Endoscopic Dacryocystorhinostomy Prospective Research

Study Overview
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Brief Summary
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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.

Official Title
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Recovery After Endoscopic Dacryocystorhinostomy

Conditions
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Lacrimal Duct Obstruction

Intervention / Treatment
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* Procedure: DCR with no tubes or mitomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: DCR with/ without tubes Revision DCR with/ without mitomycin
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with tubes or mitomycin<br>After DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes | Procedure: DCR with no tubes or mitomycin<br>* 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<br>* Other names: DCR with tubes or mitomycin;|
| Active Comparator: without tubes or mitomycin<br>After DCR no tubes were inserted After re-DCR no mitomycin was used | Procedure: DCR with no tubes or mitomycin<br>* 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<br>* Other names: DCR with tubes or mitomycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary,silicone tube,revision,mitomycin C,endoscopic DCR