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.
Highlights
The World Health Organization reports that >1.4 billion adults are overweight and that nearly 500 million are obese,[1] contributing to a global increase in obesity-related comorbidities, including hypertension, type 2 diabetes mellitus, and cardiovascular disease [2].Obesity often occurs in developing countries in tandem with under-nutrition, affecting most ages and socioeconomic groups [1]
These results are consistent with reports of a reduced rate of staple-line failures with the use of bovine pericardium as buttress material in sleeve gastrectomy [13, 19]
Subgroup analyses according to body mass index (BMI) demonstrated fewer staple-line bleeds in patients with a BMI ≤43 and in patients who received Peri-Strips Dry® with Veritas® (PSD-V) compared with the control group, but no difference was observed between treatment groups in patients with a BMI >43
Summary
The World Health Organization reports that >1.4 billion adults are overweight and that nearly 500 million are obese,[1] contributing to a global increase in obesity-related comorbidities, including hypertension, type 2 diabetes mellitus, and cardiovascular disease [2].Obesity often occurs in developing countries in tandem with under-nutrition, affecting most ages and socioeconomic groups [1]. In 2005–2006, 12.6 % of women and 9.7 % of men were considered overweight or obese in India, based on a body mass index (BMI) ≥25.0 [3]. It is recognized that Asian Indians are at greater risk of obesityrelated comorbidities at lower levels of BMI and waist circumference/waist-to-hip ratio; alternative cutoff points for definitions of “overweight” and “obese” may be more appropriate [4, 5]. It is recommended that an Indian is considered overweight with a BMI of 23.0–24.9 kg/m2 and obese with a BMI >25 kg/m2 [6]. The Consensus Statement for Asian Indians recommends bariatric surgery for patients with a BMI >32.5 kg/m2 and a comorbidity and for patients who have a BMI >37.5 kg/m2 without a comorbidity [6]. Sleeve gastrectomy evolved from a larger gastric component of the duodenal switch with
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