N-Butyl-2-Cyanoacrylate Adhesive Versus Absorbable Tacks in Laparoscopic Groin Hernia Repair: A Multicenter Randomized Clinical Trial.

Autor:	Petro CC; From the Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH., Poulose BK; Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH., Rosen MJ; From the Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH., Carbonell AM 2nd; Department of Surgery, Prisma Health Upstate, University of South Carolina School of Medicine, Greenville, SC., El-Ghazzawy AG; Overlake Medical Center, Department of Surgery, Bellevue, WA., Warren JA; Department of Surgery, Prisma Health Upstate, University of South Carolina School of Medicine, Greenville, SC., Lo Menzo E; Overlake Medical Center, Department of Surgery, Bellevue, WA., Prabhu AS; From the Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH., Krpata DM; From the Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH., Szomstein S; Overlake Medical Center, Department of Surgery, Bellevue, WA., Narula V; Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH., Totten CF; Department of Surgery, University of Kentucky College of Medicine, Lexington, KY., Haisley KR; Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH., Bernard AC; Department of Surgery, University of Kentucky College of Medicine, Lexington, KY., Berdel HO; Department of Surgery, University of Kentucky College of Medicine, Lexington, KY., Reynolds JK; Department of Surgery, University of Kentucky College of Medicine, Lexington, KY., Warriner ZD; Department of Surgery, University of Kentucky College of Medicine, Lexington, KY., Roth JS; Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.
Jazyk:	angličtina
Zdroj:	Annals of surgery open : perspectives of surgical history, education, and clinical approaches [Ann Surg Open] 2024 Jul 15; Vol. 5 (3), pp. e462. Date of Electronic Publication: 2024 Jul 15 (Print Publication: 2024).
DOI:	10.1097/AS9.0000000000000462
Abstrakt:	Objective: We aimed to determine whether n-butyl-2-cyanoacrylate (NB2C) adhesive is a safe and effective mechanism for nonpenetrating mesh and peritoneal fixation during laparoscopic groin hernia repair. Background: Chronic pain after laparoscopic groin hernia repair has been associated with penetrating fixation, but there had been no US Food and Drug Administration-approved devices for nonpenetrating fixation in this context. Methods: Patients undergoing laparoscopic transabdominal preperitoneal (TAP) or totally extraperitoneal (TEP) groin hernia repair with mesh at 1 of 5 academic medical centers were randomized to mesh (TAP/TEP) and peritoneal (TAP) fixation with NB2C adhesive or absorbable tacks. The primary outcome was improvement in pain (visual analog scale [VAS]) at 6 months. The noninferiority margin was 0.9 (α = 0.025; β = 80%). Recurrence, successful use of the device, quality of life, and rates of adverse events (AEs) were secondary outcomes. Results: From 2019 to 2021, 284 patients were randomized to either NB2C adhesive or absorbable tacks (n = 142/142). Patient and hernia characteristics were comparable, and 65% were repaired using a TAP approach. The difference in VAS improvement at 6 months with NB2C adhesive was not inferior to absorbable tacks in intention-to-treat and per-protocol analyses, respectively (0.25 [95% CI, -0.33 to 0.82]; P = 0.013; 0.22 [95% CI, -0.36 to 0.80], noninferiority P = 0.011). There were no differences in secondary outcomes including recurrence, successful use of each device to fixate the mesh and peritoneum, quality of life, and additional VAS pain scores. Rates of adverse and serious AEs were also comparable. Conclusions: NB2C adhesive is safe and effective for mesh fixation and peritoneal closure during laparoscopic groin hernia repair. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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