Laparoscopic Sleeve Gastrectomy With and Without Omentectomy
December 14, 2009 updated by: North Texas Veterans Healthcare System
Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a phase 3 prospective randomized trial.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75216
- VA North Texas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1 Sleeve gastrectomy with omentectomy
|
Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
|
|
ACTIVE_COMPARATOR: 2 Sleeve gastrectomy
|
Sleeve gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight loss
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Metabolic outcomes
Time Frame: 5 years
|
5 years
|
|
Diabetes resolution
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Esteban Varela, MD, MPH, VA North Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
February 9, 2007
First Submitted That Met QC Criteria
February 9, 2007
First Posted (ESTIMATE)
February 13, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
December 15, 2009
Last Update Submitted That Met QC Criteria
December 14, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-011 (OTHER: Fox Chase Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.