Overview

This trial is active, not recruiting.

Condition lacrimal duct obstruction
Treatment dcr
Sponsor Kuopio University Hospital
Start date September 2004
End date December 2011
Trial size 80 participants
Trial identifier NCT00571129, 255104, KUH5551812

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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

Primary Outcomes

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

Secondary Outcomes

Measure
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Recovery After Endoscopic Dacryocystorhinostomy
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.