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 |
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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
Scientific
Clinical Director of ENT Department
ENT Department
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | To 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) studied | Surgery: Endonasal dacrocystorhinostomy |
Intervention | 1. Laser endonasal dacrocystorhinostomy 2. Dissection endonasal dacrocystorhinostomy |
Intervention type | Procedure/Surgery |
Primary outcome measure | 1. 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 measures | Not provided at time of registration |
Overall study start date | 10/07/2001 |
Completion date | 31/07/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 100 |
Key inclusion criteria | 100 patients who have nasolacrimal duct obstruction |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 10/07/2001 |
Date of final enrolment | 31/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Director of ENT Department
Gloucester
GL1 3NN
United Kingdom
GL1 3NN
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Gloucestershire R&D Consortium (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2007 | Yes | No |