Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/10/2011
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

Prof Derrick F Martin

ORCID ID

Contact details

South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6237
derrick.martin@smuht.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226127781

Study information

Scientific title

Acronym

Study hypothesis

To investigate if splitting the 20 mg of Buscopan (hyoscine-butylbromide) into two doses of 10 mg each, with one dose being administered at the usual point in the examination, and the second dose being administered just before the final images are obtained, will decrease patient discomfort, with no loss of image quality.

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

Condition

Barium enema

Intervention

1. 20 mg of buscopan (hyoscine-butylbromide) at the usual point in examination
2. 20 mg of buscopan (hyoscine-butylbromide) split into two doses of 10 mg each, with one dose being administered at the usual point in the examination, and the second dose being administered just before the final images are obtained

Intervention type

Drug

Phase

Not Specified

Drug names

Barium

Primary outcome measures

Completion of examination

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients attending for barium enema examination, 100 of which will be the controls

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2003

Recruitment end date

01/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Manchester University 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

2005 results in abstract form only: One or two does of buscopan for barium enema examination? Owen A, Limdi S, Raza A, England R, Hogg P, H-U Laasch, Martin D, European Radiology Supplements, Vol 15, Suppl 3, May 2005: C52, P027

Publication citations

Additional files

Editorial Notes