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

Clayton C. Petro, MD; Benjamin K. Poulose, MD; Michael J. Rosen, MD; Alfredo M. Carbonell, II, DO; Adel G. El-Ghazzawy, MD; Jeremy A. Warren, MD; Emanuele Lo Menzo, MD; Ajita S. Prabhu, MD; David M. Krpata, MD; Samuel Szomstein, MD; Vimal Narula, MD; Crystal F. Totten, MD; Kelly R. Haisley, MD; Andrew C. Bernard, MD; Henrik O. Berdel, MD; Jessica K. Reynolds, MD; Zachary D. Warriner, MD; John S. Roth, MD

doi:10.1097/AS9.0000000000000462

Annals of Surgery Open (Sep 2024)

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

Clayton C. Petro, MD,
Benjamin K. Poulose, MD,
Michael J. Rosen, MD,
Alfredo M. Carbonell, II, DO,
Adel G. El-Ghazzawy, MD,
Jeremy A. Warren, MD,
Emanuele Lo Menzo, MD,
Ajita S. Prabhu, MD,
David M. Krpata, MD,
Samuel Szomstein, MD,
Vimal Narula, MD,
Crystal F. Totten, MD,
Kelly R. Haisley, MD,
Andrew C. Bernard, MD,
Henrik O. Berdel, MD,
Jessica K. Reynolds, MD,
Zachary D. Warriner, MD,
John S. Roth, MD

Affiliations

Clayton C. Petro, MD: From the * Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH
Benjamin K. Poulose, MD: † Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH
Michael J. Rosen, MD: From the * Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH
Alfredo M. Carbonell, II, DO: ‡ Department of Surgery, Prisma Health Upstate, University of South Carolina School of Medicine, Greenville, SC
Adel G. El-Ghazzawy, MD: § Overlake Medical Center, Department of Surgery, Bellevue, WA
Jeremy A. Warren, MD: ‡ Department of Surgery, Prisma Health Upstate, University of South Carolina School of Medicine, Greenville, SC
Emanuele Lo Menzo, MD: § Overlake Medical Center, Department of Surgery, Bellevue, WA
Ajita S. Prabhu, MD: From the * Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH
David M. Krpata, MD: From the * Department of Surgery, Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH
Samuel Szomstein, MD: § Overlake Medical Center, Department of Surgery, Bellevue, WA
Vimal Narula, MD: † Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH
Crystal F. Totten, MD: ∥ Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.
Kelly R. Haisley, MD: † Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH
Andrew C. Bernard, MD: ∥ Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.
Henrik O. Berdel, MD: ∥ Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.
Jessica K. Reynolds, MD: ∥ Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.
Zachary D. Warriner, MD: ∥ Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.
John S. Roth, MD: ∥ Department of Surgery, University of Kentucky College of Medicine, Lexington, KY.

DOI: https://doi.org/10.1097/AS9.0000000000000462
Journal volume & issue: Vol. 5, no. 3
p. e462

Abstract

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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.

Published in Annals of Surgery Open

ISSN: 2691-3593 (Online)
Publisher: Wolters Kluwer Health
Country of publisher: United States
LCC subjects: Medicine: Surgery
Website: https://journals.lww.com/aosopen/pages/default.aspx

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