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Endoscopic Dacryocystorhinostomy Prospective Research

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ClinicalTrials.gov Identifier: NCT00571129
Recruitment Status : Active, not recruiting
First Posted : December 11, 2007
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lacrimal Duct Obstruction Procedure: DCR Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recovery After Endoscopic Dacryocystorhinostomy
Study Start Date : September 2004
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation. [ Time Frame: 5 years ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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 (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Juha Seppa, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00571129     History of Changes
Other Study ID Numbers: KUH5551812
255104
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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