Prospective randomised controlled study comparing endonasal dacrocystorhinostomy conducted with and without potassium titanyl phosphate (KTP) laser for patients demonstrated to have nasolacrimal duct obstruction

ISRCTN ISRCTN74335571
DOI https://doi.org/10.1186/ISRCTN74335571
Secondary identifying numbers N0106101574
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
17/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Kate Evans
Scientific

Clinical Director of ENT Department
ENT Department
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo investigate whether the different endonasal techniques currently used in dacrocystorhinostomy (DCR) demonstrate any benefit to patients either in the surgical outcome or acceptability of the procedure.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Endonasal dacrocystorhinostomy
Intervention1. Laser endonasal dacrocystorhinostomy
2. Dissection endonasal dacrocystorhinostomy
Intervention typeProcedure/Surgery
Primary outcome measure1. Patient acceptability of the procedure
2. Symptomatic reduction in epiphoria
3. Assessment of complication rates
4. Frequency of stenosis leading to recurrence of symptoms
Secondary outcome measuresNot provided at time of registration
Overall study start date10/07/2001
Completion date31/07/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteria100 patients who have nasolacrimal duct obstruction
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/07/2001
Date of final enrolment31/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clinical Director of ENT Department
Gloucester
GL1 3NN
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Gloucestershire R&D Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2007 Yes No