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
Protocol serial number	N0106101574
Sponsor	Department of Health (UK)
Funder	Gloucestershire R&D Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Kate Evans
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Clinical Director of ENT Department

Gloucester
GL1 3NN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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