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Clinical Trials/NCT02527226
NCT02527226CompletedNot Applicable

Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Mayo Clinic4 sites in 1 country76 target enrollmentStarted: August 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
4
Primary Endpoint
Postoperative facial weakness
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Postoperative facial weakness

Time Frame: postoperative day 1

Measure degree of facial weakness on postop day 1

Secondary Outcomes

  • Time to resolution of facial weakness(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric J. Moore, M.D.

PI

Mayo Clinic

Study Sites (4)

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