DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Recruiting now · Not applicable
Conditions studied: Obesity, Morbid, Weight Gain
In brief
This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.
Key facts
- Study ID
- NCT04894838
- Run by
- St. Antonius Hospital
- People needed
- 150
- Starts
- 2021-05-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-65 years;
- BMI ≥40 kg/m2 or BMI ≥35 kg/m2 with obesity related comorbidity;
- Weight regain or insufficient weight loss (EWL<50% or TWL<20%)15,16 following RYGB;
- Multidisciplinary team screening at one of the bariatric centres;
- Informed consent and willing to enter the follow-up program.
You may not qualify if…
- Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation >50 mL, gastro-gastric fistula, gastro-jejunostomy);
- Distalisation of RYGB is technical infeasible (judgment by surgeon);
- Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea;
- Severe concomitant disease (such as carcinomas and neurodegenerative disorders);
- Pregnant women;
- Noncompliance in follow-up or unwilling to undergo surgery;
- Inability of reading/understanding and filling out questionnaires.
Where it is running
- St. Antonius hospital — Nieuwegein, Utrecht, Netherlands (enrolling)
- Medisch Centrum Leeuwarden — Leeuwarden, Provincie Friesland, Netherlands (enrolling)
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (enrolling)
- Bravis Hospital — Roosendaal, North Brabant, Netherlands (enrolling)
- Elisabeth-Tweesteden Hospital — Tilburg, North Brabant, Netherlands (enrolling)
- OLVG — Amsterdam, North Holland, Netherlands (enrolling)
- Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands
- Groene Hart Hospital — Gouda, South Holland, Netherlands
Full record on ClinicalTrials.gov
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