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

Sponsor

Kafrelsheikh University (Other)

Overall Status

Completed

CT.gov ID

NCT04803032

Collaborator

Fayoum University (Other)

Enrollment

Location

Arm

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parotid Tumor Parotid Neoplasms Surgery Head and Neck Disorder	Procedure: Superficial parotidectomy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 28, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Superficial parotidectomy using trident landmark technique 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 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.

Arm

Intervention/Treatment

Experimental: Superficial parotidectomy using trident landmark technique

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

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.

Outcome Measures

Primary Outcome Measures

Number of cases with successful identification of the facial neve by trident landmark [60 min]
measuring the rate of success of the trident landmark method in identification of the facial nerve during superficial parotidectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

cancers
unfit patients for surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reda F Ali	Kafr Ash Shaykh	Kafr Al Sheikh	Egypt	33516

Sponsors and Collaborators

Kafrelsheikh University
Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reda F. Ali, Lecturer of general surgery, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT04803032

Other Study ID Numbers:

10011616171

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parotid Neoplasms

Study Results

No Results Posted as of Mar 17, 2021