NCT04706052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

8.6 years

First QC Date

January 9, 2021

Last Update Submit

January 11, 2021

Conditions

Facial Nerve InjuriesAdenoma, Pleomorphic

Keywords

Superficial ParotidectomyFacial Nerve InjuriesAdenoma, Pleomorphic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • wound infection

    12 months

  • seroma

    12 months

  • hematoma

    12 months

  • Frey's syndrome

    12 months

  • salivary fistula

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Superficial Parotidectomy Patient

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

Other: Superficial Parotidectomy

Interventions

Superficial ParotidectomyOTHER

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

Superficial Parotidectomy Patient

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All the patients with pleomorphic adenoma irrespective of age and gender were included

You may not qualify if:

  • Patients with recurrent disease or unwilling for participation were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fazila Hashmi

Jāmshoro, Sindh, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 32063945BACKGROUND

  • 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.

    PMID: 26777078BACKGROUND

  • 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.

    PMID: 32864440BACKGROUND

  • 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.

    PMID: 24605304BACKGROUND

  • 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.

    PMID: 15689752BACKGROUND

MeSH Terms

Conditions

Facial Nerve InjuriesAdenoma, Pleomorphic

Condition Hierarchy (Ancestors)

Facial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsAdenomaNeoplasms, Glandular and Epithelial

Study Officials

  • Fazila Hashmi, FCPS

    Liaquat University of Medical and Health Sciences Jamshoro Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 9, 2021

First Posted

January 12, 2021

Study Start

January 1, 2012

Primary Completion

August 1, 2020

Study Completion

January 1, 2021

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

PA(1)