Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis

December 28, 2016 updated by: Tijn van Veen, University Medical Center Groningen

A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years.

  • Imagery analysis
  • Questionnaires

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective cohort of people treated with a cross-face nerve graft or other nerve transfer

Description

Inclusion Criteria:

  • Treated with one of the described procedures

Exclusion Criteria:

  • Evaluation material present

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cross-face nerve graft treated
People treated by a solitary cross-face nerve graft or in combination with another procedure.
Procedure: Cross-face nerve graft
connecting the healthy facial nerve to the affected facial nerve
Hypoglossal-facial treated
People treated with a solitary hypoglossal-facial anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symmetry of the mouth
Time Frame: March 2016 - October 2016
Symmetry of the mouth expressed as the difference in millimeters between the position of the affected and the healthy corner of the mouth on a picture. An ideal symmetry would be 0 mm. Measured with the FACE-gram software.
March 2016 - October 2016
Excursion of the mouth
Time Frame: March 2016 - October 2016
Excursion of the mouth expressed as the difference in millimeters between the position of the affected corner of the mouth in repose and with smile on a picture. Measured with the FACE-gram software.
March 2016 - October 2016
Disease-specific quality-of-life
Time Frame: March 2016 - October 2016
A validated self-reported disease-specific quality-of-life questionnaire was used (Facial Clinimetric Evaluation scale). On which patients can score anything between 0 and 100 points (100 being healty).
March 2016 - October 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (ESTIMATE)

December 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TvanVeen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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