Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Not Applicable

Completed

• Conditions: Lacrimal Duct Obstruction
• Interventions: Procedure: dacryocystorinostomy

• Registration Number: NCT03960996
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Study Start: 2019-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dacryocystorinostomy without bicanalicular intubation	dacryocystorinostomy	Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation.
Dacryocystorinostomy with bicanalicular intubation	dacryocystorinostomy	Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation.

Primary Outcome Measures

Name	Time	Method
Recurrence of lacrimal duct obstruction at 6 months	6 months	The recurrence of lacrimal duct obstruction at 6 months after the procedure will be observed.
Recurrence of lacrimal duct obstruction at 12 months	12 months	The recurrence of lacrimal duct obstruction at 12 months after the procedure will be observed.
Recurrence of lacrimal duct obstruction at 36 months	36 months	The recurrence of lacrimal duct obstruction at 36 months after the procedure will be observed.
Recurrence of lacrimal duct obstruction at 24 months	24 months	The recurrence of lacrimal duct obstruction at 24 months after the procedure will be observed.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia