Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Not Applicable

Completed

• Conditions: Parotid Neoplasms; Facial Paralysis

• Registration Number: NCT02527226
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• 18 years of age or older
• Planned parotid gland surgery (superficial or total parotidectomy)
• Benign or malignant disease

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative facial weakness	postoperative day 1	Measure degree of facial weakness on postop day 1

Secondary Outcome Measures

Name	Time	Method
Time to resolution of facial weakness	3 months	Monitor time to resolution of weakness in the facial exercises and control groups

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States