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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01475903 |
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Date of registration:
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18/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of Nutritional Consequences of Sleeve Gastrectomy
ERNEST |
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Scientific title:
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Assessment of Nutritional Consequences of Sleeve Gastrectomy |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01475903 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Julie LEGER-GUIST'HAU, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 18 and 65 years
- Initial BMI = 35
- Proposition of a sleeve gastrectomy during a multidisciplinary consultation
- Bariatric surgery procedure carried out at the University Hospital of Clermont-
Ferrand.
- Patient covered by the national health insurance scheme
- Patient having read, understood and signed the information sheet and the consent form
Exclusion Criteria:
- History of pathology or major surgical procedure which could interfere with the
nutritional state and other study parameters (cancer, DID, digestive pathology,
infectious or inflammatory disease)
- Pregnant or breast-feeding women
- Existence of cognitive disorders which could interfere with compliance of the study
- Person deprived of judicial or administrative freedom
- Participation in another study
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Procedure: Longitudinal sleeve gastrectomy
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Primary Outcome(s)
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micro nutritional status of patients undergoing sleeve gastrectomy
[Time Frame: at 3, 6, 12, 18 and 24 months after intervention]
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Secondary Outcome(s)
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arterial blood pressure
[Time Frame: at 3, 6, 12, 18 and 24 months]
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questionnaire SF-36
[Time Frame: at 6 months after the operation]
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lipid assessment
[Time Frame: at 3, 6, 12, 18 and 24 months]
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arthropathy estimated clinically
[Time Frame: at 3, 6, 12, 18 and 24 months]
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HOMA test
[Time Frame: at 3, 6, 12, 18 and 24 months]
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physical composition measured by impedancemetry
[Time Frame: at 3, 6, 12, 18 and 24 months]
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Secondary ID(s)
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CHU-0093
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2010-A00406-33
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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