Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy

Surgery Clinical Trial

Official title:

Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803032
• Other study ID #: 10011616171
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2021
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A prospective study was conducted between January 2018 and January 2020 at Kafr El-Sheikh university hospital (KUH) and Al Fayoum University Hospital (FUH), Egypt, on 60 patients with benign parotid tumors in the superficial lobe. All patients were subjected to superficial parotidectomy. The outcome was evaluated regarding the clinical success of facial nerve identification by trident landmark and early postoperative complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2020
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• cancers

• unfit patients for surgery

Related Conditions & MeSH terms

• Head and Neck Disorder
• Parotid Neoplasms
• Parotid Tumor
• Surgery

Intervention

Procedure:
• Superficial parotidectomy
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.

Locations

Country	Name	City	State
Egypt	Reda F Ali	Kafr Ash Shaykh	Kafr Al Sheikh

Sponsors (2)

Lead Sponsor	Collaborator
Kafrelsheikh University	Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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