title: Buttressing the staple line: a randomized comparison between staple-line reinforcement versus no reinforcement during sleeve gastrectomy.
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.
authors.affiliation: Department of Laparoscopic and Bariatric Surgery, Dr. L. H. Hiranandani Hospital, Mumbai, India, drshashankshah@rediffmail.com.
authors.forename: Shashank S
authors.initials: SS
authors.lastname: Shah
authors.forename: Jayashree S
authors.initials: JS
authors.lastname: Todkar
authors.forename: Poonam S
authors.initials: PS
authors.lastname: Shah
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D015994:Incidence; D007194:India; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control; D011184:Postoperative Period; D017792:Surgical Stapling / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome