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
Secondary identifying numbers N0064069074
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

Department of Gynaecology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Phone +44 (0)121 507 4377

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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) studiedUrological and Genital Diseases: Telecolposcopy
InterventionImpact of telecolposcopy screening
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/2000
Completion date01/04/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants400
Key inclusion criteriaRecruiting 200 women in each arm
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/2000
Date of final enrolment01/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Gynaecology
Birmingham
B18 7QH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan