Swedish Adjustable Gastric Banding Observational Cohort Study

Ethicon Endo-Surgery (Europe) GmbH517 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

517

Conditions

Obesity, Morbid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * morbidly obese patients (BMI\>35 with comorbidities or BMI\>40 without comorbidities) in France selected for gastric banding based on standard local clinical practice Exclusion Criteria: * lower BMI, contraindications based on local clinical assessment

Locations (1)

Polyclinique Rillieux

Rillieux-la-Pape, France

Outcomes

Primary Outcomes

Mean BMI Change

Mean change in BMI for valid subjects

Time frame: 3 years follow-up

Mean Excess Weight Change

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).

Time frame: 3 years follow up

Data from ClinicalTrials.gov

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