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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Facial Nerve Injuries, Adenoma, Pleomorphic

Intervention / Treatment
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* Other: Superficial Parotidectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Superficial Parotidectomy Patient<br>All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy | Other: Superficial Parotidectomy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of temporary or permanent facial nerve injury | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection | Rate of postoperative surgical site infection will be calculated | 12 months | 
| seroma | Rate of postoperative formation of seroma (non-infected collection) occurring after superficial parotidectomy will be calculated | 12 months | 
| hematoma | Rate of postoperative incidence of hematoma/ clot formation at the operative site will be calculated | 12 months | 
| Frey's syndrome | 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. | 12 months | 
| salivary fistula | Salivary fistula is abnormal communication between skin and remaining gland. Its rate of occurrence will be calculated during postoperative period after superficial parotidectomy. | 12 months | 
| disfigured scar | The number of participants developing cosmetically bad scar will be notified and data calculated. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Parotidectomy, Facial Nerve Injuries, Adenoma, Pleomorphic