surgery, Shiraniwa Hospital Joint Arthroplasty Center, 6-10-1 Shiraniwadai Ikoma, Nara, 630-0136, Japan
| | - Kentaro Iwakiri
- Department of Orthopaedic Surgery, Shiraniwa Hospital Joint Arthroplasty Center, 6-10-1 Shiraniwadai Ikoma, Nara, 630-0136, Japan.
| | - Yoichi Ohta
- Department of Orthopaedic Surgery, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka, 545-8585, Japan
| | - Yukihide Minoda
- Department of Orthopaedic Surgery, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka, 545-8585, Japan
| | - Akio Kobayashi
- Department of Orthopaedic Surgery, Shiraniwa Hospital Joint Arthroplasty Center, 6-10-1 Shiraniwadai Ikoma, Nara, 630-0136, Japan
| | - Hiroaki Nakamura
- Department of Orthopaedic Surgery, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka, 545-8585, Japan
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Masoudi M, Wiseman J, Wiseman SM. A contemporary systematic review of the complications associated with SURGICEL. Expert Rev Med Devices 2023; 20:741-752. [PMID: 37526076 DOI: 10.1080/17434440.2023.2242776] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2023] [Accepted: 07/27/2023] [Indexed: 08/02/2023]
Abstract
BACKGROUND This review aims to summarize the findings from recent literature (2010-2022) reporting on complications that resulted from the surgical use of SURGICEL for intraoperative hemostasis. METHODS A literature search was conducted using the MEDLINE (OVID), Embase, and Cochrane Central Register of Controlled Trials - CENTRAL (OVID) databases. The studies were sorted into case reports and other study types for data extraction. Covidence was used for data extraction and statistics were descriptive. RESULTS Of the total 560 articles screened, 73 papers were selected for a full-text review and 70 studies were included in this review. A total of 7,242 participants were included in the studies (case studies n = 93, others n = 7149). 67/70 of the included studies reported complications when SURGICEL was used intraoperatively. Reported complications included: SURGICEL induced masses (granulomas, abscesses, hematomas, cysts) (n = 25), hemorrhagic complications (n = 12), masses misdiagnosed as tumors, cardiovascular, nervous system, and hepatobiliary complications, pain, and infections. Other complications included: fistulas, erectile dysfunction, chorioamnionitis, swelling, urinary leak, renal failure, and anaphylaxis. CONCLUSIONS Publications reporting on complications associated with the use of SURGICEL intraoperatively have continued to emerge. Future studies should compare how the types and rates of complications compare between SURGICEL and alternative hemostatic agents.
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Affiliation(s)
- Matthew Masoudi
- Department of Surgery, St. Paul's Hospital & University of British Columbia, Vancouver, British Columbia, Canada
| | - Jacob Wiseman
- Department of Surgery, St. Paul's Hospital & University of British Columbia, Vancouver, British Columbia, Canada
| | - Sam M Wiseman
- Department of Surgery, St. Paul's Hospital & University of British Columbia, Vancouver, British Columbia, Canada
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Kazemi R, Gholipour F, Salehi H, Sichani MM, Behnamfar A, Fathi M. Evaluation of the efficacy of oxidized cellulose (surgicel) in reducing blood loss in suprapubic simple open prostatectomy: A randomized clinical trial. JOURNAL OF RESEARCH IN MEDICAL SCIENCES : THE OFFICIAL JOURNAL OF ISFAHAN UNIVERSITY OF MEDICAL SCIENCES 2023; 28:29. [PMID: 37213452 PMCID: PMC10199368 DOI: 10.4103/jrms.jrms_618_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/25/2022] [Revised: 10/03/2022] [Accepted: 10/27/2022] [Indexed: 05/23/2023]
Abstract
Background Simple open prostatectomy is still the treatment of choice for removing large prostates; however, peri-surgical bleeding accompanied by this technique has always been a challenge for urologist surgeons. Therefore, the present study aimed to investigate the effect of surgicel on reducing bleeding in trans-vesical prostatectomy. Materials and Methods The present double-blinded clinical trial included 54 patients with Benign Prostatic Hyperplasia (BPH), divided into two groups of 27, and underwent trans-vesical prostatectomy. After removing the prostate, the prostate adenoma was weighed in the first group. Then, two surgicel were inserted into the prostate loge for prostate adenomas weighing 75 g or less. For larger prostates, another surgicel was inserted for each 25 g weight higher than the limit of 75 g. However, no Surgicel was inserted in the control group. Other steps of the procedure were the same in both groups. Moreover, hemoglobin