Clinical trial NCT04706052: Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor
Official title: Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor: an Experience From a Low Resource Country
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Nerve Injuries
Adenoma, Pleomorphic
Keywords: Superficial Parotidectomy
Facial Nerve Injuries
Adenoma, Pleomorphic
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the suitable and selected patients consented for surgery with an explanation of procedure-related complications. Superficial parotidectomy was a standard surgical procedure for these selected patients with previously untreated pleomorphic adenoma.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of temporary or permanent facial nerve injury
timeFrame: 12 months
Secondary outcomes:
measure: wound infection
timeFrame: 12 months
measure: seroma
timeFrame: 12 months
measure: hematoma
timeFrame: 12 months
measure: Frey's syndrome
timeFrame: 12 months
measure: salivary fistula
timeFrame: 12 months
measure: disfigured scar
timeFrame: 12 months
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Fazila Hashmi
state: Sindh
Study officials:
affiliation: Liaquat University of Medical and Health Sciences Jamshoro Pakistan
name: Fazila Hashmi, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siddiqui AH, Shakil S, Rahim DU, Shaikh IA. Post parotidectomy facial nerve palsy: A retrospective analysis. Pak J Med Sci. 2020 Jan-Feb;36(2):126-130. doi: 10.12669/pjms.36.2.1706.
citation: Bittar RF, Ferraro HP, Ribas MH, Lehn CN. Facial paralysis after superficial parotidectomy: analysis of possible predictors of this complication. Braz J Otorhinolaryngol. 2016 Jul-Aug;82(4):447-51. doi: 10.1016/j.bjorl.2015.08.024. Epub 2015 Dec 19.
citation: Al-Qahtani KH, AlQahtani FM, Muqat MM, AlQahtani MS, Al-Qannass AM, Islam T, Alharbi J, Sebaih H, Alqarni M, Hakami H. A new landmark for the identification of the facial nerve during parotid surgery: A cadaver study. Laryngoscope Investig Otolaryngol. 2020 Jul 28;5(4):689-693. doi: 10.1002/lio2.431. eCollection 2020 Aug.
citation: Saha S, Pal S, Sengupta M, Chowdhury K, Saha VP, Mondal L. Identification of facial nerve during parotidectomy: a combined anatomical & surgical study. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(1):63-8. doi: 10.1007/s12070-013-0669-z. Epub 2013 Jul 24.
citation: Gaillard C, Perie S, Susini B, St Guily JL. Facial nerve dysfunction after parotidectomy: the role of local factors. Laryngoscope. 2005 Feb;115(2):287-91. doi: 10.1097/01.mlg.0000154735.61775.cd.