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.
Curative management of head and neck cancers frequently requires an interrupting mandibulectomy or maxillectomy. Surgery may involve resection of anatomical structures such as jaw or maxilla. The use of free vascularized fibula or scapula flap is the "gold standard" for mandibular and maxillary reconstruction but remains suboptimal as resulting in difficulty in speaking, swallowing, and disfigurement. The BIOFACE project, funded by "Appel à Projet -Recherche Hospitalo-Universitaire en santé (RHU)" number 6 France 2023, aims to develop a new biomaterials based device to reconstruct these structure after surgery. In addition to the clinical benefits, this project aims to demonstrate the medico-economic benefits of the BIOFACE solution. Therefore, the Bioface PASS study has been designed to describe standard of care pathways of patients treated by free bone flap for facial reconstruction after surgery for head and neck cancer. Direct medical and non-medical costs, and daily allowance 12 months after the end of treatment, and quality of life will be recorded at the inclusion, 3 and 12 months. From the hospital perspectives, production costs will be recorded using the micro-costing approach.
Study Type
OBSERVATIONAL
Enrollment
200
Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires
University hospital of Amiens- Picardie
Amiens, France
NOT_YET_RECRUITINGUniversity hospital of Lille
Lille, France
NOT_YET_RECRUITINGHospices Civils de Lyon
Lyon, France
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
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.
Time frame: 12 months
Camille Dumon
CONTACT
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University hospital of Montpellier
Montpellier, France
NOT_YET_RECRUITINGUniversity hospital of Nantes
Nantes, France
NOT_YET_RECRUITINGCentre Antoine Lacassagne
Nice, France
NOT_YET_RECRUITINGUniversity hospital of Rouen
Rouen, France
NOT_YET_RECRUITINGUniversity hospital of Toulouse
Toulouse, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
NOT_YET_RECRUITING