Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass

This study has been terminated.
(no patients to recruit)
Sponsor:
Information provided by (Responsible Party):
Dr. Burritt Haag, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01116284
First received: May 3, 2010
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Morbid Obesity
Procedure: Laparoscopic plication of an enlarged gastrojejunostomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Suture Plication of an Enlarged Gastric Stoma in the Gastric Bypass Patient

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • Weight loss after revision of the gastric outlet [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 5
Study Start Date: April 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plication of a gastric outlet
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.
Procedure: Laparoscopic plication of an enlarged gastrojejunostomy
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.
Other Name: Revision of gastric bypass

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116284

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Burritt L Haag III, MD Pioneer Valley Surgical Associates
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Burritt Haag, Principal Investigator, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01116284     History of Changes
Other Study ID Numbers: BH-10-016
Study First Received: May 3, 2010
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Weight Loss
Obesity
Gastric Bypass

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014