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

NCT ID: NCT04706052

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2021-01-31

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.

Conditions

Facial Nerve Injuries; Adenoma, Pleomorphic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Superficial Parotidectomy Patient

All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy

Superficial Parotidectomy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Fazila Hashmi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fazila Hashmi, FCPS

Role: PRINCIPAL_INVESTIGATOR

Liaquat University of Medical and Health Sciences Jamshoro Pakistan

Locations

Fazila Hashmi

Jāmshoro, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 32063945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26777078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32864440 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24605304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15689752 (View on PubMed)

Other Identifiers

LUMHS/REC/-12

Identifier Type: -

Identifier Source: org_study_id