Condition category
Urological and Genital Diseases
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

Ms C Sanders

ORCID ID

Contact details

Ward K3
Royal Liverpool Children's NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0206121779

Study information

Scientific title

Acronym

Study hypothesis

Does a new dressing technique used around the penile wound post hypospadias repair reduce the time taken to remove the dressing and reduce the pain experienced by children and parental anxiety?

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

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Urological and Genital Diseases: Hypospadias repair

Intervention

New dressing technique vs standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Removal time for dressing

Secondary outcome measures

1. Self reported parent/carer anxiety pre and post dressing removal
2. Differences in child pain score (0-4 visual analogue scale) rated by parent and nurse

Overall trial start date

01/09/2003

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

All boys undergoing any type of hypospadias repair that would require a form of dressing post operatively, between the ages of 15 months, up to 5 years.

Participant type

Patient

Age group

Child

Gender

Male

Target number of participants

A sample size of 30 children in each group will be recruited. Control group or treatment group. Total = 60.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2003

Recruitment end date

01/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ward K3
Liverpool
L12 2AP
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

Royal Liverpool Children's NHS Trust (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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12937382

Publication citations

  1. Results

    Sanders C, Comparison of dressing removal following hypospadias repair., Br J Nurs, 2003, 12, 15 Suppl, S21-8, doi: 10.12968/bjon.2003.12.Sup3.11433.

Additional files

Editorial Notes