A clinical trial to study the effects in Sleeve Gastrectomy Patients in Morbid Obesity and related Diseases.

Phase 4

Recruiting

Conditions: Morbid obesity and related diseases.

Registration Number: CTRI/2011/05/001717

Lead Sponsor: Synovis Surgical Innovations

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Adult males or females with a age between 18-75 yrs.
2.subject /LAR must be able to give written informed consent form.
3 Must have a BMI 32.5kg/m2 with one or more co morbidities or BMI 37.5kg/m2.
Must be willing and able to return for follow up visits.
5 Subject should be a good candidate for sleeve Gastrectomy.

Exclusion Criteria

1.Subject must not have previous or known allergy or sensitivity to bovine products.
No previous abdominal history that could affect the outcome of the trial.
Uncontrolled Hypertension.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the staple line bleeds and staple line leaks associated with the use of PSDV as staple line reinforcement during LSG surgery versus a control group.	18 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the Operating room time and the number of clips and or sutures used to control bleeding in the PSDV group versus the control group.	18 months.

Trial Locations

Locations (2): Poona Hospital and Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Ruby Hall Clinic
🇮🇳
Pune, MAHARASHTRA, India
Poona Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dr Jayshree Todkar
Principal investigator
09823090505
jayatodkar@hotmail.com