RecruitingNCT06771336

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

Standard of Care Pathways Evaluation of Patients Treated for Facial Reconstruction After Surgery for Head and Neck Cancer, Using the Conventional Technique (Free Bone Flap): a Medico-economic Study


Sponsor

University Hospital, Toulouse

Enrollment

200 participants

Start Date

Sep 3, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria11

  • 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
  • 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)

Interventions

OTHERQuestionnaires

Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires


Locations(9)

University hospital of Amiens- Picardie

Amiens, France

University hospital of Lille

Lille, France

Hospices Civils de Lyon

Lyon, France

University hospital of Montpellier

Montpellier, France

University hospital of Nantes

Nantes, France

Centre Antoine Lacassagne

Nice, France

University hospital of Rouen

Rouen, France

University hospital of Toulouse

Toulouse, France

Institut Gustave Roussy

Villejuif, France

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NCT06771336


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