Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

NCT ID: NCT00434525

Last Updated: 2009-12-15

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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* 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.

Detailed Description

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This is a phase 3 prospective randomized trial.

Conditions

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Morbid Obesity

Keywords

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Morbid obesity Bariatric Surgery Obesity Surgery Omentectomy Sleeve gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Sleeve gastrectomy with omentectomy

Group Type EXPERIMENTAL

Laparoscopic restrictive procedure

Intervention Type PROCEDURE

Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy

2 Sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

Sleeve gastrectomy

Interventions

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Laparoscopic restrictive procedure

Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy

Intervention Type PROCEDURE

Sleeve gastrectomy

Sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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VA North Texas

Principal Investigators

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Esteban Varela, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

VA North Texas

Locations

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VA North Texas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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07-011

Identifier Type: -

Identifier Source: org_study_id