Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Mayo Clinic76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parotid Neoplasms Facial Paralysis

Interventions

Facial exercisesBEHAVIORAL

A series of self-administered facial movements and expressions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Postoperative facial weakness

Measure degree of facial weakness on postop day 1

Time frame: postoperative day 1

Secondary Outcomes

Time to resolution of facial weakness

Monitor time to resolution of weakness in the facial exercises and control groups

Time frame: 3 months

Data from ClinicalTrials.gov

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