Actively Recruiting
DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Led by St. Antonius Hospital · Updated on 2026-04-27
150
Participants Needed
8
Research Sites
13 weeks
Total Duration
On this page
Sponsors
S
St. Antonius Hospital
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical methods of distal gastric bypass (DGB) as revisional surgery for patients who have had insufficient weight loss or weight regain after Roux-en-Y gastric bypass (RYGB). This multicenter randomized controlled trial aims to determine which DGB technique is better for total weight loss and managing protein calorie malnutrition. The study involves morbidly obese patients eligible for distalisation surgery, addressing a gap in consensus for optimal surgical approaches after failed RYGB. Participants will be randomly assigned to one of two groups: DGB type I, which involves lengthening the biliopancreatic limb by modifying the Roux limb and reattaching it further along the intestine, or DGB type II, which lengthens the alimentary limb by dividing and reattaching the biliopancreatic limb. Both procedures are performed laparoscopically. The trial includes follow-up visits at 1.5, 3, 6, 12, 18, 24, and 36 months after surgery to monitor outcomes. During the study, participants will undergo regular clinical and outpatient assessments including weight measurements, evaluation of protein calorie malnutrition, defecation patterns, nutritional deficiencies, and quality of life questionnaires. Researchers will track weight loss and malnutrition treatment needs primarily at one year post-surgery, with additional secondary outcomes assessed up to three years. Patient satisfaction and eating behavior will also be evaluated throughout the follow-up period. The total participation spans up to three years to thoroughly assess long-term effects and safety.
CONDITIONS
Brief Title
DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Body mass index (BMI) of 40 kg/m2 or higher, or BMI of 35 kg/m2 or higher with obesity-related health problems
- Weight regain or insufficient weight loss after Roux-en-Y gastric bypass surgery
- Multidisciplinary team screening at one of the bariatric centers
- Provided informed consent and willing to participate in follow-up program
You will not qualify if you...
- Failed Roux-en-Y gastric bypass due to anatomical or surgical reasons such as gastric pouch dilatation over 50 mL, gastro-gastric fistula, or gastro-jejunostomy
- Distalisation of RYGB not technically feasible as judged by surgeon
- Inflammatory bowel disease, celiac disease, irritable bowel syndrome, or other causes of chronic diarrhea
- Severe other diseases like cancers or neurodegenerative disorders
- Pregnant women
- Unwillingness or noncompliance with follow-up or surgery
- Inability to read, understand, or complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo laparoscopic distalisation of their Roux-en-Y gastric bypass using one of two surgical techniques as revisional surgery.
1 surgery visit
Duration - Up to 3 years
Participants are monitored for weight loss, nutritional status, complications, and quality of life after surgery.
Visits at 3, 6, 12, 18, 24, and 36 months post surgery
Trial Site Locations
Total: 8 locations
1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
Actively Recruiting
2
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
Not Yet Recruiting
3
Bravis Hospital
Roosendaal, North Brabant, Netherlands, 4708 AE
Actively Recruiting
4
Elisabeth-Tweesteden Hospital
Tilburg, North Brabant, Netherlands, 5022 GC
Actively Recruiting
5
OLVG
Amsterdam, North Holland, Netherlands, 1061 AE
Actively Recruiting
6
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
Actively Recruiting
7
Groene Hart Hospital
Gouda, South Holland, Netherlands, 2803 HH
Not Yet Recruiting
8
St. Antonius hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Actively Recruiting
Research Team
L
Luna Tolenaars, MD
M
M.J. Wiezer, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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