and hematocrit levels were assessed in both groups; preoperation, intra-operative, 24 h, and 48 h postoperative. In addition, all the fluid used for bladder irrigation was collected, and its hemoglobin level was assessed. Results According to our results, no intergroup difference in hemoglobin level changes, hematocrit changes, International Prostate Symptom Score (IPSS), postoperative hospital stay, and number of packed cells received. However, the postoperative blood loss in bladder lavage fluid was significantly higher in the control group (120.83 ± 46.66 g) as compared to the surgicel group (72.56 ± 32.53 g) (P < 0.001). Conclusion The present study concluded that using surgicel in trans-vesical prostatectomy could reduce postoperative bleeding without increasing the chance of postoperative complications.
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Affiliation(s)
- Reza Kazemi
- Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Farshad Gholipour
- Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Hanieh Salehi
- Urology Department, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
| | | | - Amir Behnamfar
- Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Majid Fathi
- Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
- Address for correspondence: Dr. Majid Fathi, Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. E-mail:
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Zhao X, Cai XZ, Wang W, Wu HB, Wu LD, Ye ZM, Yan SG. MAKO robotic assisted total hip replacement (THR) for patients with fused hips. Int J Med Robot 2022; 18:e2369. [PMID: 35060271 DOI: 10.1002/rcs.2369] [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: 11/15/2021] [Revised: 12/20/2021] [Accepted: 01/11/2022] [Indexed: 11/06/2022]
Abstract
BACKGROUND Previous articles about MAKO robotic-assisted total hip replacement (THR) were mainly in patients with comparatively normal anatomy. METHODS From July 2020 to June 2021, we performed MAKO robotic-assisted THR in three hip-fused patients. We assessed the accuracy of prostheses implantation, collected clinical data, and discussed the value of this technique in this kind of patients. RESULT All three patients achieved good leg length and prostheses position. A patient got femoral artery injury during the surgery. Moreover, she developed a thrombus. All three patients got acceptable Visual Analogue Scale scores and function recovery 6 months later. CONCLUSION MAKO robotic-assisted THR achieved excellent prosthesis position in hip fused patients. More cases are needed to confirm this advantage. The function recovery was acceptable. Caution should be paid to protect the surrounding abnormal arteries, especially in a limited surgical field.
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Affiliation(s)
- Xiang Zhao
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
| | - Xun-Zi Cai
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
| | - Wei Wang
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
| | - Hao-Bo Wu
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
| | - Li-Dong Wu
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
| | - Zhao-Ming Ye
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
| | - Shi-Gui Yan
- Department of Orthopaedics, the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU), Hangzhou, China.,Department of Orthopaedics, Research Institute of Zhejiang University, Hangzhou, China
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Lorenzo-Zúñiga V, Bustamante-Balén M, Pons-Beltrán V. Prevention of late complications with coverage agents in endoscopic resection of colorectal lesions: Current landscape in gastrointestinal endoscopy. World J Gastroenterol 2021; 27:1563-1568. [PMID: 33958843 PMCID: PMC8058649 DOI: 10.3748/wjg.v27.i15.1563] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/27/2020] [Revised: 02/05/2021] [Accepted: 03/09/2021] [Indexed: 02/06/2023] Open
Abstract
Endoscopic removal of large (≥ 20 mm) non-pedunculated colorectal lesions (LNPCLs) may result in major adverse events, such as delayed bleeding (DB) and delayed perforation (DP), despite closure of the mucosal defects with clips. Topical application of a coverage agent refers to the creation of a shield with a biocompatible medical device (tissue or hydrogel) with proven bioactive properties. Coverage of the eschar after endoscopic resection provides shielding protection to prevent delayed complications. The aim of the present review was to systematically collect and review the currently available literature regarding the prevention of DB and DP with coverage agents after endoscopic mucosal resection or endoscopic submucosal dissection of LNPCLs.
