Study of colonoscopic surveillance intervals after removal of colorectal adenomas
ISRCTN | ISRCTN02411483 |
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DOI | https://doi.org/10.1186/ISRCTN02411483 |
Secondary identifying numbers | HTA 04/33/01 |
- Submission date
- 07/06/2011
- Registration date
- 08/06/2011
- Last edited
- 02/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Bowel polyps are small, benign (harmless) growths found on the inner lining of the colon (end part of the large intestine) or rectum. They are not usually cancerous, however if they are found they should be removed as some will eventually turn into cancer if left untreated. People who have been found to have bowel polyps need to undergo colposcopies in order to monitor the growth of polyps and check for new ones. This involves having a thin, flexible tube with a camera on the end being inserted into the anus to look at the lining of the large intestine. The aim of this study is to find out how often these colonoscopies should take place to best monitor patients with bowel polyps to prevent the development of cancer.
Who can participate?
Patients aged between 20 and 71 attending St Mark’s Hospital between 1979-1990 with bowel polyps or bowel cancer.
What does the study involve?
Patients are divided into groups depending on their risk of developing bowel cancer. Those who have a high risk are randomly allocated to undergo colonoscopies at 12-18 month intervals or every three years. Those who have a low risk are randomly allocated to undergo examinations every three years or every five years. Throughout the study, all patients are monitored for the development of bowel cancer and at the end of the study, the best possible frequency of monitoring is determined.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
January 1979 to January 1990
Who is funding the study?
1. National Institute for Health Research, Health Technology Assessment Programme (UK)
2. Cancer Research UK (UK)
Who is the main contact?
Professor Wendy Atkin
w.atkin@imperial.ac.uk
Contact information
Scientific
Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
Phone | +44 20 7594 3369 |
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w.atkin@imperial.ac.uk |
Study information
Study design | Single-centre stratified randomised trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | No participant information sheet available |
Scientific title | Randomised trial of colonoscopic surveillance intervals after removal of colorectal adenomas |
Study objectives | The study was designed to compare the effectiveness of different frequencies of colonoscopic examination, with polypectomy of all adenomas detected, for preventing advanced adenomas and colorectal cancer (CRC). A secondary aim of this study was to identify baseline risk factors for diagnosis of advanced neoplasia (adenomas and CRC) during follow-up. This approach was adopted to determine if a subgroup of patients might benefit from more intense surveillance. |
Ethics approval(s) | Not applicable because ethical approval standards were not in place when the study was started in the late 1970s early 1980s. |
Health condition(s) or problem(s) studied | Colorectal cancer |
Intervention | Study of colonoscopic surveillance regimens. Allocation to regimen was by minimisation method. Patients were stratified into high and low risk groups by their characteristics at entry (age, malignancy and multiplicity of adenomas). Then within the high risk group the participants could be randomised to frequent follow-up or exams at three year intervals. Within the low risk group paricipants could be randomised to exams at three year intervals or exams at five year intervals. No masking, all participants received surveillance. High risk patients: Three exams at 12-18 month intervals and 3-yearly follow-up thereafter (median endoscopic surveillance - 7.0 yrs, median passive follow-up - 18.6 yrs) or exams at three year intervals (median endoscopic surveillance - 6.6 yrs, median passive follow-up - 18.8 yrs) Low risk patients: Exams at three year intervals (median endoscopic surveillance - 9.1 yrs, median passive follow-up - 21.7 yrs) or exams at five year intervals (median endoscopic surveillance - 6.3 yrs, median passive follow-up - 21.8 yrs) |
Intervention type | Other |
Primary outcome measure | The primary outcome was the diagnosis of advanced neoplasia (advanced adenomas or colorectal cancer) during follow-up. An advanced adenoma was defined as an adenoma ≥ 10 mm or with high grade dysplasia. |
Secondary outcome measures | Detection of any adenoma during follow-up. |
Overall study start date | 01/01/1979 |
Completion date | 01/01/1990 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 785 patients were recruited |
Key inclusion criteria | 1. Patients attending St Marks Hospital between 1979-1990, with endoscopically removed adenomas or malignant lesions 2. 468 males and 317 females in the study, aged between 20 and 71 |
Key exclusion criteria | 1. History of inflammatory bowel disease 2. Surgical resection for CRC 3. A rectal villous adenoma 4. Patients older than 70 years |
Date of first enrolment | 01/01/1979 |
Date of final enrolment | 01/01/1990 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
W2 1PG
United Kingdom
Sponsor information
University/education
Clinical Research Governance Office
G02, Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
Phone | +44 (0)20 7594 1554 |
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clinicalresearchgovernanceoffice@imperial.ac.uk | |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 05/03/1992 | Yes | No |
Editorial Notes
02/03/2017: A plain English summary has been added. Publication reference added.
04/03/2016: No publications found, verifying study status with principal investigator.