NCT04706052

Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor

Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor: an Experience From a Low Resource Country

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

In this single-centre, cross-sectional case series, the investigators aim to evaluate the incidence of facial nerve injury in patients undergoing superficial parotidectomy in the absence of nerve conductor. Data to be collected retrospectively from a prospectively maintained database of consecutive patients, at the Department of Surgery, Liaquat University of Medical and Health Sciences Jamshoro, Pakistan. The sample size was calculated as 101.

Detailed description

In this single-centre, cross-sectional case series, the investigators aim to evaluate the incidence of facial nerve injury in partcipants undergoing superficial parotidectomy in the absence of nerve conductor. The institutional Research Ethics Committee has approved the study. Data to be collected retrospectively from a prospectively maintained database, at the Department of Surgery, Liaquat University of Medical and Health Sciences Jamshoro, Pakistan. The data period to be over a period of nine years that is from 1st January 2012 till August 2020. The sample size was calculated using the WHO sample size calculator and taking disease prevalence as 7.1 with CI 95%, which turned out to be 101. All the patients with pleomorphic adenoma irrespective of age and gender were included. To control any chance of bias, one of the members of researchers as part of the team who operated upon these patients. The primary outcome was the incidence of temporary or permanent facial nerve injury, while secondary outcomes were wound infection, seroma, hematoma, Frey's syndrome, salivary fistula and disfigured scar. Temporary facial nerve injury was defined as a feature of facial nerve palsy with full recovery to regular activity within six months. Permanent facial nerve injury was defined as any facial nerve dysfunction lasting beyond six months of operation. The data was recorded on a predesigned Performa, and patients' confidentiality was maintained assigning codes to each case known only to researchers. The data was calculated using SPSS version 23. Values of mean and standard deviation were calculated for continuous variables, whereas frequencies were calculated for categorical data.

Conditions

• Facial Nerve Injuries
• Adenoma, Pleomorphic

Interventions

Type	Name	Description
OTHER	Superficial Parotidectomy	Classical procedure for pleomorphic adenoma of the parotid gland is superficial parotidectomy around the world. This study only observed the outcome with reference to facial nerve morbidity

Timeline

• Start date: 2012-01-01
• Primary completion: 2020-08-01
• Completion: 2021-01-01
• First posted: 2021-01-12
• Last updated: 2021-01-13

Locations

1 site across 1 country: Pakistan