Laparoscopic Ileal Interposition and Weight Regain

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: Ileal Interposition; Procedure: Traditional surgical technique

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luiz Guilherme G Kraemer-Aguiar, PhD; Phone Number: +55 21 23340703; Email: lgkraemeraguiar@gmail.com
• Study Contact Backup: Name: Karynne Grutter Lopes, PhD; Email: kjgolrj@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • Recruiting
    • State University of Rio de Janeiro
    • Contact: Luiz Guilherme Kraemer-Aguiar, PhD; Phone Number: 55212868-8212

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ileal Interposition; Interposition ileal surgery group Procedure/Surgery: Bariatric surgery	Procedure: Ileal Interposition; Bariatric surgery by laparoscopic Ileal Interposition
Active Comparator: Traditional surgical technique; Conventional revisional surgery group Procedure/Surgery: Bariatric surgery	Procedure: Traditional surgical technique; Bariatric surgery by laparoscopic traditional technique

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Investigators: Principal Investigator: Luiz Guilherme Kraemer-Aguiar, PhD, State University of Rio de Janeiro; Principal Investigator: Paulo Roberto G Falcão Leal, MD, State University of Rio de Janeiro; Principal Investigator: Karynne G Grutter Lopes, PhD, State University of Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Ileal interposition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No