Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Superficial Parotidectomy Patient All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy |
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
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Outcome Measures
Primary Outcome Measures
- 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
- wound infection [12 months]
Rate of postoperative surgical site infection will be calculated
- seroma [12 months]
Rate of postoperative formation of seroma (non-infected collection) occurring after superficial parotidectomy will be calculated
- hematoma [12 months]
Rate of postoperative incidence of hematoma/ clot formation at the operative site 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.
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fazila Hashmi | Jāmshoro | Sindh | Pakistan |
Sponsors and Collaborators
- Liaquat University of Medical & Health Sciences
Investigators
- Principal Investigator: Fazila Hashmi, FCPS, Liaquat University of Medical and Health Sciences Jamshoro Pakistan
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Gaillard C, Périé S, Susini B, St Guily JL. Facial nerve dysfunction after parotidectomy: the role of local factors. Laryngoscope. 2005 Feb;115(2):287-91.
- 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.
- 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.
- LUMHS/REC/-12