Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

Veterans Affairs (VA) North Texas Health Care System

Status and phase: Completed; Phase 3

Conditions: Morbid Obesity

Treatments: Procedure: Sleeve gastrectomy; Procedure: Laparoscopic restrictive procedure

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00434525

07-011

Details and patient eligibility

About

• The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity.
• The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

Full description

This is a phase 3 prospective randomized trial.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40)
• Age > 18

Exclusion criteria

• Pregnancy
• Uncontrolled medical or psychiatric conditions
• Previous bariatric procedure

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

1 Sleeve gastrectomy with omentectomy

Experimental group

Treatment:

Procedure: Laparoscopic restrictive procedure

2 Sleeve gastrectomy

Active Comparator group

Treatment:

Procedure: Sleeve gastrectomy