Evaluation of a Powered Stapler System with Gripping Surface Technology on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy

Elliott Fegelman, Susan Knippenberg, Michael Schwiers, Dimitrios Stefanidis, Keith S Gersin, John D Scott, Adolfo Z Fernandez, Elliott Fegelman, Susan Knippenberg, Michael Schwiers, Dimitrios Stefanidis, Keith S Gersin, John D Scott, Adolfo Z Fernandez

Abstract

Background: Transection of gastric tissue during laparoscopic sleeve gastrectomy (LSG) can be challenging. Reinforcing the staple line may decrease the incidence of issues requiring intervention.

Methods: The objective of this study was to compare the number of intraoperative surgical interventions for a surgical stapler and reload system with Gripping Surface Technology (GST) to standard reloads in patients who underwent LSG. Patients who underwent elective LSG were enrolled. The study was conducted in two stages. For Stage 1, procedures were performed using a powered stapler and standard reloads. For Stage 2, a reload system with GST was used. The primary endpoint was surgical interventions for bleeding and/or staple line issues during transection of the greater curvature of the stomach. Propensity score matching was applied to create two groups similar in baseline characteristics and risk factors.

Results: A total of 111 subjects were enrolled across four centers. Propensity-matched procedures were completed with the standard (n = 38) or GST reloads (n = 38). The mean number of interventions in the standard group was 1.9 (1.29) versus 1.1 (1.45) in the GST group. Nonparametric comparisons were statistically significant, indicating a reduction in the distribution of interventions for GST subjects (P = .0036 for matched pair data). Tissue slippage during transection was low for both groups. Intraoperative leak testing was negative in all procedures, and no procedures were converted to open.

Conclusions: Use of the GST stapling system reduces the need for staple line interventions in LSG. Both stapling systems had an acceptable safety profile.

Keywords: laparoscopic sleeve gastrectomy; powered stapler; staple line interventions.

Conflict of interest statement

This clinical research was funded by Ethicon, a Johnson & Johnson company. Dr. Elliott Fegelman, Michael Schwiers, and Susan Knippenberg are employed by Ethicon, a Johnson & Johnson company. The other authors have no financial relationships to report other than clinical trial support.

Figures

FIG. 1.
FIG. 1.
Interventions for matched pairs as a percentage of subjects who had their procedures performed with ECH cartridges or GST. GST, Gripping Surface Technology.
FIG. 2.
FIG. 2.
Interventions by use of staple line reinforcement in Stage 1.
FIG. 3.
FIG. 3.
Interventions by use of staple line reinforcement in Stage 2.

References

    1. Peterli R, Steinert RE, Woelnerhanssen B, Peters T, Christoffel-Courtin C, Gass M, et al. . Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: A randomized, prospective trial. Obes Surg 2012;22:740–748
    1. Ren CJ, Patterson E, Gagner M. Early results of laparoscopic bilio-pancreatic diversion with duodenal switch: A case series of 40 consecutive patients. Obes Surg 2000;10:514–523
    1. Rosenthal RJ. International Sleeve Gastrectomy Expert Panel Consensus Statement: Best practice guidelines based on experience of 12,000 cases for the International Sleeve Gastrectomy Expert Panel. Surg Obes Relat Dis 2012;8:8–19
    1. Trastulli S, Desiderio J, Guarino S, et al. . Laparoscopic sleeve gastrectomy compared with other bariatric surgical procedures: A systematic review of randomized trials. Surg Obes Relat Dis 2013;9:816–830
    1. Sarkhosh K, Birch DW, Sharma A, Karmali S. Complications associated with laparoscopic sleeve gastrectomy for morbid obesity: A surgeon's guide. Can J Surg 2013;56:347–352
    1. Fridman A, Moon R, Cozacov Y, et al. . Procedure-related morbidity in bariatric surgery: A retrospective short- and mid-term follow-up of a single institution of the American College of Surgeons Bariatric Surgery Centers of Excellence. J Am Coll Surg 2013;217:614–620
    1. Zellmer , Mathiason MA, Kallies KJ, Kothari SN. Is laparoscopic sleeve gastrectomy a lower risk bariatric procedure compared with laparoscopic Roux-en-Y gastric bypass? A meta-analysis. Am J Surg 2014;208:903–910
    1. Clinical Issues Committee of American Society for Metabolic and Bariatric Surgery. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis 2012;8:e21–e26
    1. Choi YY, Bae J, Hur KY, Choi D, Kim YJ. Reinforcing the staple line during laparoscopic sleeve gastrectomy: Does it have advantages? A meta-analysis. Obes Surg 2012;8:1206–1213
    1. Consten EC, Gagner M, Pomp A, Inabnet WB. Decreased bleeding after laparoscopic sleeve gastrectomy with or without duodenal switch for morbid obesity using a stapled buttressed absorbable polymer membrane. Obes Surg 2004;14:1360–1366
    1. Shikora SA, Mahoney CB. Clinical benefit of gastric staple line reinforcement (SLR) in gastrointestinal surgery: A meta-analysis. Obes Surg 2015;25:1133–1141
    1. Dapri G1, Cadière GB, Himpens J. Reinforcing the staple line during laparoscopic sleeve gastrectomy: Prospective randomized clinical study comparing three different techniques. Obes Surg 2010;20:462–467
    1. Baker RS, Foote J, Kemmeter P, Brady R, Vroegop T, Serveld M. The science of stapling and leaks. Obes Surg 2004;14:1290–1298

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere