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

NCT ID: NCT04069650

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Free Flap Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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None-malnutrition

normal nutritionnal status

Free flap

Intervention Type PROCEDURE

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).

Free flap

Intervention Type PROCEDURE

Free flap reconstruction of the oral cavity

Interventions

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Free flap

Free flap reconstruction of the oral cavity

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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ZWETYENGA 2018

Identifier Type: -

Identifier Source: org_study_id

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