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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)

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)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221226001
Enrollment
50
Registered
2022-12-26
Start date
2022-09-09
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Super morbid obesity Bariatric surgery Sleeve gastrectomy Duodenojejunal bypass Roux-en-Y gastric bypass Super morbid obesity Thai

Interventions

The procedure include standard sleeve gastrectomy with additional roux-en-y duodeno-jejunal bypass (bilio-pancreatic limb 100-cm in length and alimentary limb 100-cm in length),The procedure include s
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Laparoscopic sleeve gastrectomy with duodeno-jejunal bypass,Laparoscopic Roux-en-Y gastric bypass

Sponsors

Research Affairs, Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
%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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPattharasai Kachornvitaya

Faculty of Medicine, Chulalongkorn University

pk_first17@hotmail.com66890354746

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026