Complications in Parotid Surgery

Facial Palsy Clinical Trial

Official title:

Complications in Parotid Surgery - a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486393
• Other study ID #: JR/Helsinki/ORL/
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: June 28, 2015
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Facial Palsy

Intervention

Procedure:
• Parotid surgery
Surgery of the parotid gland tumours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	facial palsy		post op 12 months	Yes