Back to resultsPost-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
About this trial
This is an interventional treatment trial for Parotid Neoplasms
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
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
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
Learn more about this trial
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
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