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Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

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Mayo Clinic

Status

Completed

Conditions

Parotid Neoplasms
Facial Paralysis

Treatments

Behavioral: Facial exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT02527226
15-004441

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

No facial exercises
No Intervention group
Description:
This group will not receive any training in facial exercises.
Facial exercises
Experimental group
Description:
This group will receive instruction to perform a series of self-administered exercises of facial expression and movements.
Treatment:
Behavioral: Facial exercises

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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