Study To Compare Effect of Extent Of Resection of Stomach During Laproscopic Sleeve Gastrectomy For Morbidly Obese

Phase 4

Completed

Conditions: MORBID OBEISITY

Registration Number: CTRI/2018/08/015191

Lead Sponsor: AIIMS

Brief Summary: Bariatric or Metabolic surgery has emerged as an effective and durable treatment for morbidly obese as it induces good weight loss,decreased comorbidities like Diabetes and hypertension and gives a better quality of life.

Laproscopic Sleeve gastrectomy is one of the type of various surgeries done for morbidly obese patients but there are various controversies regarding the operating technique such as the size of the bougie used, distance of pylorus from the staple line,reinforcement of staple line and use of intraoperative seal test.

Our study will deal with one of the debatable issue that is the distance of pylorus from staple line. Patient will be randomised in two groups i.e Antral preservation (5 cm from pylorus) and Antral resection (2cm from the pylorus) and the outcomes will be measured at 0, 3,6 and 12 months in terms of weight loss as primary outcome and comorbidity resolution , complication and gastric emptying time as secondary outcome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70

Inclusion Criteria

Includes accepted indications for bariatric surgery like 1.Body mass index (BMI) â‰¥ 40 kg/m2 or BMI â‰¥ 35 kg/m2 with atleast one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea) 2.Age between 20 and 60years 3.Failure of conservative treatment over2 years.

Exclusion Criteria

1.Significant GERD symptoms 2.Erosive esophagitis on UGIE 3.Poorly controlled significant medical or psychiatric disorders 4.Active alcohol or substance abuse 5.Active duodenal/gastric ulcer disease 6.Previous major gastrointestinal surgery 7.End-stage organ disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent excess weight loss	3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
1.Gastric emptying time	2.GERD symptoms

Trial Locations

Locations (1): AIIMS, NEW DELHI
🇮🇳
North, DELHI, India
AIIMS, NEW DELHI
🇮🇳North, DELHI, India
Dr Devender Singh
Principal investigator
9813643337
devinderkuntal@gmail.com