An observational study in Obesity, Morbid, sponsored by Ethicon Endo-Surgery (Europe) GmbH. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-08.
Sponsored by Ethicon Endo-Surgery (Europe) GmbH · Observational
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 517 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Ethicon Endo-Surgery (Europe) GmbH is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is that of morbidly obese patients currently treated in France by gastroplasty (gastric banding with an SAGB). The CEPP notices define the indications in which this treatment is covered by health insurance.
Exclusion Criteria:
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.
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
The cohort consisted of 517 cases of the SAGB implanted by 31 surgeons recruited between 02 SEPT 2007 and 30 April 2008.
| Milestone | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Started | 517 |
| Completed | 444 |
| Not completed | 73 |
| Withdrew: Lost to follow-up | 73 |
Mean change in BMI for valid subjects
| kg/m^2 | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Mean BMI Change | -9.03 ± 5.31 |
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).
| percent change in excess weight | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Mean Excess Weight Change | -45.76 ± 29.97 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Treated With SAGB by Solicited Teams | — | 123/517 (23.8%) | 26/517 (5%) |
| Event | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Band RemovalGastrointestinal disorders | 67/517 |
| abdominoplastySkin and subcutaneous tissue disorders | 23/517 |
| port re-interventions without port removalGastrointestinal disorders | 22/517 |
| port removalGastrointestinal disorders | 8/517 |
| band re-interventions without removalGastrointestinal disorders | 3/517 |
| Event | Patients Treated With SAGB by Solicited Teams |
|---|---|
| band-related: SlippageGastrointestinal disorders | 26/517 |
a longitudinal prospective cohort study of consecutive patients treated with SAGB in a representative sample of centers for this activity in France.
| Age, Continuous(years) | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Mean | 37.5 ± 10.92 |
| Gender(participants) | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Female | 455 |
| Male | 61 |
| Region of Enrollment(participants) | Patients Treated With SAGB by Solicited Teams |
|---|---|
| France | 517 |
| Patients treated with SAGB by solicited teams(participants) | Patients Treated With SAGB by Solicited Teams |
|---|---|
| Number | 517 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Ethicon Endo-Surgery (Europe) GmbH