Comparing two types of distal gastric bypass for patients with weight regain after gastric bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective multicenter randomized controlled trial that aims to compare two surgical techniques of distal gastric bypass (DGB) in patients who have experienced insufficient weight loss or weight regain after Roux-en-Y gastric bypass (RYGB). Participants will be randomly assigned to either DGB with lengthening of the biliopancreatic limb (BPL) or DGB with extended alimentary limb (AL). The study will involve regular follow-up visits at specified intervals over three years to assess total weight loss and the need for treatment of protein calorie malnutrition. The trial will be conducted across multiple bariatric centers to gather a diverse patient population.

Why it matters

Who can join: the full rules

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's running

• Rijnstate Hospital
  Arnhem, Gelderland, Netherlands Recruiting
• Bravis Hospital
  Roosendaal, North Brabant, Netherlands Recruiting
• Elisabeth-Tweesteden Hospital
  Tilburg, North Brabant, Netherlands Recruiting
• Olvg
  Amsterdam, North Holland, Netherlands Recruiting
• Medisch Centrum Leeuwarden
  Leeuwarden, Provincie Friesland, Netherlands Recruiting
• St. Antonius hospital
  Nieuwegein, Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: M.J. Wiezer, PhD, MD — St. Antonius Hospital
• Study coordinator: Luna Tolenaars, MD
• Email: l.tolenaars@antoniusziekenhuis.nl
• Phone: 0031636434456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.