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










Project Summary and Objectives:

There is uncertainty as to the optimal management of mildly abnormal smears.
One approach is a repeat smear in 6 months to enable regression to normal.
The alternative is to colposcope, with the advantages of prompt diagnosis and reducing default.


There is a lack of professional concensus as to which of these two is superior.
A major consideration is psychological morbidity and quality of life.
The objective of the study is to determine whether the psychological outcome for women with mildly abnormal smears is better if they are able to decide the first stage of their management.

500 women with a mildly dyskaryotic smear or recurrent borderline smear will be randomised either to cytological surveillance with colposcopy if smears remain abnormal or to the patient choosing between cytological surveillance or colposcopy.

Primary outcomes will include psychological morbidity, quality of life and rates of default in each arm.


Secondary outcomes will include the proportion of women in each arm requiring colposcopy and treatment.


Further information can be obtained from:

Professor Henry Kitchener
Professor of Gynaecological Oncology
Department of Obstetrics & Gynaecology and Reproductive Health Care
University of Manchester
St. Mary's Hospital
Whitworth Park
Manchester    M13 0JH

UK







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Last updated 22 November 2004
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