NCT02486393

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

June 25, 2015

Last Update Submit

June 28, 2015

Conditions

Facial Palsy

Outcome Measures

Primary Outcomes (1)

  • facial palsy

    post op 12 months

Study Arms (1)

type of surgery

patients undergoing parotid surgery

Procedure: Parotid surgery

Interventions

Parotid surgeryPROCEDURE

Surgery of the parotid gland tumours

type of surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • parotid gland tumour surgery

You may not qualify if:

  • age under 18
  • suspicion of malignancy or facial schwannoma
  • a tumor extending into the parapharyngeal space
  • previous parotid surgery exposing facial nerve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 1, 2015

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

July 1, 2015

Record last verified: 2015-06