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Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity (FOOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069650
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

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.


Condition or disease Intervention/treatment
Free Flap Reconstruction Procedure: Free flap

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
None-malnutrition
normal nutritionnal status
Procedure: 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).
Procedure: Free flap
Free flap reconstruction of the oral cavity




Primary Outcome Measures :
  1. Major complication occurency [ Time Frame: 1 month ]
    in the first-month post-operative period, complications leading to flap loss


Secondary Outcome Measures :
  1. Minor complication occurency [ Time Frame: 1 month ]
    in the first-month post-operative period, complications NOT leading to flap loss



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing free flap reconstruction of the oral cavity
Criteria

Inclusion Criteria:

  • every consenting patients undergoing free flap reconstruction of the oral cavity

Exclusion Criteria:

  • unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069650


Locations
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France
Chu Dijon Bourgogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04069650    
Other Study ID Numbers: ZWETYENGA 2018
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders