A secondary

aim was to evaluate whether using a robot device in the laparoscopic prostatectomy influences the effect of different anesthetic techniques applied. Methods Patient population Between October 2009 and June 2012, 400 consecutive patients with primary prostate cancer, undergoing general anaesthesia and conventional laparoscopic radical prostatectomy (LRP) or robot-assisted laparoscopic prostatectomy (RALP), were considered eligible for the study (Figure 2). This study was approved by the Ethics XMU-MP-1 clinical trial Committee of the Regina Elena National Cancer Institute, Rome (Prot.CE/550), and a written informed patient consent was obtained from all participants. Protocol was registered in Clinical trials.gov (NCT01998685). The inclusion criteria for the study were a newly diagnosed cancer of the prostate with histological Gleason score evaluation. Exclusion criteria included: (a) ASA >2, (b) metabolic equivalent task < 4, (c) BMI > 30, (d) no pre-operative pharmacological thromboprophylaxis and/or anti-coagulant therapy, (e) history of abnormal bleeding, or abnormal coagulant factors, (f) sepsis within the last 2 weeks, (g) previous new adjuvant

treatments (chemo, hormone, and radiotherapy), (h) non-steroid, anti-inflammatory and statin drugs for at least 2 wks before surgery,

(i) venous or arterial nearly thromboembolism within the last 3 months, peripheral MK-8776 manufacturer venous disease, (l) neurological disease with extremity paresis, (m) chronic liver disease, (n) pre-operative haemoglobin concentration < 9 mg dl−1, (o) prolonged duration of MEK162 ic50 surgery (>3 hrs); (p) peri-operative blood transfusion, (q) inadequate material for laboratory testing. One exclusion criterion sufficed exclusion. Figure 2 Design of the study: patient selection. Out of the 400 patients with primary prostate cancer who underwent laparoscopic prostatectomy, 244 were excluded from the study for the following reasons: 218 for ASA ≥ 3, 4 for previous new adjuvant treatments, 22 for anti-inflammatory and statin therapy before surgery. Thus, 156 patients with primary prostate cancer constituted the patient population of this randomized study and were alternatively divided into 2 groups to receive TIVA-TCI or BAL anaesthesia prior to surgery. Then, a further 54 patients were excluded: 9 for a prolonged duration of surgery, 5 for intra-operative blood transfusion and 40 for inadequate blood samples. Finally, 102 patients with primary prostate cancer comprised the patient population of the study: 54 received TIVA-TCI and 48 BAL anesthesia prior to surgery.