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Endoscopic Dacryocystorhinostomy Prospective Research

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00571129
First received: December 10, 2007
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Recovery After Endoscopic Dacryocystorhinostomy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: September 2004
Estimated Study Completion Date: December 2013
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
Genders Eligible for Study:   Both
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
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

No publications provided

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: January 9, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by 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 May 22, 2013