A randomised trial of telecolposcopy screening in the management of women with minor cervical smear abnormalities
| ISRCTN | ISRCTN50023379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50023379 |
| Protocol serial number | N0064069074 |
| Sponsor | Department of Health (UK) |
| Funder | Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/06/2014
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Ian Etherington
Scientific
Scientific
Department of Gynaecology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
| Phone | +44 (0)121 507 4377 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | The primary objective of the study is to evaluate the impact of telecolposcopy screening on the number of visits women have to the colposcopy clinic before discharge to community cytology. Secondary objectives are: 1. To evaluate the anxiety levels experienced by women in the study and control groups. 2. To evaluate the cost impact to the Screening Programme of introducing telecolposcopy 3. To evaluate the impact of such screening on the time interval between the first abnormal smear and the detection of high-grade cervical intraepithelial neoplasia (CIN) 4. To evaluate the ability of telecolposcopy screening to differentiate between grades of CIN |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Telecolposcopy |
| Intervention | Impact of telecolposcopy screening |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 400 |
| Key inclusion criteria | Recruiting 200 women in each arm |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Gynaecology
Birmingham
B18 7QH
United Kingdom
B18 7QH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
