Laparoscopic Ileal Interposition and Weight Regain

NCT ID: NCT05931939

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-05-01

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ileal Interposition

Interposition ileal surgery group Procedure/Surgery: Bariatric surgery

Group Type EXPERIMENTAL

Ileal Interposition

Intervention Type PROCEDURE

Bariatric surgery by laparoscopic Ileal Interposition

Traditional surgical technique

Conventional revisional surgery group Procedure/Surgery: Bariatric surgery

Group Type ACTIVE_COMPARATOR

Traditional surgical technique

Intervention Type PROCEDURE

Bariatric surgery by laparoscopic traditional technique

Interventions

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Ileal Interposition

Bariatric surgery by laparoscopic Ileal Interposition

Intervention Type PROCEDURE

Traditional surgical technique

Bariatric surgery by laparoscopic traditional technique

Intervention Type PROCEDURE

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

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Luiz Guilherme Kraemer-Aguiar, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luiz Guilherme Kraemer-Aguiar, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Paulo Roberto G Falcão Leal, MD

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Karynne G Grutter Lopes, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Locations

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State University of Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Luiz Guilherme G Kraemer-Aguiar, PhD

Role: CONTACT

+55 21 23340703

Karynne Grutter Lopes, PhD

Role: CONTACT

Facility Contacts

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Luiz Guilherme Kraemer-Aguiar, PhD

Role: primary

55212868-8212

Other Identifiers

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Ileal interposition

Identifier Type: -

Identifier Source: org_study_id

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