Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass - Full Text View

Purpose

It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.

For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.

The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.

Condition	Intervention	Phase
Obesity	Device: Transoral Suturing	Phase III

MedlinePlus related topics:

Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery

Further study details as provided by C. R. Bard:

Primary Outcome Measures:

Weight Loss [ Time Frame: 6 months ]

Secondary Outcome Measures:

Excess Weight Lost (EWL) [ Time Frame: 6 months ]
Weight Stabilization [ Time Frame: 6 months ]
Improvement in Comorbidities and Quality of Life Parameters [ Time Frame: 6 months ]

Estimated Enrollment:	230
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental transoral suturing	Device: Transoral Suturing suturing of anastomosis
2: Sham Comparator suturing not performed	Device: Transoral Suturing suturing of anastomosis

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

6 months post primary RYGB with inadequate weight loss or weight regain
BMI >30 and ≤ 50
Dilated gastrojejunal anastomosis
Successfully completes screening process
Signed consent

Exclusion Criteria:

Recently quit smoking or plan to quit within the next year
Pregnant or planning to become pregnant over the course of the next 9 months
Mallampati score of 4
Serious systemic disease or active disease of the gastrointestinal tract
Gastric pouch abnormalities
Significant movement limitations
Use of weight-promoting or weight-reduction drugs during study period
Severe eating disorders
Uncontrolled depression or psychoses
Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
History of significant cardiovascular, cerebrovascular or pulmonary disease
Not a candidate for conscious or general sedation
Anticoagulant therapies
Active substance abuse
Life expectancy < 1 year
Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394212

Locations


United States, Colorado

	Denver, Colorado, United States

United States, Maryland

	Baltimore, Maryland, United States

United States, Massachusetts

	Boston, Massachusetts, United States

United States, Missouri

	St. Louis, Missouri, United States

United States, New Hampshire

	Lebanon, New Hampshire, United States

United States, New York

	New York, New York, United States

United States, Ohio

	Cleveland, Ohio, United States

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States

United States, Texas

	Dallas, Texas, United States

United States, Wisconsin

	Milwaukee, Wisconsin, United States

Sponsors and Collaborators

C. R. Bard

More Information

Study ID Numbers:	DVL-EC-002
First Received:	October 27, 2006
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00394212
Health Authority:	United States: Food and Drug Administration

Keywords provided by C. R. Bard:

Weight Loss

Transoral Suturing

Dilated gastrojejunostomy

Inadequate weight loss following primary RYGB

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Weight Loss

Body Weight Changes

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	C. R. Bard
Information provided by:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT00394212