Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Kate Evans

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17599778

Publication citations

  1. 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.

Additional files

Editorial Notes