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Идёт набор NCT06771336

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

— Наблюдательное Head and Neck Cancers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancers. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • 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 [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 9 центров
  • University hospital of Amiens- Picardie — Amiens
  • University hospital of Lille — Lille
  • Hospices Civils de Lyon — Lyon
  • University hospital of Montpellier — Montpellier
  • University hospital of Nantes — Nantes
  • Centre Antoine Lacassagne — Nice
  • University hospital of Rouen — Rouen
  • University hospital of Toulouse — Toulouse
  • … и ещё 1 центр

Идентификаторы

NCT: NCT06771336 · RC31/24/0307 · 2024-A01597-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