Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
NCT ID: NCT04069650
Last Updated: 2019-08-28
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
70 participants
OBSERVATIONAL
2018-02-01
2018-06-30
Brief Summary
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Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.
Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.
Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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None-malnutrition
normal nutritionnal status
Free flap
Free flap reconstruction of the oral cavity
Malnutrition
* weight loss was superior to 5% in the past month;
* a weight loss was superior to 10% in the past 6 months;
* a BMI was inferior to 18,5 kg/m² (if age inferior to 70 years old) or inferior to 21 kg/m² (if age superior to \> 70 years old) - a serum albumin level inferior to 30g/L (if age inferior to 70 years old) or inferior to \<35g/L (if age superior to 70 years old).
Free flap
Free flap reconstruction of the oral cavity
Interventions
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Free flap
Free flap reconstruction of the oral cavity
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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ZWETYENGA 2018
Identifier Type: -
Identifier Source: org_study_id
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