Long Term Effectiveness of Dacryocystorinostomy With and Without Bicanalicular Intubation

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2022

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.

Interventions

  • Procedure: dacryocystorinostomy
    • Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.

Arms, Groups and Cohorts

  • Experimental: Dacryocystorinostomy with bicanalicular intubation
    • Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy with bicanalicular intubation.
  • Experimental: Dacryocystorinostomy without bicanalicular intubation
    • Patients with lacrimal duct obstruction enrolled into this study arm will undergo dacryocystorinostomy without bicanalicular intubation.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Ostrava
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pavel Komínek, prof.,MD,PhD,MBA, Principal Investigator, University Hospital Ostrava
  • Overall Contact(s)
    • Petr Vávra, Ass.Prof.,MD,PhD, 0042059737, petr.vavra@fno.cz

References

Nomura K, Arakawa K, Sugawara M, Hidaka H, Suzuki J, Katori Y. Factors influencing endoscopic dacryocystorhinostomy outcome. Eur Arch Otorhinolaryngol. 2017 Jul;274(7):2773-2777. doi: 10.1007/s00405-017-4541-8. Epub 2017 Mar 20.

Coumou AD, Genders SW, Smid TM, Saeed P. Endoscopic dacryocystorhinostomy: long-term experience and outcomes. Acta Ophthalmol. 2017 Feb;95(1):74-78. doi: 10.1111/aos.13217. Epub 2016 Aug 29.

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