Endoscopic Dacryocystorhinostomy Prospective Research
Primary Purpose
Lacrimal Duct Obstruction
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
DCR with no tubes or mitomycin
Sponsored by
About this trial
This is an interventional treatment trial for Lacrimal Duct Obstruction focused on measuring Primary,silicone tube,revision,mitomycin C,endoscopic DCR
Eligibility Criteria
Inclusion Criteria:
- Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
- Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Exclusion Criteria:
- Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
with tubes or mitomycin
without tubes or mitomycin
Arm Description
After DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes
After DCR no tubes were inserted After re-DCR no mitomycin was used
Outcomes
Primary Outcome Measures
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
Secondary Outcome Measures
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.
Full Information
NCT ID
NCT00571129
First Posted
December 10, 2007
Last Updated
February 21, 2020
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00571129
Brief Title
Endoscopic Dacryocystorhinostomy Prospective Research
Official Title
Recovery After Endoscopic Dacryocystorhinostomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Duct Obstruction
Keywords
Primary,silicone tube,revision,mitomycin C,endoscopic DCR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
DCR with/ without tubes Revision DCR with/ without mitomycin
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with tubes or mitomycin
Arm Type
Active Comparator
Arm Description
After DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes
Arm Title
without tubes or mitomycin
Arm Type
Active Comparator
Arm Description
After DCR no tubes were inserted After re-DCR no mitomycin was used
Intervention Type
Procedure
Intervention Name(s)
DCR with no tubes or mitomycin
Other Intervention Name(s)
DCR with tubes or mitomycin
Intervention Description
The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR.
In revision group patients were randomized into the two groups,ether with or without application of mitomycin "C" after DCR
Primary Outcome Measure Information:
Title
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Exclusion Criteria:
Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Seppä, MD,PhD
Organizational Affiliation
Kuopio University Hospital, Otorhinolaryngology
Official's Role
Study Chair
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
North-Savo
ZIP/Postal Code
70210
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24851037
Citation
Penttila E, Hyttinen JM, Hytti M, Kauppinen A, Smirnov G, Tuomilehto H, Seppa J, Nuutinen J, Kaarniranta K. Upregulation of inflammatory genes in the nasal mucosa of patients undergoing endonasal dacryocystorhinostomy. Clin Ophthalmol. 2014 Apr 25;8:799-805. doi: 10.2147/OPTH.S50195. eCollection 2014.
Results Reference
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Endoscopic Dacryocystorhinostomy Prospective Research
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