Status:
RECRUITING
DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
Medtronic
Conditions:
Obesity, Morbid
Weight Gain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
Rationale: Up to 35% of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) fail to lose sufficient weight or regain excessive weight after initial weight loss. Currently, there is no s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04894838
Start Date
May 1 2021
End Date
May 1 2027
Last Update
July 8 2024
Active Locations (8)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
2
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
3
Bravis Hospital
Roosendaal, North Brabant, Netherlands, 4708 AE
4
Elisabeth-Tweesteden Hospital
Tilburg, North Brabant, Netherlands, 5022 GC