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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

December 10, 2007
January 9, 2013
September 2004
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00571129 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Endoscopic Dacryocystorhinostomy Prospective Research
Recovery After Endoscopic Dacryocystorhinostomy

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lacrimal Duct Obstruction
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
surgical
Intervention: Procedure: DCR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2013
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00571129
KUH5551812, 255104
No
Juha Seppa, Kuopio University Hospital
Kuopio University Hospital
Not Provided
Study Chair: Juha Seppä, MD,PhD Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland
Kuopio University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP