Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass

Not Applicable

Terminated

• Conditions: Morbid Obesity
• Interventions: Procedure: Revision of gastric bypass

• Registration Number: NCT01116284
• Lead Sponsor: Baystate Medical Center

Brief Summary

The purpose of this study is to determine if laparoscopic plication of a gastrojejunostomy is an effective surgical option for the Roux-en-Y gastric bypass patient who has regained weight due to a dilated gastric stoma. There are several reasons postulated to be the cause in patients who regain their weight after gastric bypass, including poor diet choices, dilation of the gastric pouch and enlargement of the gastric stoma. We aim to demonstrate that laparoscopic plication of the enlarge gastrojejunostomy can provide a safe and effective method to promote increased weight loss in this subset of gastric bypass patients.

Detailed Description

Excess body weight has been shown to have many adverse health effects including, increased risk of diabetes, hypertension, joint problems and early death. Roux-en-Y gastric bypass has been shown in the literature to be an effective weight loss surgery in the majority of patients who are morbidly obese in both short and long term weight loss management. However, while 80% of patients who undergo gastric bypass lose 67-75% of their excess body weight within 2 years of surgery, 20% of patients fail to loose or regain a substantial portion of their excess body weight.1-2 There are several reasons postulated to be the cause in patients who regain their weight after gastric bypass surgery. These include poor nutritional choices and eating high caloric carbohydrates in a grazing eating pattern. Also dilation of the gastric pouch overtime which can decrease the feeling of satiety and allow for larger meals to be eaten can cause recidivism of obesity. Another problem that can occur is the enlargement of the gastrojejunostomy anastomosis. Patients who have an opening larger than 2 cm can have rapid emptying of food into the intestines and decreased satiety with meals.

Plication is a standard surgical technique of folding or tucking in, which has been used widely on other parts of the human anatomy. There have been several methods tried in the past to place plication sutures in the gastrojejunostomy from an endoluminal approach.3-7 These devices have had some success but are not widely used at this time. We aim to demonstrate that laparoscopic suture plication of the enlarged gastrojejunostomy can provide a safe and effective minimally invasive method to promote increased weight loss in this subset of gastric bypass patients who have an enlarged gastric stoma.

Specific Aim 1 To demonstrate that the laparoscopic plication of an enlarged gastric bypass is a safe surgical option to promote weight loss in the Roux-en-Y gastric bypass patient.

Specific Aim 2 To monitor the effectiveness of long term weight loss after laparoscopic plication of the gastrojejunostomy in the Roux-en-Y gastric bypass patient

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Adult male or female patients 18 to 65 years old who are able to provide informed consent for this surgical procedure
2. Patients who have previously had a laparoscopic or open Roux-en-Y gastric bypass surgery
3. Patients who have regained or failed to lose their excess body weight

Exclusion Criteria

1. Inability to provide informed consent
2. Patients who have dilated gastric pouch.
3. Patients who have a gastrogastric fistula.
4. Patients who are pregnant or plan to become pregnant during the follow up period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revision of gastric bypass	Revision of gastric bypass	A laparoscopic plication of the gastrojejunostomy will be performed after three 5-mm trocars are placed in the upper abdomen. Then using Ethibond suture, laparoscopic plication of the gastrojejunostomy on the medial, lateral and anterior surface of the anastomosis will be performed. The resulting anastomosis will be evaluated with intraoperative endoscopy and leak tested intraoperatively. The patients will be evaluated in the post-operative period with an expected discharge from the hospital within 24 hours.

Primary Outcome Measures

Name	Time	Method
Weight loss after revision of the gastric outlet	One Year	To monitor the effectiveness of long term weight loss after laparoscopic plication of the gastrojejunostomy in the Roux-en-Y gastric bypass patient

Secondary Outcome Measures

Name	Time	Method
Safety of laparoscopic plication of a gastrojejunostomy	One year	To demonstrate that the laparoscopic plication of an enlarged gastrojejunostomy is a safe surgical option to promote weight loss in the Roux-en-Y gastric bypass patient.

Trial Locations

Locations (1)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States