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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2008 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Carmel Medical Center

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00667706

First received: April 16, 2008

Last updated: April 25, 2008

Last verified: April 2008

History of Changes

Purpose

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.

Condition	Intervention	Phase
Morbid Obesity	Procedure: laparoscopic operation Sleeve Gastrectomy Procedure: laparoscopic operation Roux-en-Y Gastric bypass	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with morbid obesity

Exclusion Criteria:

Pregnancy,
Previous bariatric operation,
IBD,
Previous bowel or stomach surgery

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Andrei Keidar, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00667706 History of Changes
Other Study ID Numbers:	GBVSSG-HMO-CTIL
Study First Received:	April 16, 2008
Last Updated:	April 25, 2008
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

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