Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Gordon Buchanan

ORCID ID

Contact details

Department of Surgery
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
+44 (0)20 8864 3232
trust@nwlh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515103409

Study information

Scientific title

Prospective randomised trial comparing computed tomography (CT) and barium enema for colonic investigation in elderly patients

Acronym

Study hypothesis

Colonic investigation in the elderly is often difficult. Colonoscopy, because of sedation, is associated with increased cardiorespiratory complications in older people. Barium enema is widely utilised but approximately 30% of studies are incomplete in the elderly due to technical difficulties with bowel preparation and incontinence. Additionally, bowel preparation may cause faecal incontinence, sleep disturbance and perianal soreness, and has been associated with altered plasma biochemistry. CT scanning has been investigated as a more acceptable alternative in elderly patients. No bowel preparation is necessary, the scan is quick, and no sedation is required. Although CT is unable to detect colonic polyps without full bowel cleansing, these lesions are unimportant in an elderly symptomatic group. Where colorectal carcinoma is the target lesion, previous studies have compared CT followed by barium enema in elderly symptomatic patients and found CT equally able to detect colorectal carcinoma whilst being technically easier to perform and more acceptable to patients. Furthermore, extracolonic pathology is also visible. There are no prospective, randomised trials of this approach, which is the aim of this study.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Surgery: Colonoscopy

Intervention

It is proposed that all hospital clinician referrals for barium enemas in patients over 75 years of age will be randomised to either CT or barium enema. Those randomised to barium enema will be booked in the usual fashion and the enema performed on a routine oupatient list. These patients will be informed of their inclusion in the trial by letter and consent obtained. Those patients not consenting will be sent a barium enema appointment as requested but their data will not be included in the trial. Those patients randomised to CT will be contacted by letter and invited to have a CT scan instead of a barium enema. Consenting patients will undergo a standard CT of the abdomen and pelvis with oral, and rectal and iv contrast as per usual practice. The CT will be reported in the usual fashion with specific comment as to the normality or otherwise of the colon. Results will be available to the referring clinician as per usual practice who is then free to request any further investigation deemed necessary. All patients will undergo long term follow up with reference made to clinical notes, results of further investigations, surgical notes pathology and post mortem reports and cancer registry data. The efficacy of CT (and barium enema) for detection of colorectal carcinoma will be assessed along with the influence on patient diagnosis and management of any extracolonic pathology detected. Patient experiences of the two tests will be investigated by questionnaire.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

CT assessment of colorectal carcinoma will be made as per published criteria. Patient outcome will be assessed by long term clinical follow up and the use of the results of further radiological and pathological investigations.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Adults aged 75 years or older

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

600

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/2001

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West London Hospitals NHS Trust
Harrow, Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North West London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.