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Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Primary Purpose

Parotid Neoplasms, Facial Paralysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facial exercises
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parotid Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic in Arizona
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No facial exercises

Facial exercises

Arm Description

This group will not receive any training in facial exercises.

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

Outcomes

Primary Outcome Measures

Postoperative facial weakness
Measure degree of facial weakness on postop day 1

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2015
Last Updated
September 14, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02527226
Brief Title
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
Official Title
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotid Neoplasms, Facial Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No facial exercises
Arm Type
No Intervention
Arm Description
This group will not receive any training in facial exercises.
Arm Title
Facial exercises
Arm Type
Experimental
Arm Description
This group will receive instruction to perform a series of self-administered exercises of facial expression and movements.
Intervention Type
Behavioral
Intervention Name(s)
Facial exercises
Intervention Description
A series of self-administered facial movements and expressions.
Primary Outcome Measure Information:
Title
Postoperative facial weakness
Description
Measure degree of facial weakness on postop day 1
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
Time to resolution of facial weakness
Description
Monitor time to resolution of weakness in the facial exercises and control groups
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Moore, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

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