Comparing the outcomes of Laparoscopic Roux-en-Y gastric bypass versus Laparoscopic sleeve gastrectomy with duodenojejunal bypass in super morbidly obese patients: A prospective single-center non-inferiority randomized clinical trial (CU BYPASS-DJB trial)

Phase 2

Recruiting

• Conditions: Super morbid obesity; Bariatric surgery; Sleeve gastrectomy; Duodenojejunal bypass; Roux-en-Y gastric bypass; Thai

• Registration Number: TCTR20221226001
• Lead Sponsor: Research Affairs, Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-26
• Last Update Posted: 19 August 2024
• Study Completion: 2027-09-09

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. meet the criteria for bariatric surgery and have been diagnosed with super morbid obesity, with a BMI greater than 50 kilograms per square meter but less than 60 kilograms per square meter.
2. Age 18 to 60 years old
3. Attempted to lose weight but was unsuccessful with other methods such as taking medication and exercising as recommended by a doctor.

Exclusion Criteria

1. Patient unable to undergo surgery due to a severe underlying disease, such as severe heart disease or chronic kidney disease.
2. Patients with bariatric surgery histories.
3. Patients with GERD who do not react to medicine, have severe symptoms, or have a hiatal hernia
4. Patients diagnosed psychiatry disease effect the eating habits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
%Excess weight loss (%EWL) 1 month, 3 month, 6 month, 1 year, 1 year 6 month, 2 year, 3 year, 4 year, 5 year Initial Weight, Postop Weight, Ideal Weight,%Excess BMI loss (%EBMIL) 1 month, 3 month, 6 month, 1 year, 1 year 6 month, 2 year, 3 year, 4 year, 5 years change in BMI, Initial BMI

Secondary Outcome Measures

Name	Time	Method
Hypertension 6 month, 1 year Blood pressure change,Type 2 diabetes 6 month, 1 year HbA1C change,Dyslipidemia 6 month, 1 year Laboratory value change,OSA 6 month, 1 year CPAP use,Operative time within operation minutes,Operative blood loss within operation ml