Clinical trial NCT00394212: Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Keywords: Weight Loss
Transoral Suturing
Dilated gastrojejunostomy
Inadequate weight loss following primary RYGB
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Weight Loss (%)
timeFrame: 6 months
Secondary outcomes:
measure: Subjects Achieving 15% Excess Weight Loss (EWL)
timeFrame: 6 months
measure: Subjects Achieving Weight Stabilization at 6 Months
timeFrame: 6 months
measure: Subjects Achieving 20% Excess Weight Loss at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References:
citation: Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.