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Analysis of factors related to endoscopic dacryocystorhinostomy success

Status Approved

First Submitted Date

2018/10/11
Registered Date

2018/11/16
Last Updated Date

2018/11/07

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003359
Unique Protocol ID	CNUH 2018-02-010
Public/Brief Title	A study to find factors associated with the success of endoscopic dacryocystorhinostomy.
Scientific Title	Analysis of factors related to endoscopic dacryocystorhinostomy success
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUH 2018-02-010
Approval Date	2018-02-28
Institutional Review Board Name	chungnam national university hospital institutional review board
Institutional Review Board Address	282, Munhwa-ro, Jung-gu, Daejeon
Institutional Review Board Telephone	042-280-8715
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sung Bok Lee
Title	Ph.D.
Telephone	+82-42-280-7600
Affiliation	Chungnam National University Hospital
Address	Department of Ophthalmology, Chungnam National University Hospital, #282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea
Contact Person for Public Queries
Name	Taeseen Kang
Title	Dr.
Telephone	+82-42-280-7600
Affiliation	Chungnam National University Hospital
Address	Department of Ophthalmology, Chungnam National University Hospital, #282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea
Contact Person for Updating Information
Name	Taeseen Kang
Title	Dr.
Telephone	+82-42-280-7600
Affiliation	Chungnam National University Hospital
Address	Department of Ophthalmology, Chungnam National University Hospital, #282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2018-03-12 Actual
Target Number of Participant	245
Primary Completion Date	2018-09-01 , Actual
Study Completion Date	2018-09-01 , Actual
Name of Study	Chungnam National University Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2018-03-12 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Chungnam National University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chungnam National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	In the present study, we retrospectively reviewed the medical records of patients who underwent endoscopic dacryocystorhinostomy. The purpose of this study is to reveal the relationships between surgical success after 6 months and factors such as preoperative variables or triamcinolone injection or middle turbinectomy.

Study Summary Information

Lay Summary

In the present study, we retrospectively reviewed the medical records of patients who underwent endoscopic dacryocystorhinostomy. The purpose of this study is to reveal the relationships between surgical success after 6 months and factors such as preoperative variables or triamcinolone injection or middle turbinectomy.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Retrospective
Target Number of Participant	245
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Patients underwent endoscopic dacryocystorhinostomy
Cohort/ Group 1	Cohort/Group Description Subjective symptom(epiphora) Objective physical examination(nasal endoscope, lacrimal irrigation)
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	The patient who visited in Chungnam National University Hospital due to epiphora and underwent an endoscopic dacryocystorhinostomy.
Sampling Method	Selection by non-probabilistic extraction
Condition(s)/Problem(s)	* (H00-H59)Diseases of the eye and adnexa (H04.54)Acquired stenosis of nasolacrimal duct
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description - No distinction between men and women - Diagnosed with primary acquired nasolacrimal duct obstruction and underwent endoscopic dacryocystorhinostomy
Exclusion Criteria	- Patients who were not injected triamcinolone into either nasal cavity - Patients who had the history of failed endoscopic dacryocystorhinostomy. - Patients who did not undergo follow-up for 6 months after surgery
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	subjective epiphora
Timepoint	at 6 month
Primary Outcome(s) 2
Outcome	lacrimal irrigation
Timepoint	at 6 month
Secondary Outcome(s) 1
Outcome	granulation
Timepoint	at 3 month
Secondary Outcome(s) 2
Outcome	Synechiae
Timepoint	at 3 month
Secondary Outcome(s) 3
Outcome	recurrent
Timepoint	at 6 month

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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