Study of colonoscopic surveillance intervals after removal of colorectal adenomas

ISRCTN ISRCTN02411483
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Wendy S Atkin
Scientific

Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom

Phone +44 20 7594 3369
Email w.atkin@imperial.ac.uk

Study information

Study designSingle-centre stratified randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleRandomised trial of colonoscopic surveillance intervals after removal of colorectal adenomas
Study objectivesThe 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) studiedColorectal cancer
InterventionStudy 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 typeOther
Primary outcome measureThe 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 measuresDetection of any adenoma during follow-up.
Overall study start date01/01/1979
Completion date01/01/1990

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants785 patients were recruited
Key inclusion criteria1. Patients attending St Mark’s 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 criteria1. History of inflammatory bowel disease
2. Surgical resection for CRC
3. A rectal villous adenoma
4. Patients older than 70 years
Date of first enrolment01/01/1979
Date of final enrolment01/01/1990

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Imperial College London
Kensington
London
W2 1PG
United Kingdom

Sponsor information

Imperial College London
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
Email clinicalresearchgovernanceoffice@imperial.ac.uk
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom
Cancer Research UK
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.