A prospective randomised controlled clinical trial to evaluate methods of dressing removal, in respect of time and comfort, for boys undergoing hypospadias repair
| ISRCTN | ISRCTN15032217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15032217 |
| Secondary identifying numbers | N0206121779 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms C Sanders
Scientific
Scientific
Ward K3
Royal Liverpool Children's NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| Condition | Urological and Genital Diseases: Hypospadias repair |
| Intervention | New dressing technique vs standard care |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/09/2003 |
| Overall study end date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 15 Months |
| Upper age limit | 5 Years |
| Sex | 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 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 exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/09/2003 |
| Recruitment end date | 01/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ward K3
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Royal Liverpool Children's NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2003 | Yes | No |
