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

L

Liaquat University of Medical & Health Sciences

Status

Completed

Conditions

Facial Nerve Injuries
Adenoma, Pleomorphic

Treatments

Other: Superficial Parotidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04706052
LUMHS/REC/-12

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All the patients with pleomorphic adenoma irrespective of age and gender were included

Exclusion criteria

  • Patients with recurrent disease or unwilling for participation were excluded

Trial design

101 participants in 1 patient group

Superficial Parotidectomy Patient
Description:
All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy
Treatment:
Other: Superficial Parotidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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