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临床试验/NCT02527226
NCT02527226已完成不适用

Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

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
2
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

研究组 & 干预措施

No facial exercises

No Intervention

This group will not receive any training in facial exercises.

Facial exercises

Experimental

This group will receive instruction to perform a series of self-administered exercises of facial expression and movements.

干预措施: Facial exercises (Behavioral)

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric J. Moore, M.D.

PI

Mayo Clinic

研究点 (2)

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