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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic restrictive procedure
Sleeve gastrectomy
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Bariatric Surgery, Obesity Surgery, Omentectomy, Sleeve gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA North Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 Sleeve gastrectomy with omentectomy

2 Sleeve gastrectomy

Arm Description

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Metabolic outcomes
Diabetes resolution

Full Information

First Posted
February 9, 2007
Last Updated
December 14, 2009
Sponsor
North Texas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT00434525
Brief Title
Laparoscopic Sleeve Gastrectomy With and Without Omentectomy
Official Title
Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Texas Veterans Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
This is a phase 3 prospective randomized trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid obesity, Bariatric Surgery, Obesity Surgery, Omentectomy, Sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 Sleeve gastrectomy with omentectomy
Arm Type
Experimental
Arm Title
2 Sleeve gastrectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic restrictive procedure
Intervention Description
Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
Sleeve gastrectomy
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Metabolic outcomes
Time Frame
5 years
Title
Diabetes resolution
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esteban Varela, MD, MPH
Organizational Affiliation
VA North Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

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