Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

November 1, 2007 updated by: Legacy Health System
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • United States
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Oregon Weight Loss Surgery LLC
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing laparoscopic gastric bypass, >18 yo, understands english

Exclusion Criteria:

  • previous lower pelvic surgery, self-pay patients, previous weight loss surgery,

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
surgery plus omentectomy
Procedure: laparoscopic gastric bypass plus omentectomy
No Intervention: 2
standard gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diabetic indices
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
interleukin and cytokine levels, weight loss
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Legacy Health System

Investigators

  • Principal Investigator: Dennis Hong, MD., MS.c, FRCSC, Oregon Weight Loss Surgery, LLC

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

July 1, 2006

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2007

Last Update Submitted That Met QC Criteria

November 1, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1234 (Department of Defense)

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.

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