This study was set up to determine the most appropriate way to deal with HPV positive results and associated psychological issues. The MRC funded Trial of Management of Borderline and other Low grade Abnormal smears (TOMBOLA), started recruitment of women in December 1999 and was a seven year multi-centre trial run from Dundee, Aberdeen and Nottingham. The aim of the trial was to:
- determine whether a policy of cytological surveillance or initial colposcopy is the more efficient and effective policy for further investigation and clinical management in women with mild or borderline cervical dyskaryosis.
- determine whether, following colposcopic examination of women with mild or borderline dyskaryosis, immediate large loop excision of the transformation zone (LLETZ) or biopsy and recall for LLETZ, is the more effective and efficient method of treatment.
- evaluate the contribution of HPV testing to the effectiveness and efficiency of the existing procedures for management of women with mild or borderline dyskaryosis.
The study population comprised 10,000 women between the ages of 20 and 59 from the Tayside, Grampian and Nottingham areas that had:
- an index borderline test followed by another test, six months later, which showed either borderline or mild dyskaryosis;
- an index test classified as mildly dyskaryotic
For details of its early findings see;
Psychological effects of a low-grade abnormal cervical smear test result: anxiety and associated factors
British Journal of Cancer (2006) 94, 1253-1262.
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