Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial.

OBJECTIVES: To determine the efficacy of intraoperative treatment with low dose tranexamic acid in reducing the rate of perioperative transfusions in patients undergoing radical retropubic prostatectomy. DESIGN: Double blind, parallel group, randomised, placebo controlled trial. SETTING: One university hospital in Milan, Italy. PARTICIPANTS: 200 patients older than 18 years and undergoing radical retropubic prostatectomy agreed to participate in the trial. Exclusion criteria were atrial fibrillation, coronary artery disease treated with drug eluting stent, severe chronic renal failure, congenital or acquired thrombophilia, and known or suspected allergy to tranexamic acid. INTERVENTIONS: Intravenous infusion of tranexamic acid or equivalent volume of placebo (saline) according to the following protocol: loading dose of 500 mg tranexamic acid 20 minutes before surgery followed by continuous infusion of tranexamic acid at 250 mg/h during surgery. PRIMARY OUTCOME: number of patients receiving blood transfusions perioperatively. Secondary outcome: intraoperative blood loss. Six month follow-up to assess long term safety in terms of mortality and thromboembolic events. RESULTS: All patients completed treatment and none was lost to follow-up. Patients transfused were 34 (34%) in the tranexamic acid group and 55 (55%) in the control group (absolute reduction in transfusion rate 21% (95% CI 7% to 34%); relative risk of receiving transfusions for patients treated with tranexamic acid 0.62 (0.45 to 0.85); number needed to treat 5 (3 to 14); P = 0.004). At follow-up, no patients died and the occurrence of thromboembolic events did not differ between the two groups. CONCLUSIONS: Intraoperative treatment with low dose tranexamic acid is safe and effective in reducing the rate of perioperative blood transfusions in patients undergoing radical retropubic prostatectomy. Trial registration ClinicalTrials.gov identifier NCT00670345.

General versus spinal anesthesia with different forms of sedation in patients undergoing radical retropubic prostatectomy: results of a prospective, randomized study.

AIM: To assess the impact of spinal anesthesia (SpA) combined with three different forms of conscious sedation on intraoperative and postoperative outcome in patients undergoing radical retropubic prostatectomy (RRP) for organ confined prostate cancer (pCa). METHODS: A total of 121 consecutive patients with pCa undergoing RRP were randomized into four groups. They were randomized as follows: group 1 (general anesthesia: 34 patients), group 2 (lumbar 2 to lumbar 3 interspace SpA with diazepam as sedative agent: 28), group 3 (SpA with propofol: 30), and group 4 (SpA with midazolam: 29). Intraoperative and perioperative parameters were collected. RESULTS: The present study showed that muscle relaxation throughout RRP was not different in the four groups; bleeding was significantly (P = 0.04) lower with SpA, regardless of the form of sedation. Group 3 patients reported the best postoperative oxygen saturation percentage by pulse oximetry and sedation score (P = 0.02; d.f. = 3 and P < 0.0001; d.f. = 3, respectively), the shortest waiting time in the postoperative holding area (P < 0.001; d.f. = 3), the lowest pain on postoperative day 1 (P = 0.0004; d.f. = 3), and the highest frequency of first flatus passage (P = 0.0001; d.f. = 3). A higher number of group 4 patients were able to carry out unassisted ambulation (P < 0.0001; d.f. = 3). CONCLUSIONS: Conscious sedation coupled with SpA is a safe, reliable and effective procedure for patients undergoing RRP. The use of propofol as sedative agent offers several advantages both over other types of conscious sedation and general anesthesia.

Pfannenstiel versus vertical laparotomy in patients undergoing radical retropubic prostatectomy with spinal anesthesia: results of a prospective, randomized trial.

OBJECTIVE: To evaluate the impact of a standard vertical laparotomy versus a Pfannenstiel transverse laparotomy on intra-, peri-operative, and 6-month follow-up outcome in patients undergoing radical retropubic prostatectomy with pelvic lymphadenectomy with spinal anesthesia. METHODS: Between January 2003 and June 2003, 69 age-matched consecutive patients with clinically localized prostate cancer underwent radical retropubic prostatectomy with pelvic lymphadenectomy with spinal anesthesia and were randomized into Group 1 (vertical laparotomy: 35 patients) and Group 2 (Pfannenstiel laparotomy: 34 patients). An extensive analysis of the critical intra-, peri-operative, and 6-month follow-up clinical parameters was performed. RESULTS: Both the hemodynamics and the biochemical balance were not significantly different between the two groups. Overall blood loss (p = 0.78), autologous (p = 0.88) and homologous (p = 0.36) blood transfusions were similar regardless of the type of laparotomy. Surgical time was not significantly (p = 0.27) different between the two groups. Similarly, the two forms of laparotomy did not differ regarding the length of the surgical incision (p = 0.21), as measured at the end of the procedure. Post-operative oxygen saturation percentage by pulse oximetry, as well as post-op sedation score, were not significantly different (p = 0.06 and p = 0.97, respectively). Waiting time in the post-operative holding area (p = 0.15), and pain score in the post-operative holding area (p = 0.9) as well as on post-operative day 1 (p = 0.1) were not significantly different between the two groups. The rate of first flatus passage and of unassisted ambulation were similar regardless of the type of laparotomy during post-operative day day 1. The two types of incision made it possible to remove a similar (p = 0.34) number of pelvic lymph nodes and were associated to a similar rate of positive surgical margins among pT2 patients. At the 6-month follow-up the occurrence of a pelvic lymphocele and of deep venous thrombosis was similar in the two groups (p = 0.6 and p = 0.16, respectively). Complete urinary continence and spontaneous erectile function recovery was reported in a similar number of patients regardless of the type of surgical incision (p = 0.59 and p = 0.40, respectively). CONCLUSIONS: These results suggest that a Pfannenstiel transverse suprapubic laparotomy does not result in a significantly different outcome from a standard vertical laparotomy in patients undergoing a radical retropubic prostatectomy with pelvic lymphadenectomy with L2-L3 spinal anesthesia for clinically localized prostate cancer.

General versus spinal anesthesia in patients undergoing radical retropubic prostatectomy: results of a prospective, randomized study.

OBJECTIVES: To evaluate the impact of general anesthesia (GA) versus spinal anesthesia (SpA) on intraoperative and postoperative outcome in patients undergoing radical retropubic prostatectomy. METHODS: Seventy-two consecutive patients with clinically localized prostate cancer were randomized into group 1 (GA: 34 patients) or group 2 (L2-L3 or L3-L4 SpA: 38 patients) and underwent radical retropubic prostatectomy. The intraoperative and postoperative anesthetic and surgical variables were evaluated. RESULTS: The mean +/- SEM operative time was not significantly different between the two groups (P = 0.43). The overall blood loss was less in group 2 (P = 0.04). The mean +/- SEM postoperative time in the postoperative holding area was significantly shorter after SpA than after GA (P <0.0001). The perioperative pain outcome in the postoperative holding area was significantly better for group 2 than for group 1 (P = 0.0017), but postoperative pain on day 1 was not significantly different between the two groups. The postoperative sedation score was significantly less in group 2 than in group 1 (P <0.0001). On day 1, first flatus passed in a significantly larger number of patients in group 2 (P <0.0001), and the overall gait was greater for group 2 patients (P = 0.02). CONCLUSIONS: These results suggest that SpA allows good muscle relaxation and a successful surgical outcome in patients undergoing radical retropubic prostatectomy with pelvic lymphadenectomy for clinically localized prostate cancer. Moreover, SpA results in less intraoperative blood loss, less postoperative pain, and a faster postoperative recovery than GA.