Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Prof Wendy S Atkin
ORCID ID
Contact details
Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 20 7594 3369
w.atkin@imperial.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
HTA 04/33/01
Study information
Scientific title
Randomised trial of colonoscopic surveillance intervals after removal of colorectal adenomas
Acronym
Study hypothesis
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.
Study design
Single-centre stratified randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
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
Overall study end date
01/01/1990
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
785 patients were recruited
Participant exclusion criteria
1. History of inflammatory bowel disease
2. Surgical resection for CRC
3. A rectal villous adenoma
4. Patients older than 70 years
Recruitment start date
01/01/1979
Recruitment end date
01/01/1990
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Imperial College London
Kensington
London
W2 1PG
United Kingdom
Sponsor information
Organisation
Imperial College London
Sponsor details
Clinical Research Governance Office
G02
Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
+44 (0)20 7594 1554
clinicalresearchgovernanceoffice@imperial.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 05/03/1992 | Yes | No |