UMIN-CTR Clinical Trial

Basic information
Public title	An Artificial Intelligence-Based Outcome Evaluation for Facial Nerve Grafting in Head and Neck and Skull Base Surgery
Acronym	An Artificial Intelligence-Based Outcome Evaluation for Facial Nerve Grafting in Head and Neck and Skull Base Surgery
Scientific Title	An Artificial Intelligence-Based Outcome Evaluation for Facial Nerve Grafting in Head and Neck and Skull Base Surgery
Scientific Title:Acronym	An Artificial Intelligence-Based Outcome Evaluation for Facial Nerve Grafting in Head and Neck and Skull Base Surgery
Region	Japan

Condition
Condition	Head and Neck and Skull Base Tumors
Classification by specialty	Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to apply an artificial intelligence (AI)-based facial asymmetry evaluation system to the assessment of end results for facial nerve grafting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Artificial intelligence-calculated oral displacement ratio
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	200 years-old >
Gender	Male and Female
Key inclusion criteria	All patients who underwent facial nerve repair by interposition nerve grafting at our institution between 2017 and 2019
Key exclusion criteria	Patients without follow-up data 12 months after surgery or later were excluded
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Takeaki Middle name Last name Hidaka
Organization	Tokyo Medical and Dental University
Division name	Department of Plastic and Reconstructive Surgery
Zip code	1138519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL	0358035923
Email	tahidaka1986@gmail.com

Public contact
Name of contact person	1st name Takeaki Middle name Last name Hidaka
Organization	Tokyo Medical and Dental University
Division name	Department of Plastic and Reconstructive Surgery
Zip code	1138519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL	0358035923
Homepage URL
Email	tahidaka1986@gmail.com

Sponsor
Institute	Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None of the authors received any financial or other support or had any financial or professional relationship that might pose a competing interest.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University Hospital, Clinical Research Center
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel	0358035923
Email	tiken.crc@tmd.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	17
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 01 Day
Date of IRB	2015 Year 08 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2022 Year 06 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Seventeen patients underwent facial nerve grafting and were followed-up for more than 1 year postoperatively. On average, oral movement was recovered at around postoperative month 6. Grater patient age was significant for poor end results of resting oral symmetry. Postoperative radiation therapy, preoperative deficit duration, preoperative oral asymmetry, and nerve graft length were not significant. No significant factor was identified regarding synkinesis.

Management information
Registered date	2022 Year 06 Month 27 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054903