A Randomised study of LinEar Staple Line Reinforcement in Sleeve Gastrectomy Patients using Peristrips Dry with Veritas Collagen Matrix .

Obesity is an epidemic that is becoming recognized as a major public health risk throughout the world.  The World Health Organization reports that 1.6 billion adults are overweight worldwide and at least 400 million are clinically obese.1 Obesity often occurs in developing countries in tandem with under-nutrition and affects nearly all ages and socioeconomic groups.2 In India, approximately 30-65% of  the population is considered overweight, obese or have abdominal obesity. The rising percentage of obese people in India is contributing to the global increase in obesity-related comorbidities such as hypertension, type 2 diabetes mellitus and cardiovascular disease.3

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According to the Consensus Statement for Diagnosis of Obesity, Abdominal Obesity and the Metabolic Syndrome for Asian Indians and Recommendations for Physical Activity, Medical and Surgical Management, an Indian is considered overweight with a Body Mass Index (BMI) of 23.0 – 24.9 kg/m2 and obese with a BMI of greater than 25 kg/m2.3

 There are a number of medical, dietary, and surgical options for the treatment of obesity.  Medical and dietary options are typically attempted prior to performing gastric surgery.  The Consensus Statement for Asian Indians recommends pharmacotherapy for people with a BMI greater than 25 kg/m2 with an associated comorbidity or greater than 27 kg/m2 without a comorbidity. Gastric surgery is recommended for a BMI above 32.5 kg/m2 with a comorbidity or 37.5 kg/m2 without a comorbidity.3

 In sleeve gastrectomy surgery, staple line leaks and staple line bleeding are two common reportable events.  Surgeons throughout the world performing sleeve gastrectomy surgery have found the use of a buttress material to be beneficial.  Peri-Strips Dry® with Veritas® (PSDV) manufactured by Synovis Surgical Innovations has been used to reinforce staple lines thus preventing serious adverse events.  This product has been cleared for use in the US and India and has received CE Mark in Europe. This clinical trial is being conducted to evaluate the complication rates of PSDV as staple line reinforcement during sleeve gastrectomy surgery.