Laparoscopic Ileal Interposition and Weight Regain

NCT05931939 | Recruiting

• 1 other identifier: Ileal interposition
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Ileal Interposition

EXPERIMENTAL

Interposition ileal surgery group Procedure/Surgery: Bariatric surgery

Procedure: Ileal Interposition

Traditional surgical technique

ACTIVE COMPARATOR

Conventional revisional surgery group Procedure/Surgery: Bariatric surgery

Procedure: Traditional surgical technique

Interventions

Ileal Interposition PROCEDURE

Bariatric surgery by laparoscopic Ileal Interposition

Ileal Interposition

Traditional surgical technique PROCEDURE

Bariatric surgery by laparoscopic traditional technique

Traditional surgical technique

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

State University of Rio de Janeiro

Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz Guilherme G Kraemer-Aguiar, PhD

CONTACT

+55 21 23340703; lgkraemeraguiar@gmail.com

Karynne Grutter Lopes, PhD

CONTACT

kjgolrj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: July 6, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)