Swedish Adjustable Gastric Banding Observational Cohort Study
- Conditions
- Obesity, Morbid
- Registration Number
- NCT01183975
- Lead Sponsor
- Ethicon Endo-Surgery (Europe) GmbH
- Brief Summary
Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.
Verification by means of a screening log (exhaustive list of all bariatric procedures performed by participating surgeons between the beginning and end of the cohort inclusion period) requested from all centers.
No comparator group. No randomization or blinding techniques
- Detailed Description
Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.
The study is originated in collaboration with HAS in France and has a target of 500 patients treated with gastric banding because of morbid obesity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 517
- morbidly obese patients (BMI>35 with comorbidities or BMI>40 without comorbidities) in France selected for gastric banding based on standard local clinical practice
- lower BMI, contraindications based on local clinical assessment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Excess Weight Change 3 years follow up Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).
Mean BMI Change 3 years follow-up Mean change in BMI for valid subjects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Polyclinique Rillieux
🇫🇷Rillieux-La-Pape, France