Swedish Adjustable Gastric Banding Observational Cohort Study

NCT01183975 | Completed Results DMC

• 1 other identifier: 05-FR-004
• Study Type: observational
• Target: 517
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• morbidly obese patients (BMI\>35 with comorbidities or BMI\>40 without comorbidities) in France selected for gastric banding based on standard local clinical practice

You may not qualify if:

• lower BMI, contraindications based on local clinical assessment

Sponsors & Collaborators

• Ethicon Endo-Surgery (Europe) GmbH: lead

Study Sites (1)

Polyclinique Rillieux

Rillieux-la-Pape, 69165, France

Location

Related Publications (1)

• 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.

  PMID: 25165055 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Birgit Temiz
• Organization: Ethicon, Inc.

btemiz@its.jnj.com

+49 (0) 40 5297 3144

Study Officials

• Goran Ribaric, MD,MSC,PhD

  Ethicon Endo-Surgery (Europe) GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Study Start: September 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 8, 2014
• Results First Posted: August 7, 2014

Record last verified: 2014-08

Locations

FR (1)