Laparoscopic Ileal Interposition and Weight Regain
- Conditions
- Obesity
- Interventions
- Procedure: Ileal InterpositionProcedure: Traditional surgical technique
- Registration Number
- NCT05931939
- Lead Sponsor
- Rio de Janeiro State University
- Brief 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
- Detailed Description
This prospective, controlled, randomized intervention study will investigate the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, health-related quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones. The participants will also be assessed for alcohol abuse, depressive symptoms, level of physical activity, eating disorder symptoms, and dumping syndrome.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ileal Interposition Ileal Interposition Interposition ileal surgery group Procedure/Surgery: Bariatric surgery Traditional surgical technique Traditional surgical technique Conventional revisional surgery group Procedure/Surgery: Bariatric surgery
- Primary Outcome Measures
Name Time Method Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms Change from baseline and after 6 months post-surgery Weight loss will be obtained as the difference between preoperative weight and minimum postoperative weight in kilograms
Changes of Health-related quality of life of participants after Ileal interposition surgery as reported by 36-Item Short-Form Health Survey questionnaire Change from Baseline and after 6 months post-surgery Health-related quality of life will be assessed using the 36-Item Short-Form Health Survey questionnaire
- Secondary Outcome Measures
Name Time Method Changes in alcohol abuse of participants after Ileal interposition surgery as reported by Alcohol Use Disorders Identification Test Change from baseline and after 6 and 12 months post-surgery Alcohol abuse will be assessed using the Alcohol Use Disorders Identification Test
Change of body composition of participants after Ileal interposition surgery as measured by lean and fat mass in kilograms Change from baseline and after 6 and 12 months post-surgery Body composition will be assessed through dual X-ray absorptiometry (DXA)
Change of inflammatory biomarkers and incretin hormones of participants after Ileal interposition surgery as assessed by serum levels of tumor necrosis factor-alpha, interleukin-6, ghrelin, and glucagon-like peptide-1. Change from baseline and after 6 months post-surgery Blood sample collection will include serum levels of tumor necrosis factor-alpha, interleukin-6, ghrelin, and glucagon-like peptide-1.
Changes in the eating disorder symptoms of participants after Ileal interposition surgery as reported by the Eating Disorder Examination Questionnaire Change from baseline and after 6 and 12 months post-surgery Eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire
Changes in depressive symptoms of participants after Ileal interposition surgery as reported by Beck Depression Inventory Change from baseline and after 6 and 12 months post-surgery Depressive symptoms will be assessed using the Beck Depression Inventory questionnaire
Changes in the level of physical activity of participants after Ileal interposition surgery as reported by the International Physical Activity Questionnaire Change from baseline and after 6 and 12 months post-surgery Levels of physical activity will be assessed using the International Physical Activity Questionnaire
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms Change from baseline and after 3, 6, and 12 months post-surgery Weight loss will be obtained as the difference between preoperative weight and minimum
Change of metabolic profile of participants after Ileal interposition surgery as assessed by serum levels of glucose and insulin Change from baseline and after 6 and 12 months post-surgery Blood sample collection will include serum levels of glucose and insulin
Trial Locations
- Locations (1)
State University of Rio de Janeiro
🇧🇷Rio de Janeiro, Brazil