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Evaluation of the inflammatory response to minilaparotomy compared to conventional laparotomy in the surgical resection of colorectal cancer including its influence on long term survival and local recurrence

ABSTRACT: Study hypothesis: To compare standard surgical approach to minilaparotomy in patients undergoing surgical resection for colorectal cancer. Once group will have surgery in the conventional manner and the other will have it performed using a mini-laparotomy. A mini-laparotomy being where the incision, through which the abdominal cavity is entered to reach the cancer, is 15cm or less; whereas conventionally a cut is made along the entire length of the abdomen. We aim to show that there is a reduced inflammatory response to the mini-laparotomies by measuring inflammatory markers (cytokines) from blood samples taken before and after surgery. We believe that a reduced acute inflammatory response post surgery has benefits for the patient in both the short term with regards to improved recovery times to mobilisation and restoration of bowel function and the longer term with relation to rates of local recurrence of the tumour and overall prognosis. Primary outcome(s): 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.

DISEASE(S): Cancer: Colorectal

PROVIDER: 2424569 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Clinical studies have shown that IV administration of anesthetics, lidocaine and ketamine with their anti-inflammatory properties, modulates the acute immune response associated with surgical tissue injury, and in this manner they are able to reduce postoperative pain. Lidocaine has anti-inflammatory effects on polymorphonuclear granulocytes, IL-6 and IL-8 cytokines, complement component C3a and IL-1ra in serum. Ketamine produces its anti-inflammatory effects by reducing CRP and IL-6 in serum and by inhibiting NF-kB, which regulates gene transcription responsible for the production of proinflammatory factors. Perioperative combinend IV administration of lidocaine and ketamine could have a more favorable anti-inflammatory effect compared to anesthetic given alone or with placebo. To investigate the effects of lidocaine and ketamine in patients undergoing abdominal surgery on: acute immune response following the level of proinflammatory factors in serum (CRP, IL-6, IL-8); postoperative pain management; recovery of bowel function; administration of opioids; reduction of total treatment costs; length of hospital stay (LOHS) A double-blind, placebo-controlled study will include 100 patients undergoing open colorectal surgery. Patients will be randomly assigned to one of four groups: lidocaine, ketamine, lidocaine-ketamine, and placebo. Lidocaine will be administered at a dose of 1.5 mg/kg prior to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of surgery. Ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery. Bolus and continuous placebo infusion (0.9% NaCl) will be equally administered at the same dose as the aforementioned anesthetics until the end of the surgery. Proinflammatory markers in serum (CRP, IL-6, IL-8) will be measured before induction of anesthesia, then 12 hours and 36 hours following the completion of surgery. The intensity of pain will be measured using the VAS score 2 hours and 4 hours following surgery and every 12 hours the following days. The investigators will measure also the consumption of opioids during and after surgery, the length of stay in the ICU, where pain control and analgesics use will be measured, as well as recovery of bowel function.

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Evaluation of the inflammatory response to minilaparotomy compared to conventional laparotomy in the surgical resection of colorectal cancer including its influence on long term survival and local recurrence

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