Obesity
Conditions
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.
Interventions
PROCEDUREIleal Interposition
Bariatric surgery by laparoscopic Ileal Interposition
PROCEDURETraditional surgical technique
Bariatric surgery by laparoscopic traditional technique
Sponsors
Rio de Janeiro State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 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 |
| 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) |
Countries
Brazil
Contacts
Primary ContactLuiz Guilherme G Kraemer-Aguiar, PhD
Backup ContactKarynne Grutter Lopes, PhD
Outcome results
None listed