UMIN-CTR Clinical Trial

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
Email	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/
Email	tahidaka1986@gmail.com

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048248