Laparoscopic Ileal Interposition and Weight Regain

Launched by RIO DE JANEIRO STATE UNIVERSITY · Jun 26, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a surgical procedure called ileal interposition as a way to help people who have regained weight after an earlier weight-loss surgery known as Roux-en-Y gastric bypass. The study will look at how well this new procedure works in helping participants lose weight again, improve their body composition (the amount of fat versus muscle), and enhance their overall quality of life. Researchers will also measure various health markers related to metabolism and inflammation to see how this surgery impacts patients’ health.

To be eligible for the trial, participants need to have had the Roux-en-Y surgery at least three years ago and have lost between 60-80% of their excess weight, but are now experiencing significant weight regain (at least 60%). Candidates must have a body mass index (BMI) of 40 or higher, or 35 with related health issues. Participants can expect a thorough evaluation by a team of medical professionals to ensure that the surgery is suitable for them. It's important to note that certain medical conditions or personal circumstances, like severe mental health issues or substance dependency, may prevent someone from joining the study.

Gender

ALL

Eligibility 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