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Trial of management of borderline and other low-grade abnormal smears
ISRCTN ISRCTN34841617
DOI 10.1186/ISRCTN34841617
ClinicalTrials.gov identifier
EudraCT number
Public title Trial of management of borderline and other low-grade abnormal smears
Scientific title
Acronym TOMBOLA
Serial number at source G9700808
Study hypothesis The purpose of this randomised trial is:
1. To determine whether a policy of cytological surveillance or initial colposcopy is the more effective and efficient policy for further investigation and clinical management in women with borderline abnormality or mild dyskaryosis.
2. To determine whether, following colposcopic examination of women with mild or borderline dyskaryosis, immediate LLETZ or biopsy and recall if appropriate for LLETZ, is the more effective and efficient method of treatment. 3. To evaluate the contribution of human papilloma virus (HPV) testing to the effectiveness and efficiency of the existing procedures for management of women with mild or borderline dyskaryosis
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Obstetrics and gynaecology
Participants - 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.
Participants - 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
Anticipated start date 14/06/1999
Anticipated end date 31/05/2008
Status of trial Completed
Patient information material
Target number of participants Modified 13/08/09: Originally 10,000. Revised following changes to the eligibility criteria to 4483 (agreed by TSC in May 2000, ratified by MRC in January 2001). Closed to recruitment - in follow-up.
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 recall for LLETZ (R2)

Interventions provided at time of registration:
Cytological surveillance/initial colposcopy
Primary outcome measure(s) 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 outcome measure(s) Not provided at time of registration
Sources of funding Medical Research Council (MRC) (UK)
Trial website http://www.tombola.ac.uk/index.shtml
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16765101
2. 2006 reasons for participation in http://www.ncbi.nlm.nih.gov/pubmed/17060217
3. 2009 results on cytological surveillance versus initial colonoscopy in http://www.ncbi.nlm.nih.gov/pubmed/19638646
4. 2009 results on large loop excision versus biopsy and selective recall in http://www.ncbi.nlm.nih.gov/pubmed/19638647
5. 2009 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/19638648
6. 2009 results on comparison of EQ-5D and HADS in http://www.ncbi.nlm.nih.gov/pubmed/19811595
7. 2010 management of low-grade results in http://www.ncbi.nlm.nih.gov/pubmed/20374607
8. 2011 psychosocial impact results in http://www.ncbi.nlm.nih.gov/pubmed/21179033
9. 2012 default from follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/21366734
10. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22921577
11. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24386076
Contact name Professor  Julian  Little
  Address Department of Medicine & Therapeutics
University of Aberdeen
Foresterhill House Annex
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
  Email
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 25/10/2000
Last edited 09/01/2014
Date ISRCTN assigned 25/10/2000
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