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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list