Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02527226

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parotid Neoplasms Facial Paralysis	Behavioral: Facial exercises	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No facial exercises This group will not receive any training in facial exercises.
Experimental: Facial exercises This group will receive instruction to perform a series of self-administered exercises of facial expression and movements.	Behavioral: Facial exercises A series of self-administered facial movements and expressions.

Arm

Intervention/Treatment

No Intervention: No facial exercises

This group will not receive any training in facial exercises.

Experimental: Facial exercises

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

Behavioral: Facial exercises

A series of self-administered facial movements and expressions.

Outcome Measures

Primary Outcome Measures

Postoperative facial weakness [postoperative day 1]
Measure degree of facial weakness on postop day 1

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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