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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean BMI Change | Mean change in BMI for valid subjects | 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). | 3 years follow up |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Goran Ribaric, MD,MSC,PhD | Ethicon Endo-Surgery (Europe) GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Rillieux | Rillieux-la-Pape | 69165 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25165055 | Derived | Ribaric G, Buchwald J. Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients. Croat Med J. 2014 Aug 28;55(4):405-15. doi: 10.3325/cmj.2014.55.405. |
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The cohort consisted of 517 cases of the SAGB implanted by 31 surgeons recruited between 02 SEPT 2007 and 30 April 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
a longitudinal prospective cohort study of consecutive patients treated with SAGB in a representative sample of centers for this activity in France.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean BMI Change | Mean change in BMI for valid subjects | 517 valid patients analyzed | Posted | Mean | Standard Deviation | kg/m^2 | 3 years follow-up |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Band Removal | Gastrointestinal disorders | Non-systematic Assessment | Band Removal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| band-related: Slippage | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birgit Temiz | Ethicon, Inc. | +49 (0) 40 5297 3144 | btemiz@its.jnj.com |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Patients treated with SAGB by solicited teams | Number | participants |
|
|
| 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). | Posted | Mean | Standard Deviation | percent change in excess weight | 3 years follow up |
|
|
|
| 123 |
| 517 |
| 26 |
| 517 |
| abdominoplasty | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Abdominoplasty |
|
| port re-interventions without port removal | Gastrointestinal disorders | Non-systematic Assessment | port re-interventions without port removal |
|
| port removal | Gastrointestinal disorders | Non-systematic Assessment | Port Removal |
|
| band re-interventions without removal | Gastrointestinal disorders | Non-systematic Assessment | band re-interventions without removal |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |