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Endoscopic Dacryocystorhinostomy Prospective Research
This study is ongoing, but not recruiting participants.
Sponsor:
Kuopio University Hospital
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00571129
First received: December 10, 2007
Last updated: March 10, 2016
Last verified: March 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Lacrimal Duct Obstruction | Procedure: DCR |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Recovery After Endoscopic Dacryocystorhinostomy |
Resource links provided by NLM:
Further study details as provided by Juha Seppa, Kuopio University Hospital:
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. [ Time Frame: 5 years ]
Secondary Outcome Measures:
- The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation. [ Time Frame: 5 years ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| surgical |
Procedure: DCR
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00571129
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571129
Locations
| Finland | |
| Kuopio University Hospital | |
| Kuopio, North-Savo, Finland, 70210 | |
Sponsors and Collaborators
Kuopio University Hospital
Investigators
| Study Chair: | Juha Seppä, MD,PhD | Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland |
More Information
Publications:
| Responsible Party: | Juha Seppa, PhD, Kuopio University Hospital |
| ClinicalTrials.gov Identifier: | NCT00571129 History of Changes |
| Other Study ID Numbers: |
KUH5551812 255104 |
| Study First Received: | December 10, 2007 |
| Last Updated: | March 10, 2016 |
Keywords provided by Juha Seppa, Kuopio University Hospital:
|
Primary,silicone tube,revision,mitomycin C,endoscopic DCR |
Additional relevant MeSH terms:
|
Lacrimal Duct Obstruction Lacrimal Apparatus Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 20, 2017