Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Study Overview
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Brief Summary
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Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction. As a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. The most common cause of unsuccessful surgery is intranasal stoma scarring. One of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during DCR, so-called bicanalicular intubation of the lacrimal system. The aim of the study is to compare long term effectiveness of DCR with and without bicanalicular intubation.

Detailed Description
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Dacryocystorinostomy (DCR) is an operation that is indicated for lacrimal duct obstruction. Lacrimal duct obstruction can be caused by inflamation and trauma or might be the consequence of previous surgery in the lacrimal duct region. As a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. During DCR, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. The results of DCR are generally excellent and the success rate (regression of complaints) varies between 85-95% depending on the condition of the lacrimal pathways before surgery. Yet there is a constant effort to improve the results of operations. The most common cause of unsuccessful surgery is intranasal stoma scarring. It is caused by an inadequately formed bone window, an individual tendency to healing and scar formation, but a frequent cause is the insufficient opening of the tear bag or the formation of scars between the nasal septum and the lateral nasal wall. One of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during DCR, so-called bicanalicular intubation of the lacrimal system. Silicone stent remains in the lacrimal system for 12 weeks and prevents scarring. Results of previous studies are not clear whether bicanalicular intubation is beneficial. The aim of the study is to compare long term effectiveness of DCR with and without bicanalicular intubation.

Official Title
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Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Conditions
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Lacrimal Duct Obstruction

Intervention / Treatment
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* Procedure: dacryocystorinostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with lacrimal duct obstruction 18 to 79 years of age capable of general anesthesia signing of the informed consent Exclusion Criteria: - inability to undergo general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized into two parallel groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dacryocystorinostomy with bicanalicular intubation<br>Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation. | Procedure: dacryocystorinostomy<br>* Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.<br>|
| Experimental: Dacryocystorinostomy without bicanalicular intubation<br>Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation. | Procedure: dacryocystorinostomy<br>* Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of lacrimal duct obstruction at 6 months | The recurrence of lacrimal duct obstruction at 6 months after the procedure will be observed. | 6 months | 
| Recurrence of lacrimal duct obstruction at 12 months | The recurrence of lacrimal duct obstruction at 12 months after the procedure will be observed. | 12 months | 
| Recurrence of lacrimal duct obstruction at 24 months | The recurrence of lacrimal duct obstruction at 24 months after the procedure will be observed. | 24 months | 
| Recurrence of lacrimal duct obstruction at 36 months | The recurrence of lacrimal duct obstruction at 36 months after the procedure will be observed. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lacrimal duct obstruction, bicanalicular intubation, dacryocystorinostomy, silicone stent