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

Completed

• Conditions: Free Flap Reconstruction
• Interventions: Procedure: Free flap

• Registration Number: NCT04069650
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-06-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Last Update Submitted: 2019-08-23
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
None-malnutrition	Free flap	normal nutritionnal status
Malnutrition	Free flap	* 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).

Primary Outcome Measures

Name	Time	Method
Major complication occurency	1 month	in the first-month post-operative period, complications leading to flap loss

Secondary Outcome Measures

Name	Time	Method
Minor complication occurency	1 month	in the first-month post-operative period, complications NOT leading to flap loss

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France