Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 14, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedMarch 17, 2021
March 1, 2021
2 years
March 14, 2021
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
EXPERIMENTALA 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.
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.
Eligibility Criteria
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
- Kafrelsheikh Universitylead
- Fayoum Universitycollaborator
Study Sites (1)
Reda F Ali
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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