Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic Study Describing the Standard Pathway of Patients Treated by Free Bone Flap
Questionnaires: Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires
Study summary
The purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient with oral cavity cancer or maxillary and/or oropharynx cancer
* Eligible for treatment by surgery requiring a mandibulectomy or segmental maxillectomy and having a free bone flap for facial reconstruction.
* Patient whose disease is classified Stage cT4a, N0 to N3, M0
* Treatment with a feasible curative aim (no contraindication to optimal treatment such as surgery or chemotherapy at a curative dose)
* Age greater than or equal to 18 years
* Patient affiliated to a Social Security scheme in France
* Patient having given written informed consent
Non-inclusion Criteria:
* Patient having any situation considered by the doctor as a reason for non-inclusion such as stenosis of the leg tripod not allowing reconstruction by fibula, one or more comorbidity(s) not allowing reconstruction by free bone flap or making this reconstruction too much risk
* Patient having had previous radiotherapy
* Patient with severe coagulation disorders
* Patients deprived of liberty or under legal protection regime (curatorship and guardianship, safeguard of justice)
Primary outcome measure(s)
Description of the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers — 12 months The primary outcome measure is a composite endpoint consisting of the description of care pathways based on care consumption (scheduled and unscheduled hospitalizations and consultations, medical procedures and medications).
The study of pathways will take into account data from the National Health Data System (i.e. healthcare consumption).
These data will then be aggregated and structured to form time sequences representing the care pathways (and classes of care pathways) of patients using the optimal matching method. These sequences will include several medical events such as consultations, treatments, hospitalizations for example. This will provide us with a simplified but detailed representation of care trajectories. The individual care sequences thus constructed will allow us to carry out sequence analyzes aimed at creating patient clusters.
Trial sites (9)
Facility
City
Region
Status
University hospital of Amiens- Picardie
Amiens
France
Not Yet Recruiting
University hospital of Lille
Lille
France
Not Yet Recruiting
Hospices Civils de Lyon
Lyon
France
Not Yet Recruiting
University hospital of Montpellier
Montpellier
France
Not Yet Recruiting
University hospital of Nantes
Nantes
France
Not Yet Recruiting
Centre Antoine Lacassagne
Nice
France
Not Yet Recruiting
University hospital of Rouen
Rouen
France
Not Yet Recruiting
University hospital of Toulouse
Toulouse
France
Recruiting
Institut Gustave Roussy
Villejuif
France
Not Yet Recruiting
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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