Morbid ObesityNCT01116284
Laparoscopic Revision of an Enlarged Gastric Outlet After Gastric Bypass
A study testing Revision of gastric bypass in people with Morbid Obesity, run by Baystate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Revision of gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Laparoscopic Suture Plication of an Enlarged Gastric Stoma in the Gastric Bypass Patient
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.
Read the 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
- Conditions
- Morbid Obesity
- Being tested
- Revision of gastric bypass
- Keywords
- Weight Loss, Obesity, Gastric Bypass
- Medical subject headings
- Obesity, Morbid, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision of gastric bypassProcedure or surgery
Also called Laparoscopic plication of 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Revision of gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One Year
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: no patients to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burritt L Haag III, MD, Principal investigator, Pioneer Valley Surgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116284
- Sponsor's protocol ID
- BH-10-016
- Status last verified
- Aug 2016
- First submitted
- 3 May 2010
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Suture Plication of an Enlarged Gastric Stoma in the Gastric Bypass Patient
- ClinicalTrials.gov ID
- NCT01116284
- Acronym / sponsor ID
- BH-10-016
- Conditions
- Morbid Obesity
- Keywords
- Weight Loss, Obesity, Gastric Bypass
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no patients to recruit
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision of gastric bypass | Experimental | Procedure: Revision of gastric bypassA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revision of gastric bypassAlso: Laparoscopic plication of gastrojejunostomyA 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. | Procedure or surgery | Revision of gastric bypass |
Primary outcome
Weight loss after revision of the gastric outlet
Time frame: 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
1 secondary outcome
Safety of laparoscopic plication of a gastrojejunostomy
Time frame: One year
Results and safety
The study was stopped early (reason given: no patients to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Pioneer Valley Surgical Associates, P.C.Link provided by the sponsor.
- Baystate Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burritt L Haag III, MD principal investigator
Pioneer Valley Surgical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revision of gastric bypass in people with Morbid Obesity, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no patients to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss after revision of the gastric outlet (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.