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.

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Key information

Conditions

Parotid Neoplasms Facial Paralysis Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Paralysis Parotid Diseases Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Salivary Gland Neoplasms Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facial exercises

Behavioral

A series of self-administered facial movements and expressions.

Primary outcomes

Postoperative facial weakness

Time frame: postoperative day 1

Measure degree of facial weakness on postop day 1

Secondary outcomes

Time to resolution of facial weakness

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 18, 2015
Registry last updated: Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed