Free Flap ReconstructionFOODNCT04069650
Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
An observational study of Free Flap Reconstruction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Free Flap Reconstruction
- What is being tested?
- Free flap
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing free flap reconstruction of the oral cavity
Who may be able to join
- every consenting patients undergoing free flap reconstruction of the oral cavity
Who cannot join
- unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Free Flap Reconstruction
- Being tested
- Free flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free flapProcedure or surgery
Free flap reconstruction of the oral cavity
| Study group | Role | What they receive |
|---|---|---|
| None-malnutrition | normal nutritionnal status Receives: Procedure: Free flap | |
| 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). Receives: Procedure: Free flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication occurency
in the first-month post-operative period, complications leading to flap loss
Measured: 1 month
Secondary outcomes (1)
Minor complication occurency
in the first-month post-operative period, complications NOT leading to flap loss
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Feb 2018
- Primary completion31 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Flap ReconstructionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069650
- Sponsor's protocol ID
- ZWETYENGA 2018
- Acronym
- FOOD
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
- ClinicalTrials.gov ID
- NCT04069650
- Acronym / sponsor ID
- FOOD / ZWETYENGA 2018
- Conditions
- Free Flap Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| None-malnutrition | – | Procedure: Free flapnormal nutritionnal status |
| Malnutrition | – | Procedure: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing free flap reconstruction of the oral cavity
Key inclusion criteria (1 listed)
- every consenting patients undergoing free flap reconstruction of the oral cavity
Key exclusion criteria (1 listed)
- unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free flapFree flap reconstruction of the oral cavity | Procedure or surgery | Malnutrition, None-malnutrition |
Primary outcome
Major complication occurency
Time frame: 1 month
in the first-month post-operative period, complications leading to flap loss
1 secondary outcome
Minor complication occurency
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Free Flap Reconstruction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complication occurency (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.