UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048179 |
|---|---|
| Receipt number | R000054903 |
| Scientific Title | An Artificial Intelligence-Based Outcome Evaluation for Facial Nerve Grafting in Head and Neck and Skull Base Surgery |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2022/06/27 17:59:14 |
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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
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
tahidaka1986@gmail.com
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
