Swedish Adjustable Gastric Banding Observational Cohort Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients treated with SAGB by solicited teams

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.

No interventions assigned to this group

Eligibility Criteria

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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