Laparoscopic Ileal Interposition and Weight Regain
Brazil30 participantsStarted 2023-12-01
Plain-language summary
The investigators will study the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones
Who can participate
Age range
21 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
Timeframe: Change from baseline and after 6 months post-surgery
2
Changes of Health-related quality of life of participants after Ileal interposition surgery as reported by 36-Item Short-Form Health Survey questionnaire
Timeframe: Change from Baseline and after 6 months post-surgery