Clinical Trials Directory

Trials / Completed

CompletedNCT04069650

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

Status
Completed
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREFree flapFree flap reconstruction of the oral cavity

Timeline

Start date
2018-02-01
Primary completion
2018-05-31
Completion
2018-06-30
First posted
2019-08-28
Last updated
2019-08-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04069650. Inclusion in this directory is not an endorsement.