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Swedish Adjustable Gastric Banding Observational Cohort Study

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ClinicalTrials.gov Identifier: NCT01183975
Recruitment Status : Completed
First Posted : August 18, 2010
Results First Posted : August 7, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH

Study Description
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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


Condition or disease
Obesity, Morbid

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 517 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Prospective National Cohort Study on Swedish Adjustable Gastric Band (SAGB) for Gastroplasty (Étude de Cohorte Nationale Prospective de l'Implant Annulaire Ajustable Pour Gastroplastie SAGB)
Study Start Date : September 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean BMI Change [ Time Frame: 3 years follow-up ]
    Mean change in BMI for valid subjects

  2. Mean Excess Weight Change [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183975


Locations
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France
Polyclinique Rillieux
Rillieux-La-Pape, France, 69165
Sponsors and Collaborators
Ethicon Endo-Surgery (Europe) GmbH
Investigators
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Study Director: Goran Ribaric, MD,MSC,PhD Ethicon Endo-Surgery (Europe) GmbH
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier: NCT01183975    
Other Study ID Numbers: 05-FR-004
First Posted: August 18, 2010    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight