Facial Paralysis, Parotid Neoplasms
Conditions
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.
Interventions
BEHAVIORALFacial exercises
A series of self-administered facial movements and expressions.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative facial weakness | postoperative day 1 | Measure degree of facial weakness on postop day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution of facial weakness | 3 months | Monitor time to resolution of weakness in the facial exercises and control groups |
Countries
United States
Outcome results
None listed