Multicentre randomised trial of 'once only' flexible sigmoidoscopy screening for prevention of bowel cancer morbidity and mortality
| ISRCTN | ISRCTN28352761 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28352761 |
| Secondary identifying numbers | G9615910 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 23/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Bowel cancer is the fourth most commonly diagnosed cancer in the UK. Bowel cancers develop slowly from common bowel growths or polyps, so removing them can help prevent cancer. Screening with flexible sigmoidoscopy (also called ‘bowel scope’ or Flexi-scope) involves insertion of a thin flexible tube with a light and camera on the end into the bowel to examine the inner surface. Small bowel polyps can be removed during screening. The aim of the UK Flexible Sigmoidoscopy Screening Trial (UKFSST) was to determine whether having just one flexible sigmoidoscopy screen at around 60 years of age could prevent bowel cancer from developing and reduce the number of deaths from bowel cancer. The trial also aimed to determine how long any benefit lasts, and what is the best age to do the screening examination.
Who can participate?
Men and women who were aged 55–64 years and registered at a participating GP practice between November 1994 and March 1999.
What does the study involve?
The UKFSST was a randomised controlled trial. People who participated in the trial were randomly assigned to receive either flexible sigmoidoscopy screening or no screening (which was the usual care offered at the time of the trial).
What are the possible benefits and risks of participating?
Potential benefits of participating in the UKFSST included the possibility of being assigned to screening and having polyps detected and removed. Possible risks included adverse physical and psychological effects associated with the screening procedure and screening results. Individuals who participated in the trial but who were not assigned to screening received usual care and so were not worse off for having participated.
Where is the study run from?
The UKFSST recruited people from 506 GP practices that served 14 UK hospitals: 11 in England, two in Wales, and one in Scotland. Flexible sigmoidoscopy screening was done in endoscopy clinics at the hospitals.
When is the study starting and how long is it expected to run for?
Recruitment for the study and flexible sigmoidoscopy screening started in November 1994 and was completed in March 1999. The researchers have been following the participants since then, and will continue to follow them through 2024. The data will then be analysed and results written up, and the study will be completed by the 31st March 2027.
Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
Dr Amanda J Cross
amanda.cross@imperial.ac.uk
Contact information
Scientific
Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
 ORCID ID |
0000-0002-0893-2377 |
|---|---|
| amanda.cross@imperial.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Multicentre randomised trial of 'once only' flexible sigmoidoscopy screening for prevention of bowel cancer morbidity and mortality |
| Study acronym | UKFSST |
| Study hypothesis | Primary aims: 1. To quantify the reduction in incidence and mortality 2. To determine the duration of efficacy of a single flexible sigmoidoscopy 3. To determine the optimum age for the examination 4. To evaluate health service research implications to permit an informed decision at the end of the trial about the suitability for implementation within a national screening programme The criteria to be evaluated include: 1. Uptake, acceptability and impact 2. Quality control of the procedure 3. Cost-effectiveness |
| Ethics approval(s) | South East MREC, ref: MREC/03/1/002 |
| Condition | Colorectal cancer |
| Intervention | 'Once only' flexible sigmoidoscopy screening/control |
| Intervention type | Other |
| Primary outcome measure | Incidence, mortality from colorectal cancer |
| Secondary outcome measures | Psychological morbidity, costs to the NHS |
| Overall study start date | 01/07/1995 |
| Overall study end date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Recruitment closed after randomising over 170,000 people |
| Total final enrolment | 167882 |
| Participant inclusion criteria | All 55-64 year old men and women from selected general practices |
| Participant exclusion criteria | 1. If incapable of providing informed consent 2. Patients with a personal or family history of bowel cancer (greater than two family members) 3. A recent sigmoidoscopy or colonoscopy 4. Severe illness or life expectancy of less than 5 years |
| Recruitment start date | 01/07/1995 |
| Recruitment end date | 28/02/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W2 1PG
United Kingdom
Sponsor information
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
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 | 31/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publications of secondary endpoint analyses and further follow-up of the cohort are planned in high-impact peer reviewed journals between 2019 and 2028. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the terms and conditions of the data sharing agreements the researchers hold with third party data providers and their section 251 approval. However, anonymised, aggregated data may be made available upon application to the CSPRG: https://www.csprg.org.uk/patient-data/ and https://www.csprg.org.uk/contact-us/. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | baseline results | 13/04/2002 | Yes | No | |
| Results article | results | 01/03/2003 | Yes | No | |
| Results article | results | 08/05/2010 | Yes | No | |
| Results article | results | 01/04/2017 | Yes | No | |
| Results article | results | 01/10/2018 | Yes | No | |
| Results article | results | 01/03/2019 | Yes | No | |
| Basic results | 15/03/2019 | 26/03/2019 | No | No | |
| Other publications | Between-center variation in adenoma detection rates | 01/05/2004 | 05/05/2022 | Yes | No |
| Other publications | Patient-reported outcomes following flexible sigmoidoscopy screening | 01/12/2012 | 05/05/2022 | Yes | No |
| Other publications | Uptake of Flexible Sigmoidoscopy at 14 months | 20/09/2015 | 05/05/2022 | Yes | No |
| Other publications | efficacy and acceptability of two methods of self administered bowel preparation for flexible sigmoidoscopy screening | 03/06/2000 | 05/05/2022 | Yes | No |
| Other publications | pilot examining rates of attendance, yield of neoplasia, and adverse effects | 01/04/1998 | 05/05/2022 | Yes | No |
| Other publications | uptake of population-based, flexible sigmoidoscopy screening | 21/07/2010 | 05/05/2022 | Yes | No |
| Protocol article | trial design | 01/09/2001 | 05/05/2022 | Yes | No |
| Results article | Associations between Adenoma Detection Rates and Long-Term Colorectal Cancer Incidence and Mortality | 12/09/2020 | 05/05/2022 | Yes | No |
| Other publications | 15-Year Benefits of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality : A Pooled Analysis of Randomized Trials | 01/11/2022 | 14/11/2023 | Yes | No |
| Results article | 21-year follow-up | 19/07/2024 | 23/07/2024 | Yes | No |
Additional files
- ISRCTN28352761_BasicResults_15Mar19.pdf
- Uploaded 26/03/2019
Editorial Notes
23/07/2024: Publication reference added.
14/11/2023: Publication reference added.
05/05/2022: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added.
26/03/2019: Publication and dissemination plan added. The basic results of this trial have been uploaded as an additional file.
22/03/2019: Publication reference and IPD sharing statement added.
15/02/2019: The following changes were made to the trial record:
1. Plain English summary and trial website added.
2. Contact details updated.
3. The overall trial end date was changed from 31/12/2015 to 31/03/2027.
4. Publication references added.
27/02/2017: Publication reference added.
28/02/2014: The following changes were made to the trial record:
1. The target number of participants field was changed from '195,000 - Recruitment ongoing' to 'Recruitment closed after randomising over 170,000 people'.
2. The overall trial end date was changed from 31/12/2010 to 31/12/2015.
