To compare acid reflux in morbidly obese patients undergoing antral preserving type of laproscopic sleeve gastrectomy and those undergoing antral resecting type of sleeve gastrectomy
Not Applicable
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/03/031759
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Body mass index (BMI) >= 40 kg/m2 or BMI >= 35 kg/m2 with at least one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea) AND
2. Age between 18 and 65 years
Exclusion Criteria
1. Significant GERD symptoms, especially those with nocturnal and/ or extra-gastrointestinal symptoms
2. Los Angeles (LA) Grade C/D, Barrettâ??s esophagus or peptic stricture on Upper gastrointestinal (GI) endoscopy
3.Poorly controlled significant medical or psychiatric disorders (including eating disorders)
4. Active alcohol or substance abuse
5. Active duodenal/ gastric ulcer disease
6. Patients with prohibitive anesthesia risks
7. Subjects not willing for follow-up or lifestyle changes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. GerdQ score before and at 12 months (FOR PROSPECTIVE ARM) or 24 months(for retrospective arm) after sleeve gastrectomy <br/ ><br>2. Acid Exposure Time and De Meester score on 24-hr pH manometry, before and at 12 or 24 (for retrospective arm) months after sleeve gastrectomy <br/ ><br>Timepoint: 1. GerdQ score before and at 12 months (FOR PROSPECTIVE ARM) or 24 months(for retrospective arm) after sleeve gastrectomy <br/ ><br>2. Acid Exposure Time and De Meester score on 24-hr pH manometry, before and at 12 or 24 (for retrospective arm) months after sleeve gastrectomy <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Impact on upper gastrointestinal endoscopic findings <br/ ><br>2. Gastric emptying time evaluated by Radionuclide scintigraphy <br/ ><br>3. % excess weight loss <br/ ><br>4. Weight regain <br/ ><br>5. 30-day mortality and morbidity (complication/ <br/ ><br>readmission/reintervention) rate <br/ ><br>6. Perioperative/ post-operative staple line leak/bleed <br/ ><br>7. Impact on comorbidities including Type 2 Diabetes Mellitus, Hypertension, Obstructive sleep apnea and Non -Alcoholic fatty liver disease/Non-alcoholic steatohepatitis (NAFLD/NASH) <br/ ><br>Timepoint: 12 months