Clinical trial NCT05931939: Laparoscopic Ileal Interposition and Weight Regain
Official title: Ileal Interposition to the Treatment of Weight Regain After Roux-en-Y Gastric Bypass: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
timeFrame: Change from baseline and after 3, 6, and 12 months post-surgery
measure: Change of body composition of participants after Ileal interposition surgery as measured by lean and fat mass in kilograms
timeFrame: Change from baseline and after 6 and 12 months post-surgery
measure: Change of metabolic profile of participants after Ileal interposition surgery as assessed by serum levels of glucose and insulin
timeFrame: Change from baseline and after 6 and 12 months post-surgery
measure: 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.
timeFrame: Change from baseline and after 6 months post-surgery
measure: Changes in alcohol abuse of participants after Ileal interposition surgery as reported by Alcohol Use Disorders Identification Test
timeFrame: Change from baseline and after 6 and 12 months post-surgery
measure: Changes in depressive symptoms of participants after Ileal interposition surgery as reported by Beck Depression Inventory
timeFrame: Change from baseline and after 6 and 12 months post-surgery
measure: Changes in the level of physical activity of participants after Ileal interposition surgery as reported by the International Physical Activity Questionnaire
timeFrame: Change from baseline and after 6 and 12 months post-surgery
measure: Changes in the eating disorder symptoms of participants after Ileal interposition surgery as reported by the Eating Disorder Examination Questionnaire
timeFrame: Change from baseline and after 6 and 12 months post-surgery
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: State University of Rio de Janeiro
Study officials:
affiliation: State University of Rio de Janeiro
name: Luiz Guilherme Kraemer-Aguiar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Paulo Roberto G Falcão Leal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Karynne G Grutter Lopes, PhD
role: PRINCIPAL_INVESTIGATOR
References: