Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass

NCT01116284 | Terminated

• 1 other identifier: BH-10-016
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Weight Loss; Obesity; Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• 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

  One Year

Secondary Outcomes (1)

• Safety of laparoscopic plication of a gastrojejunostomy

  One year

Study Arms (1)

Revision of gastric bypass

EXPERIMENTAL

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: Revision of gastric bypass

Interventions

Revision of gastric bypass PROCEDURE

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.

Also known as: Laparoscopic plication of gastrojejunostomy

Revision of gastric bypass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Links

• Pioneer Valley Surgical Associates, P.C.
• Baystate Medical Center

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Burritt L Haag III, MD

  Pioneer Valley Surgical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)