UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042255 |
|---|---|
| Receipt number | R000048248 |
| Scientific Title | Change in Eyelid Closure Ratio after Static Reconstruction Surgery for Long-standing Facial Paralysis |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2020/10/27 16:47:16 |
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Basic information
Public title
Change in Eyelid Closure Ratio after Static Reconstruction Surgery for Long-standing Facial Paralysis
Acronym
Change in Eyelid Closure Ratio after Static Reconstruction Surgery for Long-standing Facial Paralysis
Scientific Title
Change in Eyelid Closure Ratio after Static Reconstruction Surgery for Long-standing Facial Paralysis
Scientific Title:Acronym
Change in Eyelid Closure Ratio after Static Reconstruction Surgery for Long-standing Facial Paralysis
Region
| Japan |
Condition
Condition
Facial paralysis
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study was to analyze the change in the degree of eyelid closure in spontaneous blink after static eyelid reconstruction surgery to elucidate risk factors associated with postoperative deterioration of eyelid closure function.
Basic objectives2
Others
Basic objectives -Others
The primary aim of this study was to analyze the change in the degree of eyelid closure in spontaneous blink after static eyelid reconstruction surgery to elucidate risk factors associated with postoperative deterioration of eyelid closure function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in postoperative (1-12 months) eyelid closure ratio compared to preoperative eyelid closure 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We included patients with unilateral facial paralysis who underwent their first static eyelid reconstruction surgery at our specialist clinic for facial paralysis in the eligibility period from October 2017 to September 2020.
Key exclusion criteria
Exclusion criteria included prior history of static eyelid reconstruction surgery, bilateral paralysis, and congenital paralysis.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | Hidaka |
| Last name | Hidaka |
Organization
The University of Tokyo Hospital
Division name
Plastic, Reconstructive and Aesthetic Surgery
Zip code
1138655
Address
Hongo
TEL
+819061377950
tahidaka1986@gmail.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | Hidaka |
| Last name | Hidaka |
Organization
The University of Tokyo
Division name
Plastic, Reconstructive and Aesthetic Surgery
Zip code
1138655
Address
Hongo
TEL
+819061377950
Homepage URL
https://www.h.u-tokyo.ac.jp/plastic/
tahidaka1986@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Plastic, Reconstructive and Aesthetic Surgery, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
+813-5841-0818
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
| 2020 | Year | 10 | 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
66
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 | 08 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The closure ratio was evaluated at six perioperative time points for each patient: preoperative, postoperative (PO) 1, 3, 6, 9, and 12 months (M).
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048248
