Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
1 other identifier
interventional
76
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 16, 2016
September 1, 2016
11 months
August 17, 2015
September 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative facial weakness
Measure degree of facial weakness on postop day 1
postoperative day 1
Secondary Outcomes (1)
Time to resolution of facial weakness
3 months
Study Arms (2)
No facial exercises
NO INTERVENTIONThis group will not receive any training in facial exercises.
Facial exercises
EXPERIMENTALThis group will receive instruction to perform a series of self-administered exercises of facial expression and movements.
Interventions
A series of self-administered facial movements and expressions.
Eligibility Criteria
You may qualify if:
- years of age or older
- Planned parotid gland surgery (superficial or total parotidectomy)
- Benign or malignant disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Moore, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 18, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 16, 2016
Record last verified: 2016-09