Prospective randomised trial comparing computed tomography (CT) and barium enema for colonic investigation in elderly patients
| ISRCTN | ISRCTN65254874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65254874 |
| Secondary identifying numbers | N0515103409 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr Gordon Buchanan
Scientific
Scientific
Department of Surgery
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
| Phone | +44 (0)20 8864 3232 |
|---|---|
| trust@nwlh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prospective randomised trial comparing computed tomography (CT) and barium enema for colonic investigation in elderly patients |
| 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/06/2001 |
| Overall study end date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 600 |
| Participant inclusion criteria | Adults aged 75 years or older |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 01/06/2001 |
| Recruitment end date | 30/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
North West London Hospitals NHS Trust
Harrow, Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
North West London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Editorial Notes
30/09/2016: No publications found, verifying study status with principal investigator.
