Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients known to be pregnant
研究组 & 干预措施
Control
Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery.
干预措施: Nerve transfer techniques (Procedure)
Surgery
干预措施: Nerve transfer techniques (Procedure)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点