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A Comparison of Endonasal Dacryocystorhinostomy With and Without Silicone Tubes

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ClinicalTrials.gov Identifier: NCT00784992
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
Aim of study is to investigate whether the use of silicone tubes in endonasal DCR surgery increases the success rate and / or complication rate compared to surgery without tubes.

Condition or disease Intervention/treatment Phase
Nasolacrimal Duct Obstruction Procedure: Endonasal dacryocystorhinostomy Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare Success and Complication Rates in Endonasal Dacryocystorhinostomy Surgery With and Without Silicone Tubes
Study Start Date : November 2008
Actual Primary Completion Date : June 2, 2016
Actual Study Completion Date : June 2, 2016

Arm Intervention/treatment
No Intervention: 1
Endonasal DCR with silicone tubes (this is the control group since it is the standard procedure / gold standard, although the evidence base for the use of tubes is lacking, hence the need for this trial)
Active Comparator: 2
Endonasal DCR without silicone tubes (this is the 'intervention' arm)
Procedure: Endonasal dacryocystorhinostomy

The standard dacryocystorhinostomy operation performed in this centre uses silicone tubes to stent open the newly created ostium between the lacrimal sac and the nasal cavity. However many surgeons in other departments / countries around the world perform the surgery without tubes. No large well-conducted RCT has been published comparing success rates / complication rates for the two techniques. For this study the control group is the arm which receives tubes (our standard procedure) and the 'interventional' group is the arm not receiving tubes.

Details of the operative technique for endonasal DCR with tubes can be found in the following reference: Dolman PJ. Comparison of external dacryocystorhinostomy with nonlaser endonasal dacryocystorhinostomy. Ophthalmology. 2003 Jan;110(1):78-84. The group that will not receive tubes will undergo the same procedure except that the insertion of tubes will be omitted.




Primary Outcome Measures :
  1. The primary end point will be functional success, determined by patient-reported symptoms. This will be assessed a minimum of six months post-operatively. In patients with tubes these will be removed at 3 months post-operatively. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The secondary end point will be anatomical success, as measured by patency of nasolacrimal irrigation at 6 months post-operatively. In patients with tubes these will be removed at 3 months post-operatively. [ Time Frame: 6 months ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients (> 16 years) undergoing primary DCR for NLDO who have given fully informed consent to be in the trial

Exclusion Criteria:

  • Age less than 16 years
  • Previous ipsilateral DCR or nasal surgery
  • Canalicular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784992


Locations
Canada, British Columbia
Eye Care Centre (Clinic)
Vancouver, British Columbia, Canada
VGH/UBC (Operating Rooms)
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Peter Dolman, MD University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00784992     History of Changes
Other Study ID Numbers: H08-02025
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by University of British Columbia:
NLDO
DCR
silicone tubes
stent