A randomised controlled trial of cytological surveillance versus patient choice between surveillance and colposcopy in managing mildly abnormal cervical smears

ISRCTN	ISRCTN14634238
DOI	https://doi.org/10.1186/ISRCTN14634238
Secondary identifying numbers	NCP2/R207

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 08/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cervical screening (also known as a smear test) involves a doctor or nurse using a small brush to collect cells from the surface of the cervix (the entrance to the womb from the vagina). Detecting and removing abnormal cells can prevent cervical cancer. The cervical screening guidelines recommend a repeat smear after six months, with colposcopy (where a magnifying device is used to look at the cervix) if the mildly abnormal smear persists, and that “colposcopy for all’’ would involve excessive and wasteful intervention and cause unnecessary anxiety for many women. The aim of this study is to determine whether enabling a woman to choose between a management policy of repeat smears or colposcopy produces a better outcome.

Who can participate?
Women aged 20 to 60 with mildly abnormal cervical smear test results

What does the study involve?
Women are randomly allocated to either the choice group or the no-choice group. Women allocated to the no-choice group had a repeat smear at 6 months. If the smear was normal, a further repeat smear was performed at 12 months and if again normal, the women returned to routine screening. If the smear at six months is abnormal, colposcopy is undertaken. Treatment consists of diathermy loop excision, which involves using a thin heated wire loop to remove the area of the cervix where the abnormal cells are. Patients are followed up six months later by means of smear and colposcopy. If the 12-month smear is abnormal following a normal smear at 6 months, then those women are referred for colposcopy and treatment. Women allocated to the choice group choose between colposcopy and a repeat smear at 6 months, after an opportunity to discuss the two options. Those who choose repeat smears are managed exactly as described above for the no-choice group. Women who select colposcopy are managed according to the colposcopy procedure described above.

What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. As it is necessary for those women with an abnormal smear to be referred to the colposcopy clinic, it could be argued that this visit could make them unnecessarily anxious and more so than if they were recalled by the GP.

Where is the study run from?
St Mary’s Hospital by the University of Manchester (UK)

When is the study starting and how long is it expected to run for?
January to December 2002

Who is funding the study?
National Health Service Research and Development Cancer Programme (UK)

Who is the main contact?
Prof. Henry Kitchener
henry.kitchener@manchester.ac.uk

Contact information

Prof Henry Kitchener
Scientific

Department of Obstetrics & Gynaecology and Reproductive Health
University of Manchester
St Mary's Hospital
Whitworth Park
Manchester
M13 0JH
United Kingdom

Phone	+44 (0)161 276 6421/6461
Email	henry.kitchener@manchester.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of cytological surveillance versus patient choice between surveillance and colposcopy in managing mildly abnormal cervical smears
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer (neoplasms): Cervix
Intervention	1. Normal procedure of repeat smear in 6 months. If normal, a further repeat smear at 12 months. If smear at 6 months was abnormal, colposcopy was undertaken. 2. Patient choice given between colposcopy and 6-months repeat smear. Women who chose colposcopy were managed as for normal procedure arm.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2002
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	476
Key inclusion criteria	Women with mildly abnormal cervical smears
Key exclusion criteria	Pregnancy or abnormal vaginal bleeding.
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M13 0JH
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

NHS Cancer National Research and Development Programme

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	01/01/2004		Yes	No

Editorial Notes

08/04/2016: Plain English summary added.