Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/04/2009
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

Mr Niranjan Raghava

ORCID ID

Contact details

ENT Department
Gloucestershire Royal Hospital (GRH)
Gloucester
GL1 3NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0106163114

Study information

Scientific title

Acronym

Study hypothesis

To establish what type of lubrication is most beneficial when performing nasendoscopy.

Ethics approval

Not provided at time of registration

Study design

Single blind prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgery: Nasendoscopy

Intervention

Group A: water as lubricant
Group B: petroleum jelly as lubricant

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Visual analogue score (VAS) of patient discomfort
2. VAS of picture quality information gained by the doctor
3. VAS of the ease of passage of the nasendoscope

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients requiring nasendoscopy

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

150 - 75 in each group.

Participant exclusion criteria

1. Patients unable to consent
2. Allergic to lubricant
3. Unable to complete VAS
4. Patients who require local anaesthetic

Recruitment start date

01/06/2005

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ENT Department
Gloucester
GL1 3NN
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16620333

Publication citations

  1. Results

    Pothier DD, Raghava N, Monteiro P, Awad Z, A randomized controlled trial: is water better than a standard lubricant in nasendoscopy?, Clin Otolaryngol, 2006, 31, 2, 134-137, doi: 10.1111/j.1749-4486.2006.01173.x.

Additional files

Editorial Notes