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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

This study has been completed.
Sponsor:
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00434525
First received: February 9, 2007
Last updated: December 14, 2009
Last verified: August 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Sleeve gastrectomy with omentectomy Procedure: Laparoscopic restrictive procedure
Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
Active Comparator: 2 Sleeve gastrectomy 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

Locations
United States, Texas
VA North Texas
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Esteban Varela, MD, MPH VA North Texas
  More Information

No publications provided

Responsible Party: Esteban Varela MD, MPH, VA North Texas
ClinicalTrials.gov Identifier: NCT00434525     History of Changes
Other Study ID Numbers: 07-011
Study First Received: February 9, 2007
Last Updated: December 14, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013