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CompletedNCT00434525Updated Dec 15, 2009

Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

A Phase 3 interventional study of Laparoscopic restrictive procedure and Sleeve gastrectomy in Morbid Obesity, sponsored by North Texas Veterans Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-15.

Sponsored by North Texas Veterans Healthcare System · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
Read the detailed description

This is a phase 3 prospective randomized trial.

02

Conditions studied

  • Morbid Obesity

Keywords

  • Morbid obesity
  • Bariatric Surgery
  • Obesity Surgery
  • Omentectomy
  • Sleeve gastrectomy
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 30 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

North Texas Veterans Healthcare System is the lead sponsor of 31 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40)
  • Age > 18

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Uncontrolled medical or psychiatric conditions
  • Previous bariatric procedure
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1 Sleeve gastrectomy with omentectomy

    Procedure: Laparoscopic restrictive procedure

  • Active comparator
    2 Sleeve gastrectomy

    Procedure: Sleeve gastrectomy

Interventions

  • ProcedureLaparoscopic restrictive procedure

    Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy

  • ProcedureSleeve gastrectomy

    Sleeve gastrectomy

06

What researchers measure

Primary outcomes

  1. Weight loss

    Time frame: 5 years

Secondary outcomes

  1. Metabolic outcomes

    Time frame: 5 years

  2. Diabetes resolution

    Time frame: 5 years

07

Study locations

1 site
  • VA North Texas
    Dallas, Texas 75216, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00434525
Lead sponsor
North Texas Veterans Healthcare System
First posted
Feb 13, 2007
Start date
Jan 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Dec 15, 2009

Study contacts

Esteban Varela, MD, MPH
principal investigator · VA North Texas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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