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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Free Flap Reconstruction

Treatments: Procedure: Free flap

Study type: Observational

Funder types: Other

Identifiers

NCT04069650

ZWETYENGA 2018

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• unable to give consent

Trial design

70 participants in 2 patient groups

None-malnutrition

Description:

normal nutritionnal status

Treatment:

Procedure: Free flap

Malnutrition

Description:

* 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).

Treatment:

Procedure: Free flap