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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043284
Receipt No. R000047951
Scientific Title Evaluation of surgical outcome after endoscopic dacryocystorhinostomy
Date of disclosure of the study information 2021/05/01
Last modified on 2021/02/09

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Basic information
Public title Evaluation of surgical outcome after endoscopic dacryocystorhinostomy
Acronym Surgical outcome of endoscopic DCR
Scientific Title Evaluation of surgical outcome after endoscopic dacryocystorhinostomy
Scientific Title:Acronym Surgical outcome of endoscopic DCR
Region
Japan

Condition
Condition nasolacrimal duct obstruction,dacryocystitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate outcomes and prognostic factors of endoscopic DCR perfomed at Japanese Red Cross Osaka Hosopital and Hyogo Prefectural Amagasaki General Medical Center.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Anatomic patency based on lacrimal irrigation before surgery, 7 weeks after surgery, and 52 weeks after surgery.
Key secondary outcomes 1.Assessment of change in tear meniscus height measured by anterior segment optical coherence tomography.
2.Quantitative assessment of improvement in subjective symptoms scored by tree-grade evaluation as follows: (1)complete resolution,(2)moderate epiphora,(3)no improvement
These evaluations were performed before surgery, 7 weeks after surgery, and 52 weeks after surgery.

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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1.The cases of nasolacrimal duct obstruction,acute and chronic dacryocystitis.
2.The case that have never undergone prior external and/or endoscopic DCR.
Key exclusion criteria 1.The case in which the part of obstruction is proximal to common canaliculus.
2.The case undergone endoscopic sinus surgery at the same time of endoscopic DCR.
3.The case of which consent can't be obtained from the patients.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hiroko
Middle name
Last name Matsuyama
Organization Japanese Red Cross Osaka Hosopital
Division name Ophthalmology
Zip code 543-8555
Address 5-30 Fudegasakicho, Tennoji-ku,Osaka
TEL 0667745111
Email hospital@osaka-med.jrc.or.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Matsuyama
Organization Japanese Red Cross Osaka Hosopital
Division name Ophthalmology
Zip code 543-8555
Address 5-30 Fudegasakicho, Tennoji-ku,Osaka
TEL 0667745111
Homepage URL https://www.osaka-med.jrc.or.jp/aboutus/information/ethics.html
Email hospital@osaka-med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Osaka Hosopital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyougo Prefectural Amagasaki General Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese Red Cross Osaka Hosopital
Address 5-30 Fudegasakicho, Tennoji-ku,Osaka
Tel 0667745111
Email hospital@osaka-med.jrc.or.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 大阪赤十字病院、兵庫県立尼崎総合医療センター

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 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
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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2020 Year 09 Month 04 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2022 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 02 Month 09 Day
Last modified on
2021 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047951

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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