Laparoscopic Ileal Interposition and Weight Regain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ileal Interposition to the Treatment of Weight Regain After Roux-en-Y Gastric Bypass: a Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Ileal Interposition
* Procedure: Traditional surgical technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ileal Interposition<br>Interposition ileal surgery group Procedure/Surgery: Bariatric surgery | Procedure: Ileal Interposition<br>* Bariatric surgery by laparoscopic Ileal Interposition<br>|
| Active Comparator: Traditional surgical technique<br>Conventional revisional surgery group Procedure/Surgery: Bariatric surgery | Procedure: Traditional surgical technique<br>* Bariatric surgery by laparoscopic traditional technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms | Weight loss will be obtained as the difference between preoperative weight and minimum postoperative weight in kilograms | Change from baseline and after 6 months post-surgery | 
| Changes of Health-related quality of life of participants after Ileal interposition surgery as reported by 36-Item Short-Form Health Survey questionnaire | Health-related quality of life will be assessed using the 36-Item Short-Form Health Survey questionnaire | Change from Baseline and after 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms | Weight loss will be obtained as the difference between preoperative weight and minimum | Change from baseline and after 3, 6, and 12 months post-surgery | 
| Change of body composition of participants after Ileal interposition surgery as measured by lean and fat mass in kilograms | Body composition will be assessed through dual X-ray absorptiometry (DXA) | Change from baseline and after 6 and 12 months post-surgery | 
| Change of metabolic profile of participants after Ileal interposition surgery as assessed by serum levels of glucose and insulin | Blood sample collection will include serum levels of glucose and insulin | Change from baseline and after 6 and 12 months post-surgery | 
| 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. | Blood sample collection will include serum levels of tumor necrosis factor-alpha, interleukin-6, ghrelin, and glucagon-like peptide-1. | Change from baseline and after 6 months post-surgery | 
| Changes in alcohol abuse of participants after Ileal interposition surgery as reported by Alcohol Use Disorders Identification Test | Alcohol abuse will be assessed using the Alcohol Use Disorders Identification Test | Change from baseline and after 6 and 12 months post-surgery | 
| Changes in depressive symptoms of participants after Ileal interposition surgery as reported by Beck Depression Inventory | Depressive symptoms will be assessed using the Beck Depression Inventory questionnaire | Change from baseline and after 6 and 12 months post-surgery | 
| Changes in the level of physical activity of participants after Ileal interposition surgery as reported by the International Physical Activity Questionnaire | Levels of physical activity will be assessed using the International Physical Activity Questionnaire | Change from baseline and after 6 and 12 months post-surgery | 
| Changes in the eating disorder symptoms of participants after Ileal interposition surgery as reported by the Eating Disorder Examination Questionnaire | Eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire | Change from baseline and after 6 and 12 months post-surgery |