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DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass

RecruitingNAAges 18 Years - 65 YearsAllSt. Antonius Hospital
NCT04894838 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Distal gastric bypass
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Where

8 sites
Rijnstate Hospital
Arnhem, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Bravis Hospital
Roosendaal, Netherlands
Elisabeth-Tweesteden Hospital
Tilburg, Netherlands
OLVG
Amsterdam, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Groene Hart Hospital
Gouda, Netherlands
St. Antonius hospital
Nieuwegein, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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