Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss
NCT ID: NCT01469962
Last Updated: 2014-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2011-11-30
2014-02-28
Brief Summary
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The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a population of patients operated on for morbid obesity ( BMI \> 40kg/m2 or BMI\> 35kg/m2 with comorbidity). The primary end point is to evaluate the concordance between Fibrotest and transthyretin serum levels. The number of patients has been calculated on the basis of a concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in this study. According to the number of patients operated on in the 3 centres (\>150/year), the time for recruitment is 12 months. Secondary end points will evaluate in these patients the excess weight loss, the improvement in fibrosis liver tests and the correlation with improvement in other obesity- related conditions, according to surgical procedures.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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obese patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Amiens University Hospital
OTHER
University Hospital, Rouen
OTHER
Responsible Party
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Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2010/079/HP
Identifier Type: -
Identifier Source: org_study_id
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