Comparison of the incidence of facial nerve dysfunction in patients submitted to surgery for parotid gland tumors with or without facial nerve monitoring with continuous electromyographic register during the surgery
| ISRCTN | ISRCTN13966417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13966417 |
| Secondary identifying numbers | CAAE: 27574914.4.2094.5404 |
- Submission date
- 04/02/2018
- Registration date
- 01/03/2018
- Last edited
- 12/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Faculty of Medical Sciences
State University of Campinas
Rua Tessália Vieira de Camargo 126
Cidade Universitária
Campinas
13083-887
Brazil
 ORCID ID |
0000-0003-4643-929X |
|---|---|
| Phone | +55 47 3422 8262 |
| agnaldograciano@gmail.com |
Study information
| Study design | Two center prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Facial Nerve Monitoring during superficial parotidectomy for benign tumors of the parotid gland: a prospective randomized trial |
| Study objectives | Facial nerve monitoring may reduce the incidence of facial nerve dysfunction and/or it's degree following superficial parotidectomy |
| Ethics approval(s) | Ethical Committee of the Faculty of Medical Sciences State University of Campinas, 09/04/2015, ref: 1008.206 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/01/2015 |
| Completion date | 15/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 124 |
| Key inclusion criteria | 1. Adult 2. Aged 18 to 85 years 3. Benign parotid tumor(s) 4. Normal neuromuscular facial function prior to surgery |
| Key exclusion criteria | 1. Malignant parotid tumor(s) |
| Date of first enrolment | 15/04/2015 |
| Date of final enrolment | 15/06/2018 |
Locations
Countries of recruitment
- Brazil
Study participating centres
13083-888
Brazil
89202-000
Brazil
Sponsor information
University/education
Rua Tessália Vieira de Camargo
126 - Cidade Universitária Zeferino Vaz.
Campinas
13083-887
Brazil
"ROR" |
https://ror.org/04wffgt70 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish the results of this trial in a peer reviewed medical periodical. |
| IPD sharing plan | 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. Additional and raw data can be accessed at: http://repositorio.unicamp.br/handle/REPOSIP/332793 (added 12/12/2019) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2018 | Yes | No |
Editorial Notes
12/12/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. A link to access the raw data was added to the publication and dissemination plan.
