A Comparison of Endonasal Dacryocystorhinostomy With and Without Silicone Tubes - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00784992

Purpose

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	Intervention	Phase
Nasolacrimal Duct Obstruction	Procedure: Endonasal dacryocystorhinostomy	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Randomised Controlled Trial to Compare Success and Complication Rates in Endonasal Dacryocystorhinostomy Surgery With and Without Silicone Tubes

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention 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)
2: Active Comparator 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.

Arms

Assigned Interventions

1: No Intervention

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)

2: Active Comparator

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784992

Contacts

Contact: Tessa Fayers, BSc MBChB

604-345-0343

tfayers@btinternet.com

Locations

Canada, British Columbia
Eye Care Centre (Clinic)	Recruiting
Vancouver, British Columbia, Canada
Contact: Tessa Fayers, BSc MBChB 604-345-0343 tfayers@btinternet.com
Principal Investigator: Peter Dolman, MD
VGH/UBC (Operating Rooms)	Recruiting
Vancouver, British Columbia, Canada
Contact: Tessa Fayers, BSc MBChB 604-345-0343 tfayers@btinternet.com
Principal Investigator: Peter Dolman, MD

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Peter Dolman, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Peter Dolman MD )
Study ID Numbers:	H08-02025
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00784992
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

NLDO
DCR
silicone tubes
stent

ClinicalTrials.gov processed this record on January 16, 2009