Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Facial Paralysis Clinical Trial

Official title:

Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527226
• Other study ID #: 15-004441
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: September 14, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Paralysis
• Paresis
• Parotid Neoplasms

Intervention

Behavioral:
• Facial exercises
A series of self-administered facial movements and expressions.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative facial weakness	Measure degree of facial weakness on postop day 1	postoperative day 1	No
Secondary	Time to resolution of facial weakness	Monitor time to resolution of weakness in the facial exercises and control groups	3 months	No