Immunity Factors in Cancer Colon Patients
Conditions
Brief summary
Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.
Interventions
PROCEDUREthoracic epidural
undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections
Sponsors
South Egypt Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Group (EP) received epidural - propofol based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia and Group (EH) received epidural- inhalational based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 20-70 yrs. * ASA class I and II * Elective open surgery for non-metastatic cancer colon stage I,II
Exclusion criteria
* Patient refusal * Known allergy to the study medications * Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids) * Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anti tumour immunity | preoperative and Day 1 postoperatively | Venous blood samples are withdrawn. Samples for measurement of percentage of expression of CD8,CD16 and CD56 will be collected in sodium heparin anticoagulant tubes and will be processed according to manufacturer's instructions,and samples for VEGF-C will be centrifuged at 4000 g. Thereafter, the serum will be stored at -22 C for future measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in pain intensity | 24 hours postoperative | pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain |
Countries
Egypt
Outcome results
None listed