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
448 weeks
Total Duration
On this page
Sponsors
S
St. Antonius Hospital
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- BMI 60 kg/m2 or BMI 5 kg/m2 with obesity-related comorbidity
- Weight regain or insufficient weight loss (EWL <50% or TWL <20%) following Roux-en-Y gastric bypass
- Multidisciplinary team screening at one of the bariatric centers
- Informed consent and willingness to enter the follow-up program
You will not qualify if you...
- Failed Roux-en-Y gastric bypass due to anatomical or surgical reasons (gastric pouch dilation >50 mL, gastro-gastric fistula, gastro-jejunostomy)
- Distalisation of Roux-en-Y gastric bypass technically infeasible (surgeon's judgment)
- Inflammatory bowel disease, celiac disease, irritable bowel syndrome, or other causes of chronic diarrhea
- Severe concomitant diseases such as carcinomas or neurodegenerative disorders
- Pregnant women
- Noncompliance with follow-up or unwillingness to undergo surgery
- Inability to read, understand, or complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
M.J. Wiezer, PhD, MD
CONTACT
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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