Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0106101574
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Endonasal dacrocystorhinostomy
Intervention
1. Laser endonasal dacrocystorhinostomy
2. Dissection endonasal dacrocystorhinostomy
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
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 trial start date
10/07/2001
Overall trial end date
31/07/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
100 patients who have nasolacrimal duct obstruction
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/07/2001
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Director of ENT Department
Gloucester
GL1 3NN
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gloucestershire R&D Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17599778
Publication citations
-
Results
Maini S, Raghava N, Youngs R, Evans K, Trivedi S, Foy C, Mackintosh G, Endoscopic endonasal laser versus endonasal surgical dacryocystorhinostomy for epiphora due to nasolacrimal duct obstruction: prospective, randomised, controlled trial., J Laryngol Otol, 2007, 121, 12, 1170-1176, doi: 10.1017/S0022215107009024.