NCT02527226已完成不适用
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Postoperative facial weakness
研究概览
简要总结
This is a protocol to govern the prospective trial of facial nerve monitoring in patients undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor provides useful information to operating surgeons and if the information provided by the facial nerve monitor can predict degrees of postoperative facial nerve paresis.
Additionally, the study will determine if performing daily facial rehabilitation exercises provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •18 years of age or older
- •Planned parotid gland surgery (superficial or total parotidectomy)
- •Benign or malignant disease
排除标准
- •Pregnancy
- •Preoperative facial nerve dysfunction
- •Revision operation
- •History of preoperative radiation to the surgical field
- •Entire nerve not dissected
- •Intentional nerve sacrifice
- •Poor signal to noise ratio during surgery
- •Lack of access to device compatible with video conferencing software, or lack of access to broadband internet connection
结局指标
主要结局
Postoperative facial weakness
时间窗: postoperative day 1
Measure degree of facial weakness on postop day 1
次要结局
- Time to resolution of facial weakness(3 months)
研究者
研究点 (4)
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