Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

NCT ID: NCT02527226

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Parotid Neoplasms Facial Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No facial exercises

This group will not receive any training in facial exercises.

Group Type NO_INTERVENTION

No interventions assigned to this group

Facial exercises

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

Group Type EXPERIMENTAL

Facial exercises

Intervention Type BEHAVIORAL

A series of self-administered facial movements and expressions.

Interventions

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Facial exercises

A series of self-administered facial movements and expressions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Eric J. Moore, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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15-004441

Identifier Type: -

Identifier Source: org_study_id

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