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

ISRCTN	ISRCTN34841617
DOI	https://doi.org/10.1186/ISRCTN34841617
Protocol serial number	G9700808
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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

Contact information

Dr Julian Little
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	4483
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

United Kingdom
Scotland

Study participating centre

University of Aberdeen

Aberdeen
AB25 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	01/10/2006		Yes	No
Other publications	reasons for participation	01/10/2006		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes