Obesity, Morbid
Conditions
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.
Interventions
None listed
Sponsors
Ethicon Endo-Surgery (Europe) GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean BMI Change | 3 years follow-up | Mean change in BMI for valid subjects |
| 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). |
Countries
France
Participant flow
Recruitment details
The cohort consisted of 517 cases of the SAGB implanted by 31 surgeons recruited between 02 SEPT 2007 and 30 April 2008.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 517 |
| Total | 517 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 73 |
Baseline characteristics
| Characteristic | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 10.92 |
| Gender Female | 455 participants |
| Gender Male | 61 participants |
| Patients treated with SAGB by solicited teams | 517 participants |
| Region of Enrollment France | 517 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 517 |
| serious Total, serious adverse events | 123 / 517 |
Outcome results
Primary
Mean BMI Change
Mean change in BMI for valid subjects
Time frame: 3 years follow-up
Population: 517 valid patients analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With SAGB by Solicited Teams | Mean BMI Change | -9.03 kg/m^2 | Standard Deviation 5.31 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With SAGB by Solicited Teams | Mean Excess Weight Change | -45.76 percent change in excess weight | Standard Deviation 29.97 |