Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
30/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr A M H Smith

ORCID ID

Contact details

Academic Department of Surgery
Leeds Teaching Hospitals NHS Trust
Clinical Sciences Building
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130458

Study information

Scientific title

Acronym

Study hypothesis

To establish the effect of voltarol on the nature and levels of the cytokines present in the post-operative peritoneum and in serum. Any difference detected will be used to pursue further laboratory based research into the potential benefit of cyclo-oxygen

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

Treatment

Patient information sheet

Condition

Surgery: Colorectal

Intervention

Not provided at time of registration

30/08/2012: Please note that this trial was stopped due to a lack of participants.

Intervention type

Drug

Phase

Not Applicable

Drug names

voltarol

Primary outcome measures

Concentration of cytokines interleukin-IB (IL-IB) interleukin 6 (IL-6) and tumour necrosis factor-α (TNF-α) will be measured in the samples collected using the luminex platform. Prostaglandins E2 and F1 will also be measured.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

01/11/2003

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Patients with a diagnosis of primary colorectal carcinoma undergoing elective laparotomy aged over 18.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2003

Recruitment end date

01/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Surgery
Leeds
LS9 7TF
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

Leeds Teaching 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