Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

April 25, 2008 updated by: Hadassah Medical Organization

Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss is now gaining popularity as a standalone procedure for the treatment of morbid obesity. It appears to be a technically easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good weight loss results, in some studies even comparable to the RYGB and Biliopancreatic Diversion with Duodenal Switch.

The mechanism of action is assumed to be purely restrictive, but some neurohumoral interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the medical and general quality of life or resolution of comorbidities.

The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been reported in the range that seems to be higher than for the purely restrictive procedures.

Our goal is to to compare the surgical and weight loss outcomes between the two procedures, their influence on resolution of common comorbidities and on quality of life change.

150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed evaluation and preoperative questionnaires will be used to obtain demographic and medical data, and quality of life will be assessed.

General metabolic and nutritional work up will be done, and will be reassessed at different intervals up to 5 years, in order to compare the short and long term results of the two procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with morbid obesity

Exclusion Criteria:

  • Pregnancy,
  • Previous bariatric operation,
  • IBD,
  • Previous bowel or stomach 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients who will undergo Laparoscopic Sleeve Gastrectomy
Procedure: laparoscopic operation Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy will be performed employing a 5-6 trocar technique, and includes gastric resection starting 4-5 cm proximal to the pylorus, using a 38 fr. Bougie and endoscopic stapler with blue and green load.
Active Comparator: 2
Patients who will undergo Laparoscopic Roux-en-Y Gastric Bypass
Procedure: laparoscopic operation Roux-en-Y Gastric bypass
Divided LRYGB will employ 5-7 trocars technique, and includes stapled jejunojejunostomy 30-50 cm distal to the Treitz ligament, gastric pouch of 20 cc., and antecolic, antegastric gastrojejunal anastomosis, either two layered hand-sawn, GIA, or EEA-25 -stapled, at surgeons preference. The length of the Roux limb will be 100 centimeters or 150 centimeters in patients with BMI of <50, and >50, respectively.

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
short and long term complication rates, length of stay, need for re-operations efficiency of the procedure in inducing weigh loss and resolution of common co-morbidities
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

Collaborators

Carmel Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2008

Primary Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 28, 2008

Last Update Submitted That Met QC Criteria

April 25, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBVSSG-HMO-CTIL

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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