NCT04803032

Brief Summary

The parotid has a close relationship with the extra temporal course of the facial nerve. The study aimed to evaluate the accuracy and safety of trident landmark during superficial parotidectomy in the identification of the facial nerve trunk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 14, 2021

Last Update Submit

March 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of cases with successful identification of the facial neve by trident landmark

    measuring the rate of success of the trident landmark method in identification of the facial nerve during superficial parotidectomy

    60 min

Study Arms (1)

Superficial parotidectomy using trident landmark technique

EXPERIMENTAL

A modified Blair incision was made along the preauricular skin crease with the same steps of the routine parotid surgery. Dissection was performed using bipolar cautery and blunt instrument; from the tragal cartilage (the anterior surface) until the bony anterior wall of the external auditory canal (EAC); from there, the dissection was done using a blunt instrument. The styloid process's base is the upper point of the trident landmark; it is the superior portion of the trident landmark. Identification of the posterior belly of the digastric muscle till its origin was performed deep to the sternocleidomastoid muscle; it is the lower point of the landmark. The facial nerve is located in the region between these two structures.

Procedure: Superficial parotidectomy

Interventions

The parotid gland was exposed with its capsule by subplatysmal and SMAS flaps. Dissection was performed from the tragal cartilage until the bony anterior wall of the external auditory canal; from there, the dissection was done using a blunt instrument. The styloid process's base is the upper point of the trident landmark; it is the superior portion of the trident landmark. Identification of the posterior belly of the digastric muscle till its origin was performed deep to the sternocleidomastoid muscle. ); it is the lower point of the landmark. The FNT is located in the region between these two structures. The dissection after identification of the main trunk of the facial nerve was similar to the routine parotidectomy. The surgical defect was closed over a removac suction drain using Vicryl materials; the skin was closed by 6-0 absorbable sutures. A dressing was applied to the surgical site. Then, a gauze was wrapped over the parotid area and secured around the forehead and neck.

Superficial parotidectomy using trident landmark technique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with benign tumors of the superficial lobe of the parotid gland

You may not qualify if:

  • cancers
  • unfit patients for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reda F Ali

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland NeoplasmsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesParotid DiseasesSalivary Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

January 1, 2018

Primary Completion

December 28, 2019

Study Completion

January 1, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations