Studies on the effects of rectal voltarol administration on the post-operative cytokine profile in serum and peritoneal fluid of patients undergoing major colorectal resection
| ISRCTN | ISRCTN64066379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64066379 |
| Secondary identifying numbers | N0436130458 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 30/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr A M H Smith
Scientific
Scientific
Academic Department of Surgery
Leeds Teaching Hospitals NHS Trust
Clinical Sciences Building
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2003 |
| Completion date | 01/11/2003 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with a diagnosis of primary colorectal carcinoma undergoing elective laparotomy aged over 18. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Department of Surgery
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
