Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-31 @ 8:28 PM
Study NCT ID:
NCT02486393
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications in Parotid Surgery
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
Complications in Parotid Surgery - a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. Their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. Also other complications occurring within 12 months of operation were recorded.
Detailed Description:
Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled. Exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: