Obstetrics and gynaecology Urological and Genital Diseases Abnormal findings in specimens from female genital organs
Conditions
Interventions
Interventions updated as of 14/02/2007:
1. Cytological surveillance versus initial colposcopy (R1)
2. Immediate large loop excision of the transformation zone (LLETZ) versus biopsy and selective rec
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. An index smear which indicates mild dyskaryosis, or an index smear which indicates borderline dyskaryosis and a repeat smear taken 6 months later which shows borderline or mild dyskaryosis 2. Resident in Grampian Health Board Area, Tayside Health Board Area or in the Nottingham area with their smear processed by the Nottingham Cervical Screening Laboratory 3. Aged 20-59 years 4. Prior to the index smear, not have had an abnormal smear within the past 3 years 5. Not have had previous treatment for suspected cervical lesions 6. Not be pregnant 7. Not intend to move from the trial areas in the 3-year period following enrolment
Exclusion criteria
Exclusion criteria: Exclusions from R2: If colposcopy is unsatisfactory because the squamo-columnar junction is not visible, the woman will not be randomised but will be treated according to local clinical practice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes relating to effectiveness: 1. Cumulative incidence of CIN2 and CIN3 or more severe disease (referred to as CIN2/3), as determined by biopsy, up to and including the exit examination conducted three years after enrolment 2. Point prevalence of CIN2/3, as determined by biopsy at the exit examination conducted three years after enrolment 3. For medium-term psychosocial effects of cytological surveillance versus initial colposcopy, cumulative proportion of clinically significant anxiety and/or depression, as determined by the Hospital Anxiety and Depression Scale (HADS), during the 34 month period after enrolment in the trial 4. For short-term psychosocial effects of immediate LLETZ versus biopsy and selective recall for LLETZ, (a) mean impact of events score, as determined by the Impact of Events Scale (IES) and (b) proportion of clinically significant anxiety and/or depression as determined by the HADS, at nine weeks after the initial colposcopy Outcomes relating to efficiency: 1. Health related quality of life 2. Total Health Service resource use 3. Non-NHS costs | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed