- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02048033
Assessment of the Overstich Technique for the Management of Weight Regain After Gastric Bypass.
September 1, 2021 updated by: University Hospital, Montpellier
Medico-economic Evaluation of the Management of Weight Regain After Gastric Bypass by Gastrointestinal Narrowing of Jejunal Anastomosis by Endoscopic Suturing: Apollo Endosurgery OverStitch Technical
Prospective multicenters randomized study to compare the efficiency and the socioeconomic impact of the endoscopic management (Overstitch technique) of weight regain after gastric bypass surgery to non invasive treatment
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
Nowadays morbid obesity (BMI ≥ 40kg/m²) is a major problem of public health in industrialized countries.
About 500 000 patients would be affected by this disease in France in 2009.
Prevalence of the morbid obesity raised from 0.3 % (± 0.1 %) of the population in 1997 to 1.1 % (± 0.1 %) in 2009 (Extrapolation of the data ObEpi on 2009 to the French population) (1).
For this type of patient, the only long-term effective treatment recognized by the scientists is the bariatric surgery.
(2-4) Roux and Y Gastric Bypass (GBP) is a consensual procedure, that has been described in the sixties, in this indication (approximately 11000 GBP performed in FRance in 2012 (5,6).
This operation consists on the creation of a proximal gastric pouch (50 cc).
A Roux and Y intestinal loop will be added to create a malabsorptive part.
60 to 80 % of excess weight loss described in the literature in the long-terms.
Furthermore, improvement or remission of T2DM, sleep apnea syndrome, arterial hyperpressure, dyslipidemia) are emphasized in many trials (5, 7).
However 15 to 20 % of the handled patients present a weight regain 5 years post surgery potentially explained by the dilation of the gastric pouch or the gastro jejunal anastomosis and thus a decrease of the restrictive effect.
(8-11) To palliate this complication two solutions are described.
(12-15; 19) The first one consists in a recalibration of the gastric poouch by surgical approachy.
In this case, a ring of silicone or polypropylene can be positioned around the gastric pocket.
Other possible solution is to redo a new gastrojejunostomy with a smaller size, by surgical access (laparotomy or laparoscopy).
These interventions are very delicate because of important peritoneal adhesions and present a rate of significant morbidity especially if they are performed under laparotomy.
The pure medical care does not allow long-term results stable.
²² A therapeutic dead end is reported often for this type of patient.
A new possibility was recently described.
(17-18) A recalibration can be realized by sutures performed under endoscopic approach at the level of the gastro jejunal anastomosis or from the gastric pouch by the APOLLO Endosurgery OverStitch.
The digestive surgery by endoscopic way is rapidly expanding.
The first results seem to be promising (resumed the weight loss) but owe to be estimated in a randomized study comparing this new process with the medical conventional treatment.
A single-blind, randomized, forward-looking study, multicenter, comparative between two parallel groups of patients presenting a weight regain after GBP was thus organized.
The main objective is to estimate the efficiency of the APOLLO Endosurgery OverStitch technique versus the non-interventional strategy.
The secondary endpoints is to study the morbidity of the procedure, the evolution of quality of life of the patients, the medical economic impact of the innovation in 24 months.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Colombes, France, 92700
- Louis Mourier Hospital
-
Lille, France
- Lille Hospital
-
Montpellier, France, 34000
- Montpellier Hospital
-
Nice, France, 06000
- Nice hospital
-
Paris, France, 75015
- HEGP Hospital
-
Strasbourg, France, 67000
- Strasbourg Hospital
-
Villeurbanne, France, 69000
- Villeurbanne clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years
- Surgical criteria: patient with bariatric surgery by gastric bypass since, at least, 24 months
Clinics criteria of weight regain or treatment failure:
- Patient with weight regain> 5kg / m²
- Patient with EWL (excess weight loss) <25% after 2 years of treatment.
- Loss of early satiety (interrogation)
- Patient with a compatible psychological and cognitive status with the study,
- Patient agreeing to follow the procedures of the study and can participate at the follow-up study during 2 years
- Subject with no rights from the national health insurance programme
- Consent form signed
Exclusion criteria:
- Pregnancy (plasma assay of beta-HCG positive)
- Presence of cardiovascular, neurological, psychiatric, endocrine, renal, gastrointestinal or tumor comorbidities making irrelevant patient participation in the judgment of the investigator
- Patient participating in another clinical study or participated in another study within the last 30 days or for which the annual compensation received exceeds € 4,500
- Patient with a contre-indication to the achievement of surgery (fistula, ulceration, ...)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm with Apollo Endosurgery OverStitch technical
|
Patients will get the usual endoscopy used for diagnosis.
In addition, they will receive an endoscopic surgery using the APOLLO Endosuregery technique.
The Apollo Endosurgery OverStitch is an endoscopic equipment which involves the suturing by endogastric way to decrease the size of the anastomosis gastrojujenal or gastric pouch
|
Placebo Comparator: Arm without Apollo Endosurgery OverStitch technical
|
Patients will get the usual endoscopy used for diagnosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss assessment of Apollo Endosurgery OverStitch technical
Time Frame: At 12 and 24 months after surgery
|
The main objective is to compare the efficacy of endoscopic surgery Apollo Endosurgery OverStitch technical than the conventional non-interventional strategy in patients with weight regain after gastric bypass.Moreover, all of these patients will also benefit from the medical-nutritional usual care.
|
At 12 and 24 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of both strategies on tolerance (adverse events and serious adverse events)
Time Frame: At 12 months after Baseline and at each visit
|
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on tolerance and safety related to obesity.
|
At 12 months after Baseline and at each visit
|
Comparison of both strategies on comorbidities
Time Frame: At 12 months after Baseline and at each visit
|
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on comorbidities related to obesity (type 2 diabetes, arterial hypertension, sleep apnea syndrome, ...).
|
At 12 months after Baseline and at each visit
|
Comparison of both strategies on quality of life
Time Frame: At 12 months after Baseline and at each visit
|
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on quality of life.
|
At 12 months after Baseline and at each visit
|
Comparison of both strategies on medico-economic impact (drugs fees, medical consultation fees..)
Time Frame: At 12 months after Baseline and at each visit
|
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on medico-economic impact of innovation. Moreover, a cost-effectiveness analysis will be performed at the end of this study. |
At 12 months after Baseline and at each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
April 11, 2017
Study Registration Dates
First Submitted
January 16, 2014
First Submitted That Met QC Criteria
January 24, 2014
First Posted (Estimate)
January 29, 2014
Study Record Updates
Last Update Posted (Actual)
September 10, 2021
Last Update Submitted That Met QC Criteria
September 1, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on the Management of Weight Regain After Gastric Bypass by Endoscopic Suturing
-
Women and Infants Hospital of Rhode IslandUnknownManagement of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.United States
Clinical Trials on Regular endoscopy + endogastric suturing
-
C. R. BardTerminated
-
RenJi HospitalThe First Affiliated Hospital with Nanjing Medical University; Fudan University and other collaboratorsNot yet recruitingHypoxia | Esophageal Cancer | Colon Cancer | Gastric PolypChina
-
Cleveland Clinic LondonRecruitingObesity | Diabetes Mellitus, Type 2United Kingdom