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21 March 2013
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| [ Print-friendly version ] |
| 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 |
| 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 |
| 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 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 25/10/2000 |
| Last edited | 11/09/2012 |
| Date ISRCTN assigned | 25/10/2000 |
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