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Sponsored by: |
Kuopio University Hospital |
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Information provided by: | Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT00571129 |
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 |
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Lacrimal Duct Obstruction |
Procedure: DCR |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Recovery After Endoscopic Dacryocystorhinostomy |
Estimated Enrollment: | 80 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
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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 |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland, North-Savo | |
Kuopio University Hospital | |
Kuopio, North-Savo, Finland, 70210 |
Study Chair: | Juha Seppä, MD,PhD | Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland |
Responsible Party: | Kuopio University Hospital ( Grigori Smirnov ) |
Study ID Numbers: | KUH5551812, 255104 |
Study First Received: | December 10, 2007 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00571129 |
Health Authority: | Finland: Ethics Committee |
Primary,silicone tube,revision,mitomycin C,endoscopic DCR |
Eye Diseases Mitomycin Lacrimal Apparatus Diseases Mitomycins Lacrimal Duct Obstruction |