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Affiliation(s)
- Vicente Lorenzo-Zúñiga
- Endoscopy Unit, Department of Gastroenterology, Hospital Universitari i Politècnic La Fe, Valencia 46026, Spain
| | | | - Vicente Pons-Beltrán
- Digestive Diseases Department, La Fe Polytechnic University Hospital, Valencia 46026, Spain
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MacDonald MH, Tasse L, Wang D, Zhang G, De Leon H, Kocharian R. Evaluation of the Hemostatic Efficacy of Two Powdered Topical Absorbable Hemostats Using a Porcine Liver Abrasion Model of Mild to Moderate Bleeding. J INVEST SURG 2020; 34:1198-1206. [PMID: 32928005 DOI: 10.1080/08941939.2020.1792007] [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: 10/23/2022]
Abstract
INTRODUCTION Topical hemostatic agents, used alone or in combination, have become common adjuncts to manage tissue and organ bleeding resulting from trauma and surgical procedures. Oxidized regenerated cellulose (ORC) is one of the most commonly used adjunctive hemostatic agents. The aim of the present study was to compare the hemostatic efficacy of a novel ORC-based product, SURGICEL® Powder Absorbable Hemostat (Surgicel-P) to that of HEMOBLAST™ Bellows (Hemoblast-B), a collagen-based combination powder. METHODS Using an established porcine liver abrasion model, we randomly tested Surgicel-P and Hemoblast-B in 60 experimental lesion sites (30 per product tested). Primary endpoints included hemostatic efficacy measured by absolute time to hemostasis (TTH) within 5 minutes. We also examined number of applications required to achieve hemostasis, and sustained hemostasis following saline irrigation of test sites that achieved hemostasis. RESULTS Surgicel-P demonstrated significantly higher hemostatic efficacy and lower TTH (p < 0.01) than Hemoblast-B. Surgicel-P-treated lesion sites achieved hemostasis in 73.3% of cases following one product application vs. 3.3% of Hemoblast-B-treated sites. Of all sites that were assessed, hemostasis was achieved and sustained following irrigation at 93.3% of Surgicel-P-treated sites vs. 50.0% of Hemoblast-B-treated sites. The average number of Surgicel-P applications per site was 51% lower than the average number of applications used for Hemoblast-B. CONCLUSION Surgicel-P provided more effective and sustained hemostasis and faster TTH than Hemoblast-B. Surgicel-P represents a novel clinical alternative to provide adjunctive control of diffuse mild and moderate bleeding. Surgicel-P combines an ORC powder formulation and a delivery system in a device that is particularly useful for application on large surfaces and difficult-to-access anatomical locations where application of other forms of topical hemostats may be impractical.
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Affiliation(s)
| | | | - Daidong Wang
- Cardiovascular and Specialty Solutions (CSS), Irvine, California, USA
| | - Gary Zhang
- Ethicon, Inc, Johnson & Johnson, Somerville, New Jersey, USA
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Zimmer V. Endoscopic shielding using oxidized regenerated cellulose after argon plasma coagulation under mandatory dual antiplatelet therapy. JGH Open 2019; 3:344-345. [PMID: 31406929 PMCID: PMC6684507 DOI: 10.1002/jgh3.12135] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2018] [Revised: 12/01/2018] [Accepted: 12/13/2018] [Indexed: 01/28/2023]
Abstract
Endoscopic shielding is an innovative concept in therapeutic endoscopy. Its usage has been mostly restricted to wide‐field endoscopic mucosal resection and/or endoscopic submucosal dissection. A novel potential clinical use may be in bleeding pophylaxis for argon plasma coagulation‐related ulcers under concomitant mandatory dual antiplatelet therapy.
