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Endoscopic Dacryocystorhinostomy Prospective Research

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571129
First Posted: December 11, 2007
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital
  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 2017
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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

Publications:
Responsible Party: Juha Seppa, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00571129     History of Changes
Other Study ID Numbers: KUH5551812
255104
First Submitted: December 10, 2007
First Posted: December 11, 2007
Last Update Posted: November 15, 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