Swedish Adjustable Gastric Banding Observational Cohort Study

Obesity, Morbid Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183975
• Other study ID #: 05-FR-004
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: August 6, 2014
• Start date: September 2007
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: Ethicon Endo-Surgery (Europe) GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity, Morbid

Locations

Country	Name	City	State
France	Polyclinique Rillieux	Rillieux-La-Pape

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery (Europe) GmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean BMI Change	Mean change in BMI for valid subjects	3 years follow-up	No
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).	3 years follow up	No