Buttressing the staple line: a randomized comparison between staple-line reinforcement versus no reinforcement during sleeve gastrectomy

Obes Surg. 2014 Dec;24(12):2014-20. doi: 10.1007/s11695-014-1374-z.

Abstract

Bariatric surgery is recommended for Indian patients with body mass index (BMI) >32.5 kg/m(2) with at least one comorbidity and >37.5 kg/m(2) without a comorbidity. In laparoscopic sleeve gastrectomy, bleeding and leakage from the staple line are common post-operative events. Peri-Strips Dry® with Veritas® (PSD-V) is used in staple-line reinforcement. This was a single-investigator, multicenter, randomized study of 100 patients undergoing standard sleeve gastrectomy with a 34 or 36 French bougie. Patients were randomized 1:1 to PSD-V or control groups; no buttress material was used in the control group. The primary objective was to assess complication rates (any staple-line bleed or leak from the intra-operative visit through day 30) associated with sleeve gastrectomy. Surgical time (from first incision to closure of last incision) and the number of clips and/or sutures used to control bleeding were also assessed. Fewer staple-line bleeds were observed in the PSD-V group than the control group (23/51 [45.1 %] vs 39/49 [79.6 %] patients; p=0.0005), and the bleeding was of a lower severity (p=0.0002). No staple-line leaks were observed. Surgical time was shorter in patients who received PSD-V (58.8 vs 72.8 min; p=0.0153), and fewer patients required hemostatic clips and/or sutures (10/51 [19.6 %] vs 33/49 [67.3 %] patients; p<0.0001). Fewer patients in the PSD-V than the control group experienced adverse events (2/51 [3.9 %] vs 5/49 [10.2 %] patients). The use of PSD-V reduced the incidence and severity of staple-line bleeding and was associated with a reduction in surgical time compared with no staple-line reinforcement.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Body Mass Index
  • Female
  • Gastrectomy / adverse effects
  • Gastrectomy / methods*
  • Humans
  • Incidence
  • India
  • Male
  • Middle Aged
  • Obesity, Morbid / surgery*
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / prevention & control
  • Postoperative Period
  • Surgical Stapling / adverse effects
  • Surgical Stapling / methods*
  • Treatment Outcome