Post-parotidectomy Facial Paresis: Intraoperative and Pos... | NCT02527226

Studies
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

NCT02527226

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Sep 16, 2016Estimated

Enrollment

76Actual

Phase

Not Applicable

Conditions

Parotid Neoplasms
Facial Paralysis

Interventions

Facial exercises

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Aug 17, 2015

First Submission Date that Met QC Criteria

Aug 17, 2015

First Posted Date

Aug 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2016

Last Update Posted Date

Sep 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Facial exercises	Behavioral	A series of self-administered facial movements and expressions.	Facial exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative facial weakness	Measure degree of facial weakness on postop day 1	postoperative day 1

Secondary Outcomes

Measure	Description	Time Frame
Time to resolution of facial weakness	Monitor time to resolution of weakness in the facial exercises and control groups	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Moore, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States
Mayo Clinic in Rochester

Condition Browse Module

MeSH Terms

ID	Term
D010307	Parotid Neoplasms
D005158	Facial Paralysis

Ancestor Terms

ID	Term
D012468	Salivary Gland Neoplasms
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided