Complications in Parotid Surgery

Complications in Parotid Surgery - a Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Facial Palsy
• Intervention / Treatment: Procedure: Parotid surgery

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 Type: Observational
• Enrollment (Actual): 178

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• parotid gland tumour surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
type of surgery; patients undergoing parotid surgery	Procedure: Parotid surgery; Surgery of the parotid gland tumours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
facial palsy	post op 12 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 28, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 28, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; Paralysis; Facial Paralysis
• Other Study ID Numbers: JR/Helsinki/ORL/