Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass
Primary Purpose
Morbid Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Revision of gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Weight Loss, Obesity, Gastric Bypass
Eligibility Criteria
Inclusion Criteria:
- Adult male or female patients 18 to 65 years old who are able to provide informed consent for this surgical procedure
- Patients who have previously had a laparoscopic or open Roux-en-Y gastric bypass surgery
- Patients who have regained or failed to lose their excess body weight
Exclusion Criteria:
- Inability to provide informed consent
- Patients who have dilated gastric pouch.
- Patients who have a gastrogastric fistula.
- Patients who are pregnant or plan to become pregnant during the follow up period.
Sites / Locations
- Baystate Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Revision of gastric bypass
Arm Description
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.
Outcomes
Primary Outcome Measures
Weight loss after revision of the gastric outlet
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
Safety of laparoscopic plication of a gastrojejunostomy
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01116284
Brief Title
Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass
Official Title
Laparoscopic Suture Plication of an Enlarged Gastric Stoma in the Gastric Bypass Patient
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
no patients to recruit
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baystate Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Weight Loss, Obesity, Gastric Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Revision of gastric bypass
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Revision of gastric bypass
Other Intervention Name(s)
Laparoscopic plication of gastrojejunostomy
Intervention Description
A laparoscopic operation will be performed to decrease the size of the enlarged gastric outlet. Three 5-mm laparoscopic trocars will be placed in the upper abdomen and suture 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 and are expected to be discharged from the hospital within 24 hours.
Primary Outcome Measure Information:
Title
Weight loss after revision of the gastric outlet
Description
To monitor the effectiveness of long term weight loss after laparoscopic plication of the gastrojejunostomy in the Roux-en-Y gastric bypass patient
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Safety of laparoscopic plication of a gastrojejunostomy
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female patients 18 to 65 years old who are able to provide informed consent for this surgical procedure
Patients who have previously had a laparoscopic or open Roux-en-Y gastric bypass surgery
Patients who have regained or failed to lose their excess body weight
Exclusion Criteria:
Inability to provide informed consent
Patients who have dilated gastric pouch.
Patients who have a gastrogastric fistula.
Patients who are pregnant or plan to become pregnant during the follow up period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burritt L Haag III, MD
Organizational Affiliation
Pioneer Valley Surgical Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.pvsurgical.com/
Description
Pioneer Valley Surgical Associates, P.C.
URL
http://baystatehealth.com/Baystate
Description
Baystate Medical Center
Learn more about this trial
Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass
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