A Study of Post-parotidectomy Facial Paresis Intraoperative and Postoperative Factors
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-004441
- Rochester, Minnesota: 15-004441
NCT ID: NCT02527226
Sponsor Protocol Number: 15-004441
About this study
This is a prospective trial of facial nerve monitoring in patients undergoing parotidectomy to see if the facial nerve monitor provides useful information to operating surgeons and if the information provided 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Eric Moore, M.D. |
Closed for enrollment |
|
Rochester, Minn.
Mayo Clinic principal investigator Eric Moore, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available