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

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.

Study Overview

• Status: Completed
• Conditions: Free Flap Reconstruction
• Intervention / Treatment: Procedure: Free flap

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing free flap reconstruction of the oral cavity

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unable to give consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complication occurency	in the first-month post-operative period, complications leading to flap loss	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor complication occurency	in the first-month post-operative period, complications NOT leading to flap loss	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: ZWETYENGA 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No