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

August 17, 2010
August 6, 2014
September 2007
April 2012   (final data collection date for primary outcome measure)
  • 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).
Not Provided
Complete list of historical versions of study NCT01183975 on ClinicalTrials.gov Archive Site
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Swedish Adjustable Gastric Banding Observational Cohort Study
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)

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
36 Months
Not Provided
Probability Sample

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.

Obesity, Morbid
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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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
517
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01183975
05-FR-004
Yes
Ethicon Endo-Surgery (Europe) GmbH
Ethicon Endo-Surgery (Europe) GmbH
Not Provided
Study Director: Goran Ribaric, MD,MSC,PhD Ethicon Endo-Surgery (Europe) GmbH
Ethicon Endo-Surgery (Europe) GmbH
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP