Trial of management of borderline and other low-grade abnormal smears

ISRCTN	ISRCTN34841617
DOI	https://doi.org/10.1186/ISRCTN34841617
Secondary identifying numbers	G9700808

Submission date: 25/10/2000
Registration date: 25/10/2000
Last edited: 18/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Julian Little
Scientific

Department of Medicine & Therapeutics
University of Aberdeen
Foresterhill House Annex
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Trial of management of borderline and other low-grade abnormal smears
Study acronym	TOMBOLA
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Obstetrics and gynaecology
Intervention	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
Intervention type	Other
Primary outcome measure	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 measures	Not provided at time of registration
Overall study start date	14/06/1999
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Modified 13/08/2009: Originally 10,000. Revised following changes to the eligibility criteria to 4483 (agreed by TSC in May 2000, ratified by MRC in January 2001)
Key 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
Key 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
Date of first enrolment	14/06/1999
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University of Aberdeen

Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Other publications	reasons for participation	01/10/2006	Yes	No
Protocol article	protocol	01/10/2006	Yes	No
Results article	results on cost effectiveness	28/07/2009	Yes	No
Results article	results on cytological surveillance versus initial colonoscopy	28/07/2009	Yes	No
Results article	results on large loop excision versus biopsy and selective recall	28/07/2009	Yes	No
Results article	results on comparison of EQ-5D and HADS	01/10/2009	Yes	No
Results article	management of low-grade results	01/05/2010	Yes	No
Results article	psychosocial impact results	18/01/2011	Yes	No
Results article	default from follow-up results	01/06/2012	Yes	No
Results article	results	01/12/2012	Yes	No
Results article	results	30/12/2013	Yes	No
Results article	results	01/01/2016	Yes	No