Cancer: Colorectal Cancer Colorectal
Conditions
Interventions
HYPOTHESES TO BE TESTED IN THIS STUDY:
ONE:
Null Hypothesis: There is no difference in the postoperative levels of immunosupression as a result of mini-laparotomy compared to conventional laparotomy
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: IDENTIFICATION OF PATIENTS Patients with colorectal cancer diagnosed at St George?s Hospital from the 1st November 2004 will be considered for this study. It must have been agreed by the patient and clinician that surgical resection of the cancer is appropriate and that the patient is willing to undergo surgery at St George?s Hospital. APPROACHING PATIENTS Once the decision is made for surgery to go ahead the patient will be introduced to the chief investigator of the study, who is a member of the colorectal team, preferably in the same clinic or when the patient is first available / willing to have a discussion. A face to face discussion will be held with the patient and or any friend / relative that they wish to be involved. RECRUITING PATIENTS In the initial interview the study will be explained including the full implications to the patient, the risks, the additional inconveniences and investigations along with the potential benefits. If at that time the patient wishes to consider involvement a full information sheet will be given including a contact number of the chief investigator if there are any further questions. Once the patient has had time to consider inclusion in to the study or not and is in agreement an informed consent form will be signed. It should be noted that there will be no delay in arranging a date for surgery while the patient considers their involvement in the study. Inclusion criteria: 1. Clinical diagnosis of adenocarcinoma of the colon/rectum 2. 18 years old or older 3. Willing to consent & surgically resectable tumours
Exclusion criteria
Exclusion criteria: 1. Patients with intestinal obstruction or perforation 2. Concurrent or previous malignant tumours or familial adenomatous polyposis 3. Patients with known metastases 4. Patients with gross psychiatric illness & pts with pre-existing inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the amount of acute inflammatory markers (the cytokines IL-6, IL-2, IL-1beta and TNF-alpha) measured from venous blood samples taken 1 day pre operation, day 1, day 5 and 2 months post surgery in the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed