Buttressing the Staple Line: A Randomized Comparison Between Staple-Line Reinforcement Versus No Reinforcement During Sleeve Gastrectomy |
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Authors: | Shashank S Shah Jayashree S Todkar Poonam S Shah |
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Institution: | 1. Department of Laparoscopic and Bariatric Surgery, Dr. L. H. Hiranandani Hospital, Mumbai, India 2. Ruby Hall Clinic, Laparo-Obeso Centre, 40, Sassoon Road, Pune, 411001, India 3. Poona Hospital, 27, Sadashiv Peth, Pune, 411001, India
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Abstract: | Bariatric surgery is recommended for Indian patients with body mass index (BMI) >32.5 kg/m2 with at least one comorbidity and >37.5 kg/m2 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. |
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