Condition category
Surgery
Date applied
04/02/2018
Date assigned
01/03/2018
Last edited
14/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The parotid gland is situated in the mouth and makes saliva. Lumps can occur in this gland due to abnormal growth, and are called parotid gland tumours. They can be removed by surgery called superficial parotidectomy. Temporary facial nerve weakness (dysfunction) is the most common complication following this surgery, caused by damage to an important nerve that passes through the parotid gland, called the facial nerve.
A series of techniques called continuous intraoperative electromyography can be used to monitor the electrical activity of the facial nerve in an attempt to reduce the incidence of this complication.
The objective of this study is to prospectively evaluate adult patients with benign parotid tumors that will be treated with superficial parotidectomy with or without facial nerve monitoring, and compare the rates and degree of immediate facial nerve dysfunction between these groups and evaluate specific patient outcome results related to these facial disabilities.
This study aims to see if facial nerve monitoring reduces the rate and degree of facial nerve dysfunction following facial surgery to remove parotid tumours.

Who can participate?
Adults aged 18 to 85 years with benign parotid tumours

What does the study involve?
Participants are randomly allocated to the intervention group or control group.
Those in the intervention group undergo superficial parotidectomy with continuous facial nerve monitoring using intraoperative electromyography. Those in the control group have the surgery with standard visual facial nerve monitoring.
Participants have their facial movements filmed prior to surgery and at 7, 30, 90 and 180 days after the procedure.

What are the possible benefits and risks of participating?
Participants may benefit from the reduced risk of face paralysis during surgery and also help others benefit from this in the future if monitoring is shown to be successful.
There are no additional risks for participants, other than those already related to this type of surgery, such as pain and discomfort in the operated area, temporary or permanent facial paralysis and facial hematoma (bleeding under the skin of the face).

Where is the study run from?
1. Hospital das Clínicas da Universidade Estadual de Campinas (Brazil)
2. Hospital São José Joinville (Brazil)

When is the study starting and how long is it expected to run for?
April 2015 to June 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Agnaldo Jose Graciano (Scientific)
agnaldograciano@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Agnaldo Graciano

ORCID ID

http://orcid.org/0000-0003-4643-929X

Contact details

Faculty of Medical Sciences
State University of Campinas
Rua Tessália Vieira de Camargo 126
Cidade Universitária
Campinas
13083-887
Brazil
+55 47 3422 8262
agnaldograciano@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAAE: 27574914.4.2094.5404

Study information

Scientific title

Facial Nerve Monitoring during superficial parotidectomy for benign tumors of the parotid gland: a prospective randomized trial

Acronym

Study hypothesis

Facial nerve monitoring may reduce the incidence of facial nerve dysfunction and/or it's degree following superficial parotidectomy

Ethics approval

Ethical Committee of the Faculty of Medical Sciences State University of Campinas, 09/04/2015, ref: 1008.206

Study design

Two center prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Facial nerve dysfunction following superficial parotidectomy

Intervention

Participants with benign tumours of the parotid gland undergoing superficial parotidectomy are randomly assigned to the intervention (facial nerve monitoring) or control group on the day of surgery, using a randomized list created by random allocation software.
The intervention group undergo surgery with facial nerve monitoring using continuous intraoperative electromyography, which registers any stimulus that could indicate an irritation of the facial nerve.
The control group undergo standard surgery with continuous visual monitoring of the facial nerve, but no additional information from the electromyographic register.
Post operative facial nerve movement will be recorded using a HD camera and graded by experienced physicians at 30, 90 and 180 days after the surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Incidence of facial nerve dysfunction measured by experienced physicians up to 30 days (immediate) and 180 days (late) following superficial parotidectomy

Secondary outcome measures

Degree of facial nerve dysfunction evaluated by experienced physicians at 30, 90 and 180 days following surgery

Overall trial start date

15/01/2015

Overall trial end date

15/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult
2. Aged 18 to 85 years
3. Benign parotid tumor(s)
4. Normal neuromuscular facial function prior to surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Malignant parotid tumor(s)

Recruitment start date

15/04/2015

Recruitment end date

15/06/2018

Locations

Countries of recruitment

Brazil

Trial participating centre

Hospital das Clínicas da Universidade Estadual de Campinas
Campinas
13083-888
Brazil

Trial participating centre

Hospital São José Joinville
Joinville
89202-000
Brazil

Sponsor information

Organisation

Faculty of Medical Sciences - UNICAMP

Sponsor details

Rua Tessália Vieira de Camargo
126 - Cidade Universitária Zeferino Vaz.
Campinas
13083-887
Brazil

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the results of this trial in a peer reviewed medical periodical.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Agnaldo Graciano at agnaldograciano@gmail.com. Individual participant data that underlie the results reported in this article, including text, tables, figures, appendices and study protocol will be available for researchers that provide a proposal for individual participant data meta-analysis. Beginning 3 months ending 3 years after publication.

Intention to publish date

15/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes