Laparoscopic Ileal Interposition and Weight Regain

Rio de Janeiro State University

Status: Enrolling

Conditions: Obesity

Treatments: Procedure: Ileal Interposition; Procedure: Traditional surgical technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05931939

Ileal interposition

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Ileal Interposition

Experimental group

Description:

Interposition ileal surgery group Procedure/Surgery: Bariatric surgery

Treatment:

Procedure: Ileal Interposition

Traditional surgical technique

Active Comparator group

Description:

Conventional revisional surgery group Procedure/Surgery: Bariatric surgery

Treatment:

Procedure: Traditional surgical technique