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

Completed

• Conditions: Adenoma, Pleomorphic; Facial Nerve Injuries
• Interventions: Other: Superficial Parotidectomy

• Registration Number: NCT04706052
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief 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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2020-08
• Status Verified: 2021-01
• Study Completion: 2021-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-09
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Superficial Parotidectomy Patient	Superficial Parotidectomy	All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy

Primary Outcome Measures

Name	Time	Method
incidence of temporary or permanent facial nerve injury	12 months	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.

Secondary Outcome Measures

Name	Time	Method
seroma	12 months	Rate of postoperative formation of seroma (non-infected collection) occurring after superficial parotidectomy will be calculated
Frey's syndrome	12 months	Frey's syndrome is the result of misdirected regeneration of parasympathetic fibres connecting with regenerating sympathetic nerve leading to facial sweating and flushing during times of eating food. Rate of occurrence of Frey's syndrome will be calculated to understand its incidence.
hematoma	12 months	Rate of postoperative incidence of hematoma/ clot formation at the operative site will be calculated
salivary fistula	12 months	Salivary fistula is abnormal communication between skin and remaining gland. Its rate of occurrence will be calculated during postoperative period after superficial parotidectomy.
disfigured scar	12 months	The number of participants developing cosmetically bad scar will be notified and data calculated.
wound infection	12 months	Rate of postoperative surgical site infection will be calculated

Trial Locations

Locations (1)

Fazila Hashmi; 🇵🇰 Jāmshoro, Sindh, Pakistan