Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
FOOD
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedAugust 28, 2019
August 1, 2019
4 months
August 23, 2019
August 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Major complication occurency
in the first-month post-operative period, complications leading to flap loss
1 month
Secondary Outcomes (1)
Minor complication occurency
1 month
Study Arms (2)
None-malnutrition
normal nutritionnal status
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).
Interventions
Eligibility Criteria
patients undergoing free flap reconstruction of the oral cavity
You may qualify if:
- every consenting patients undergoing free flap reconstruction of the oral cavity
You may not qualify if:
- unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Dijon Bourgogne
Dijon, 21000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
February 1, 2018
Primary Completion
May 31, 2018
Study Completion
June 30, 2018
Last Updated
August 28, 2019
Record last verified: 2019-08