Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

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 Overview

• Status: Completed
• Conditions: Facial Paralysis; Parotid Neoplasms
• Intervention / Treatment: Behavioral: Facial exercises

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative facial weakness	Measure degree of facial weakness on postop day 1	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of facial weakness	Monitor time to resolution of weakness in the facial exercises and control groups	3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Eric Moore, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Disease Attributes; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Salivary Gland Diseases; Facial Nerve Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Paralysis; Paresis; Bell Palsy; Facial Paralysis; Facies; Parotid Neoplasms
• Other Study ID Numbers: 15-004441