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Affiliation(s)
- Vincent Zimmer
- Department of Medicine Marienhausklinik St. Josef Kohlhof Neunkirchen Germany
- Department of Medicine II, Saarland University Medical Center Saarland University Homburg Germany
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Park JW, Kim JI, Bae SR, Lee YS, Han CH, Kang SH, Park BH. Hemostatic effect and psychological impact of an oxidized regenerated cellulose patch after transrectal ultrasound-guided prostate biopsy: A prospective and retrospective study. Medicine (Baltimore) 2019; 98:e15623. [PMID: 31096472 PMCID: PMC6531163 DOI: 10.1097/md.0000000000015623] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
To investigate the usefulness of the oxidized regenerated cellulose patch (ORCP) for postbiopsy hemostasis, anxiety, and depression in patients undergoing transrectal ultrasound-guided prostate biopsy.This was a prospective-retrospective study of 300 patients who underwent systematic 12-core prostate biopsy from August 2016 through March 2018. The ORCP was inserted into the rectum immediately after prostate biopsy in the prospective group (n = 150), while the retrospective group (n = 150) underwent prostate biopsy alone. The frequency rate and duration of hematuria, rectal bleeding, and hematospermia were compared between the 2 groups. Anxiety and depression were assessed with the hospital anxiety and depression scale before and after prostate biopsy in the prospective group.The frequency rates of hematuria and hematospermia showed no significant differences between the prospective versus retrospective groups (64.7% vs 66.7%, P = .881; 18 vs 20%, P = .718; respectively). Frequency of rectal bleeding was significantly lower in the prospective group than in the retrospective group (26.7% vs 42.7%, P = .018). However, there were no significant differences in median duration of rectal bleeding, hematuria, or hematospermia between the 2 groups (2, 5, and 2 days vs 2, 7, and 1 day, P > .05, respectively, for the prospective vs retrospective group). Multivariate analysis found that ORCP insertion was a significant protective factor against postbiopsy rectal bleeding (P = .038, odds ratio 0.52). Only anxiety level in the prospective group before versus after prostate biopsy was significantly reduced (5 vs 4, P = .011).ORCP insertion after prostate biopsy is an effective and simple method for decreasing rectal bleeding. ORCP insertion may also alleviate anxiety in patients undergoing prostate biopsy.
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Affiliation(s)
- Ji Woon Park
- Department of Urology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea
| | - Jung Im Kim
- Department of Radiology, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Republic of Korea
| | - Sang Rak Bae
- Department of Urology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea
| | - Yong Seok Lee
- Department of Urology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea
| | - Chang Hee Han
- Department of Urology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea
| | - Sung Hak Kang
- Department of Urology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea
| | - Bong Hee Park
- Department of Urology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea
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Bon I, Bartolí R, Lorenzo-Zúñiga V. Endoscopic shielding technique, a new method in therapeutic endoscopy. World J Gastroenterol 2017; 23:3761-3764. [PMID: 28638215 PMCID: PMC5467061 DOI: 10.3748/wjg.v23.i21.3761] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2017] [Revised: 03/21/2017] [Accepted: 05/04/2017] [Indexed: 02/06/2023] Open
Abstract
Prevention of late complications after large endoscopic resection is inefficient with current methods. Endoscopic shielding, as a simple and safe technique, has been proposed to improve the incidence of these events. Different methods, sheets or hydrogels, have showed proven efficacy in the prevention of late bleeding and perforation, as well as the improvement of tissue repair, in experimental models and in clinical practice.
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