Clinical trial NCT02048033: Assessment of the Overstich Technique for the Management of Weight Regain After Gastric Bypass.
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: the Management of Weight Regain After Gastric Bypass by Endoscopic Suturing
Keywords: Obesity
Endogastric suturing
Jujenal anastomosis
weight regain
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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, ...)

Primary outcomes:
measure: Weight loss assessment of Apollo Endosurgery OverStitch technical
timeFrame: At 12 and 24 months after surgery
Secondary outcomes:
measure: Comparison of both strategies on tolerance (adverse events and serious adverse events)
timeFrame: At 12 months after Baseline and at each visit
measure: Comparison of both strategies on comorbidities
timeFrame: At 12 months after Baseline and at each visit
measure: Comparison of both strategies on quality of life
timeFrame: At 12 months after Baseline and at each visit
measure: Comparison of both strategies on medico-economic impact (drugs fees, medical consultation fees..)
timeFrame: At 12 months after Baseline and at each visit
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Lille
country: France
facility: Lille Hospital
city: Montpellier
country: France
facility: Montpellier Hospital
city: Nice
country: France
facility: Nice Hospital
city: Paris
country: France
facility: HEGP Hospital
city: Strasbourg
country: France
facility: Strasbourg Hospital
city: Villeurbanne
country: France
facility: Villeurbanne clinic
Study officials:
References: