Surgery to address weight regain after gastric bypass
Ileal Interposition to the Treatment of Weight Regain After Roux-en-Y Gastric Bypass: a Randomized Controlled Trial
This study tests if a new surgery can help people who have gained weight back after gastric bypass surgery to lose weight and improve their overall health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Rio de Janeiro State University Academic / other |
| Locations | 1 site (Rio de Janeiro) |
| Trial ID | NCT05931939 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on using ileal interposition to treat patients who have regained weight after undergoing Roux-en-Y gastric bypass surgery. The study will assess various outcomes including weight loss, body composition, quality of life, and metabolic and inflammatory biomarkers. Participants will also be evaluated for psychological factors such as alcohol abuse, depressive symptoms, and eating disorders. The study employs a controlled, randomized design to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are individuals who have undergone Roux-en-Y gastric bypass at least three years prior, have lost 60-80% of their excess weight, and are experiencing significant weight regain.
Not a fit: Patients with active substance dependencies, severe psychiatric disorders, or other significant health issues may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could help patients achieve sustainable weight loss and improve their overall health after previous weight regain.
How similar studies have performed: While similar surgical interventions have been explored, this specific approach of ileal interposition for weight regain after gastric bypass is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients submitted to initial laparoscopic after initial Roux-en-Y gastric bypass for at least 3 years * Loss of excess weight between 60 to 80% * Rate of weight regain ≥60% * Body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2, with at least 2 comorbidities associated with obesity * Present a previous evaluation by the multidisciplinary team with a favorable opinion of the revision surgery. Exclusion Criteria: * Active chemical dependency on alcohol and/or illicit drugs * Severe psychotic or depressive disorder or history of suicide attempts in the last 12 months * Eating behavior disorder (uncontrolled) * Secondary causes of obesity * Pregnancy * Severe organ failure * Active neoplastic * Infectious or inflammatory disease * Severe coagulopathy * High anesthetic-surgical risk * Intellectual inability * Lack of preoperative follow-up
Where this trial is running
Rio de Janeiro
- State University of Rio de Janeiro — Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Principal investigator: Luiz Guilherme Kraemer-Aguiar, PhD — State University of Rio de Janeiro
- Study coordinator: Luiz Guilherme G Kraemer-Aguiar, PhD
- Email: lgkraemeraguiar@gmail.com
- Phone: +55 21 23340703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.