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 |
| Protocol serial number | N0206121779 |
| Sponsor | Department of Health (UK) |
| Funder | Royal Liverpool Children's NHS Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Hypospadias repair |
| Intervention | New dressing technique vs standard care |
| Intervention type | Other |
| Primary outcome measure(s) | Removal time for dressing |
| Key secondary outcome measure(s) | 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 |
| Completion 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 sample size at registration | 60 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ward K3
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
