Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
13/10/2011
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

Dr Christopher Fraser

ORCID ID

Contact details

Wolfson Unit for Endoscopy
North West London Hospitals NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom
+44 020 8235 4225
chris.fraser@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515171640

Study information

Scientific title

Acronym

Study hypothesis

To determine whether taking bowel preparation (Citramag and Senna) or a medicine to speed up transit through the stomach (Metoclopramide) will improve the quality of images seen, increase the transit through the small bowel, and increase the rate of completion of capsule endoscopy.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Capsule endoscopy

Intervention

Randomised controlled study.

Intervention type

Drug

Phase

Not Specified

Drug names

Citramag and Senna or Metoclopramide

Primary outcome measures

Bowel visualisation, stomach and small intestinal transit time and capsule study completion rates (to the caecum)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

150 patients, 50 of which will be in the control group.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Unit for Endoscopy
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19152909

Publication citations

  1. Results

    Postgate A, Tekkis P, Patterson N, Fitzpatrick A, Bassett P, Fraser C, Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study., Gastrointest. Endosc., 2009, 69, 6, 1120-1128, doi: 10.1016/j.gie.2008.06.044.

Additional files

Editorial Notes