Идёт набор NCT06667427

Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life

Без фазы С лечением Cancer Head and Neck Cancer

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: Nerve transfer techniques.
Кому может быть актуально: Состояния в реестре: Cancer, Head and Neck Cancer. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.

Подробное описание

Primary Objective:

To evaluate the impact of facial nerve transfer techniques (FNTT) on QoL in head and neck cancer patients with facial paralysis. This study intends to measure the impact of FNTT on QoL utilizing a series of validated questionnaires which include: (i) Facial Clinimetric Evaluation Scale and Facial Disability Index; (ii) Sunnybrook Facial Grading System; and (iii) Facial Nerve Grading Scale 2.0. These instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively.

Secondary Objective:

To compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. The same assessment tools described in primary objective above will be utilized.

Вмешательства

Процедура Nerve transfer techniques
Participants will undergo facial nerve reconstruction using nerve transfer techniques

Первичные конечные точки

Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year]

Критерии участия

Критерии включения

In order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form
Aged 18 or greater
Patient scheduled to undergo facial nerve transfer
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

In order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form
Aged 18 or greater
Previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 20 years