UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043284 |
|---|---|
| Receipt number | 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 12:27:12 |
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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
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
hospital@osaka-med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Osaka Hosopital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047951
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
