Assessment of the Overstich Technique for the Management of Weight Regain After Gastric Bypass.

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT02048033
• Date of registration: 16/01/2014
• Prospective Registration: No
• Primary sponsor: University Hospital, Montpellier
• Public title: Assessment of the Overstich Technique for the Management of Weight Regain After Gastric Bypass.
• Scientific 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
• Date of first enrolment: January 3, 2014
• Target sample size: 74
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02048033
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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,
...)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

the Management of Weight Regain After Gastric Bypass by Endoscopic Suturing

Intervention(s)

Diagnostic Test: Regular endoscopy

Device: Regular endoscopy + endogastric suturing

Primary Outcome(s)

Weight loss assessment of Apollo Endosurgery OverStitch technical [Time Frame: At 12 and 24 months after surgery]

Secondary Outcome(s)

Comparison of both strategies on quality of life [Time Frame: 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]

Comparison of both strategies on medico-economic impact (drugs fees, medical consultation fees..) [Time Frame: At 12 months after Baseline and at each visit]

Comparison of both strategies on tolerance (adverse events and serious adverse events) [Time Frame: At 12 months after Baseline and at each visit]

Secondary ID(s)

5037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors