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

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

This study is testing two different types of gastric bypass surgery to see which one helps people who have regained weight after their first surgery lose weight more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: St. Antonius Hospital (Academic / other)
• Locations: 8 sites (Arnhem, Gelderland and 7 other locations)
• Trial ID: NCT04894838 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are morbidly obese individuals aged 18-65 who have not achieved sufficient weight loss or have regained weight after undergoing Roux-en-Y gastric bypass.

Not a fit: Patients who have anatomical complications from previous surgeries or other severe health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective surgical option for patients struggling with weight regain after gastric bypass surgery.

How similar studies have performed: While there is limited consensus on the optimal surgical technique for revisional surgery after RYGB, similar approaches have shown promise in addressing weight regain, making this study a valuable exploration in the field.

Eligibility criteria

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 this trial is running

Arnhem, Gelderland and 7 other locations

• Rijnstate Hospital — Arnhem, Gelderland, Netherlands (Recruiting)
• Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands (Not_yet_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)
• Groene Hart Hospital — Gouda, South Holland, Netherlands (Not_yet_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

Conditions Obesity, Morbid; Weight Gain; Obesity; Weight regain; Failed RYGB; Distal gastric bypass