Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: ANTRAL RESECTION: Patients in this group will have gastric resection starting at 2 cm or less from the pylorus.
Control Intervention1: ANTRAL PRESERVATION: Patients in this group will h
Sponsors
AIIMS
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. GerdQ score before and at 12 months (FOR PROSPECTIVE ARM) or 24 months(for retrospective arm) after sleeve gastrectomy 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 Timepoint: 1. GerdQ score before and at 12 months (FOR PROSPECTIVE ARM) or 24 months(for retrospective arm) after sleeve gastrectomy 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact on upper gastrointestinal endoscopic findings 2. Gastric emptying time evaluated by Radionuclide scintigraphy 3. % excess weight loss 4. Weight regain 5. 30-day mortality and morbidity (complication/ readmission/reintervention) rate 6. Perioperative/ post-operative staple line leak/bleed 7. Impact on comorbidities including Type 2 Diabetes Mellitus, Hypertension, Obstructive sleep apnea and Non -Alcoholic fatty liver disease/Non-alcoholic steatohepatitis (NAFLD/NASH) Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactPROF SANDEEP AGGARWAL
AIIMS DELHI
Outcome results
None listed