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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

This study is currently recruiting participants.
Verified by North Texas Veterans' Healthcare System, August 2008

Sponsored by: North Texas Veterans' Healthcare System
Information provided by: North Texas Veterans' Healthcare System
ClinicalTrials.gov Identifier: NCT00434525
  Purpose
  • 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.

Condition Intervention Phase
Morbid Obesity
Procedure: Laparoscopic restrictive procedure
Procedure: Sleeve gastrectomy
Phase III

MedlinePlus related topics:   Obesity   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial

Further study details as provided by North Texas Veterans' Healthcare System:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Diabetes resolution [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   January 2008
Estimated Study Completion Date:   December 2012
Estimated Primary Completion Date:   December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Sleeve gastrectomy with omentectomy: Experimental Procedure: Laparoscopic restrictive procedure
Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
2 Sleeve gastrectomy: Active Comparator Procedure: Sleeve gastrectomy
Sleeve gastrectomy

Detailed Description:

This is a phase 3 prospective randomized trial.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434525

Contacts
Contact: Tammy Nguyen, MT     214-857-1521     tammy.nguyen@va.gov    

Locations
United States, Texas
VA North Texas     Recruiting
      Dallas, Texas, United States, 75216
      Contact: Tammy Nguyen, MT     214-857-1521     tammy.nguyen@va.gov    
      Principal Investigator: Esteban Varela, MD            

Sponsors and Collaborators
North Texas Veterans' Healthcare System

Investigators
Principal Investigator:     Esteban Varela, MD, MPH     VA North Texas    
  More Information

American College of Surgeons Surgery News  This link exits the ClinicalTrials.gov site
 

Responsible Party:   VA North Texas ( Esteban Varela MD, MPH )
Study ID Numbers:   07-011
First Received:   February 9, 2007
Last Updated:   August 25, 2008
ClinicalTrials.gov Identifier:   NCT00434525
Health Authority:   United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:
Morbid obesity  
Bariatric Surgery  
Obesity Surgery  
Omentectomy  
Sleeve gastrectomy  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on September 05, 2008




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