Buttressing the Staple Line: A Randomized Comparison Between Staple-Line Reinforcement Versus No Reinforcement During Sleeve Gastrectomy

摘要

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 (R) with Veritas (R) (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-Vor 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 intraoperative 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.