NCT04894838Recruiting
DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 13 Apr 2021
- Start date
- 1 May 2021
- Primary completion date
- Sept 2029
- Lead sponsor
- St. Antonius Hospital
- Diseases
- Obesity
- NCT number
- NCT04894838
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 May 2021 to the primary completion date, Sept 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant disease (such as carcinomas and neurodegenerative disorders);
- Noncompliance in follow-up or unwilling to undergo surgery;
Other illness
- Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation \>50 mL, gastro-gastric fistula, gastro-jejunostomy);
- Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea;
Other
- Distalisation of RYGB is technical infeasible (judgment by surgeon);
- Pregnant women;
- Inability of reading/understanding and filling out questionnaires.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Rijnstate Hospital Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Not yet recruiting |
| Groene Hart Hospital Coordinator of this site? Confirm its status | Gouda | Netherlands | Not yet recruiting |
| Medisch Centrum Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Bravis Hospital Coordinator of this site? Confirm its status | Roosendaal | Netherlands | Recruiting |
| Elisabeth-TweeSteden Hospital Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.