Swedish Adjustable Gastric Banding Observational Cohort Study

Ethicon

Status: Completed

Conditions: Obesity, Morbid

Study type: Observational

Funder types: Industry

Identifiers

NCT01183975

05-FR-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 517 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

517 participants in 1 patient group

Patients treated with SAGB by solicited teams

Description:

Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.