Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/02/2015
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

Miss C J Vaizey

ORCID ID

Contact details

Department of Surgery
Charles Bell House
67-73 Riding House Street
London
W1P 7LD
United Kingdom
+44 (0)20 7636 8333
carolynne.vaizey@nwlh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263107686

Study information

Scientific title

Prospective randomised controlled trial to assess the effect of colonoscopy patient information leaflets on patient knowledge and anxiety

Acronym

Study hypothesis

Do patient information leaflets for colonoscopy improve patient knowledge and anxiety scores?

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

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Colonoscopy

Intervention

1. Standard pre-colonoscopy consultation
2. Standard consultation plus an information leaflet

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Patient knowledge scores
2. Patient anxiety scores (STAI)
3. Patient satisfaction scores

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

01/06/2007

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

80 patients from General Surgery

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2001

Recruitment end date

01/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
London
W1P 7LD
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

University College 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