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 |
| Protocol serial number | N0436130458 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | voltarol |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 |
| 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
- United Kingdom
- England
Study participating centre
Academic Department of Surgery
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
