Endoscopic Dacryocystorhinostomy Prospective Research

Not Applicable

• Conditions: Lacrimal Duct Obstruction
• Interventions: Procedure: DCR with no tubes or mitomycin

• Registration Number: NCT00571129
• Lead Sponsor: Kuopio University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Primary Completion: 2011-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without tubes or mitomycin	DCR with no tubes or mitomycin	After DCR no tubes were inserted After re-DCR no mitomycin was used
with tubes or mitomycin	DCR with no tubes or mitomycin	After DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes

Primary Outcome Measures

Name	Time	Method
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.	5 years

Secondary Outcome Measures

Name	Time	Method
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.	5 years

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, North-Savo, Finland