DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Antonius Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Distal gastric bypass
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
St. Antonius Hospital
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov