Parotid NeoplasmsNCT02527226
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
A study testing Facial exercises in people with Parotid Neoplasms and Facial Paralysis, run by Mayo Clinic at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Neoplasms, Facial Paralysis
- What is being tested?
- Facial exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Planned parotid gland surgery (superficial or total parotidectomy)
- Benign or malignant disease
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
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.
- Conditions
- Parotid Neoplasms, Facial Paralysis
- Being tested
- Facial exercises
- Medical subject headings
- Parotid Neoplasms, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial exercisesBehavioural
A series of self-administered facial movements and expressions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Facial exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative facial weakness
Measure degree of facial weakness on postop day 1
Measured: postoperative day 1
Secondary outcomes (1)
Time to resolution of facial weakness
Monitor time to resolution of weakness in the facial exercises and control groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric J. Moore, M.D., Mayo Clinic
- Investigators
- Eric Moore, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527226
- Sponsor's protocol ID
- 15-004441
- Status last verified
- Sep 2016
- First submitted
- 17 Aug 2015
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
- ClinicalTrials.gov ID
- NCT02527226
- Acronym / sponsor ID
- 15-004441
- Conditions
- Parotid Neoplasms, Facial Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No facial exercises | No intervention | –This group will not receive any training in facial exercises. |
| Facial exercises | Experimental | Behavioral: Facial exercisesThis group will receive instruction to perform a series of self-administered exercises of facial expression and movements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Planned parotid gland surgery (superficial or total parotidectomy)
- Benign or malignant disease
Key exclusion criteria (8 listed)
- Pregnancy
- Preoperative facial nerve dysfunction
- Revision operation
- History of preoperative radiation to the surgical field
- Entire nerve not dissected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial exercisesA series of self-administered facial movements and expressions. | Behavioural | Facial exercises |
Primary outcome
Postoperative facial weakness
Time frame: postoperative day 1
Measure degree of facial weakness on postop day 1
1 secondary outcome
Time to resolution of facial weakness
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Moore, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial exercises in people with Parotid Neoplasms and Facial Paralysis, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative facial weakness (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.