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Swedish Adjustable Gastric Banding Observational Cohort Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier:
NCT01183975
First received: August 17, 2010
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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
Obesity, Morbid

Study Type: Observational [Patient Registry]
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery (Europe) GmbH:

Primary Outcome Measures:
  • Mean BMI Change [ Time Frame: 3 years follow-up ] [ Designated as safety issue: No ]
    Mean change in BMI for valid subjects

  • Mean Excess Weight Change [ Time Frame: 3 years follow up ] [ Designated as safety issue: No ]
    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).


Enrollment: 517
Study Start Date: September 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183975

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

No publications provided by Ethicon Endo-Surgery (Europe) GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier: NCT01183975     History of Changes
Other Study ID Numbers: 05-FR-004
Study First Received: August 17, 2010
Results First Received: April 9, 2014
Last Updated: August 6, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission

Additional relevant MeSH terms:
Obesity, Morbid
Body Weight
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014