Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/12/2014
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 EH Sherkawi

ORCID ID

Contact details

Department of General Surgery
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0065117310

Study information

Scientific title

Comparison of the cleansing efficacy of two different bowel preparations for colonoscopy

Acronym

Study hypothesis

To identify the best or the most effective of the two bowel preparation regimes for successful completion of colonoscopy (Picolax, compared to Picolax and Senna).

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

Surgery: Colonoscopy

Intervention

Operator-blinded prospective study with the use of questionnaires comparing the colonoscopy failure rate due to poor bowel preparation associated with the two different laxative regimes (Picolax and Placebo, compared to Picolax and Senna).

Intervention type

Drug

Phase

Not Applicable

Drug names

icolax and Senna

Primary outcome measures

Completion colonoscopy rates (by reaching the caecum)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/12/2002

Overall trial end date

01/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

A total of 374 patients aged above 18 and below 80 are to be recruited.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

187 patients in each treatment group, 374 in total

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/12/2002

Recruitment end date

01/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sunderland Royal Hospital
Sunderland
SR4 7TP
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

City Hospitals Sunderland 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