UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052649 |
|---|---|
| Receipt number | R000060081 |
| Scientific Title | Artificial Intelligence-Based Aesthetic Outcome Evaluation for Mandibular Reconstruction - Comparison among Vascularized Bone Grafts, Mandibular Reconstruction Plates and Soft Tissue Flaps |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2023/10/30 13:48:04 |
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Basic information
Public title
Artificial Intelligence-Based Aesthetic Outcome Evaluation for Mandibular Reconstruction - Comparison among Vascularized Bone Grafts, Mandibular Reconstruction Plates and Soft Tissue Flaps
Acronym
Artificial Intelligence-Based Aesthetic Outcome Evaluation for Mandibular Reconstruction - Comparison among Vascularized Bone Grafts, Mandibular Reconstruction Plates and Soft Tissue Flaps
Scientific Title
Artificial Intelligence-Based Aesthetic Outcome Evaluation for Mandibular Reconstruction - Comparison among Vascularized Bone Grafts, Mandibular Reconstruction Plates and Soft Tissue Flaps
Scientific Title:Acronym
Artificial Intelligence-Based Aesthetic Outcome Evaluation for Mandibular Reconstruction - Comparison among Vascularized Bone Grafts, Mandibular Reconstruction Plates and Soft Tissue Flaps
Region
| Japan |
Condition
Condition
Head and neck cancers
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 aesthetic outcome evaluation system to compare mandibular reconstruction plate and soft-tissue flap to vascularized bone graft.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mandibular asymmetry value was calculated for each patient's photograph using a facial recognition AI.
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
The study included all patients who underwent immediate reconstruction after segmental mandibulectomy from January 2015 to December 2022.
Key exclusion criteria
Patients without follow-up photographs 6 months or later after surgery were excluded.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
+81-4-7133-1111
tahidaka1986@gmail.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
+81-4-7133-1111
Homepage URL
tahidaka1986@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
None.
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Tel
+81-4-7133-1111
tahidaka1986@gmail.com
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
| 2023 | Year | 10 | Month | 30 | 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
65
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
| 2023 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively evaluated eligible patients who were divided into VBG, MRP and STF groups. Mandibular asymmetry value was calculated for each patient's photograph using a facial recognition AI, and was compared among the three groups. Complication rates and functional outcomes were also compared.
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060081
