DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Recruiting · NCT04894838 · Interventional (participants receive a specific treatment) · Lead sponsor: St. Antonius Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
8 locations listed.
- Rijnstate Hospital - Arnhem, Gelderland, Netherlands
- Catharina Ziekenhuis - Eindhoven, North Brabant, Netherlands
- Bravis Hospital - Roosendaal, North Brabant, Netherlands
- Elisabeth-Tweesteden Hospital - Tilburg, North Brabant, Netherlands
- OLVG - Amsterdam, North Holland, Netherlands
- Medisch Centrum Leeuwarden - Leeuwarden, Provincie Friesland, Netherlands
- Groene Hart Hospital - Gouda, South Holland, Netherlands
- St. Antonius hospital - Nieuwegein, Utrecht, Netherlands