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

Launched by ST. ANTONIUS HOSPITAL · May 16, 2021

Keywords

ClinConnect Summary

This clinical trial, called DIStal gastriC Bypass OUtcome in Revision SurgEry, is looking at two different methods of surgery to help people who have gained weight after a previous weight-loss surgery called Roux-en-Y gastric bypass. The goal is to see which of the two surgical techniques works better for patients who haven’t achieved their weight loss goals or have regained weight. Participants will be randomly assigned to one of the two techniques and will be closely monitored over three years, with regular check-ins at 1.5, 3, 6, 12, 18, 24, and 36 months.

To be eligible for this study, participants need to be between 18 and 65 years old, with a body mass index (BMI) of 40 or higher, or a BMI of 35 or higher if they have health issues related to obesity. They should have experienced weight regain or not lost enough weight after their previous surgery. It’s important that participants are willing to follow up on their progress and give informed consent. However, individuals with certain medical conditions or complications from the first surgery, among other exclusions, will not be eligible. This study is being conducted at several specialized weight-loss surgery centers, ensuring comprehensive care and support for those involved.

Gender

ALL

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.