Can the prophylactic administration of tranexamic acid reduce the blood loss after robotic assisted radical prostatectomy? RARPEX (Robotic Assisted Radical Prostatectomy with TranEXamic acid): study protocol for a randomized controlled trial (SPIRIT Compliant)

2021 ◽  
Author(s):  
Michal Balik ◽  
Josef Kosina ◽  
Petr Husek ◽  
Jaroslav Pacovsky ◽  
Milos Brodak ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Postoperative Blood Loss ◽  
Double Blind ◽  
Robotic Assisted ◽  
Prophylactic Administration ◽  
End Point ◽  
Perioperative Bleeding ◽  
Robotic Assisted Radical Prostatectomy

Abstract BackgroundThe prophylactic administration of tranexamic acid reduces the blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirmed this finding. The aim of this prospective, double-blind, randomized study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and on the incidence and severity of complications.Methods / DesignBased on the results of our pilot study, we decided to conduct this prospective, double-blind, randomized trial to confirm preliminary data. The primary end-point is to analyze the effect of tranexamic acid on perioperative and postoperative blood loss (decrease in hemoglobin levels) in robotic-assisted radical prostatectomy. The secondary end-point is to analyze the effect of tranexamic acid on postoperative complications. Additional end-point is to confirm the safety of tranexamic acid in robotic assisted radical prostatectomy.DiscussionNo study to date has tested the prophylactic administration of tranexamic acid in the beginning of robotic assisted radical prostatectomy. This study is designed to answer the question whether it might lower the blood loss after the procedure or increase the rate and severity of complications.Trial registrationThe trial was prospectively registered under title "Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? (RARPEX)" on 25th March 2020 at ClinicalTrials.gov with the registration number NCT04319614.

scholarly journals Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study

2020 ◽  
Vol 63 (4) ◽  
pp. 176-182
Author(s):  
Michal Balík ◽  
Josef Košina ◽  
Petr Hušek ◽  
Miloš Broďák ◽  
Filip Čečka
Keyword(s):  
Radical Prostatectomy ◽  
Tranexamic Acid ◽  
Randomized Study ◽  
Double Blind ◽  
Robotic Assisted ◽  
Dorsal Vein ◽  
Perioperative Bleeding ◽  
Robotic Assisted Radical Prostatectomy ◽  
And Control

Background: The prophylactic administration of tranexamic acid has been shown to be appropriate for procedures with a high risk of perioperative bleeding in cardiac surgery and orthopaedics. In urology the ambiguous results have been reported. Our goal was to evaluate the effect of tranexamic acid administration in robotic-assisted radical prostatectomy (RARP). A pilot, prospective, double-blind, randomized study was conducted to evaluate this effect. Methods: The study included 100 patients who received RARP in the period from April 2017 to January 2018. The patients were randomly assigned to study and control groups of 50 patients each. Results: The median follow-up was 6 months. Lower haemoglobin level drop weighted for gram of operated prostate was observed in the study group when treating the dorsal vein complex (DVC) at the beginning of the procedure (p = 0.004 after 3 hours and p < 0.001 after 24 hours). There was no evidence of any serious side effect of tranexamic acid. Conclusion: We demonstrated the safety of tranexamic acid at RARP. In addition, we showed that administration of tranexamic acid at the beginning of RARP significantly reduces the decrease in haemoglobin after the procedure when treating the DVC at the beginning of the procedure.

A feasible and time-efficient adaption of the neurosafe intraoperative frozen section technique to robotic-assisted radical prostatectomy.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 147-147
Author(s):  
Burkhard Beyer ◽  
Pierre Tennstedt ◽  
Katharina Boehm ◽  
Jonas Schiffmann ◽  
Thorsten Schlomm ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Blood Loss ◽  
Frozen Section ◽  
Oncological Outcome ◽  
Nerve Sparing ◽  
Frozen Sections ◽  
Robotic Assisted ◽  
Significant Difference ◽  
Robotic Assisted Radical Prostatectomy ◽  
Patient Side

147 Background: In robotic-assisted radical prostatectomy (RARP) intraoperative frozen sections are often avoided due to suspected difficulties in harvesting the prostate during this procedure, loss in pneumoperitoneum, increased blood loss and lacking impact on functional outcome. We demonstrate the technique, feasibility and beneficial impact of our NeuroSAFE technique on the rate of nerve-sparing (NS) in RARP and analyse the oncological outcome. Methods: We analyzed 1,570 consecutive patients undergoing RARP from 2004 to 2012. NeuroSAFE was done in 1,178 pts. We compared OR-time, blood loss, frequency of nerve-sparing (NS) and PSM in non-NeuroSAFE versus NeuroSAFE-RARP. The prostate was intraoperatively harvested via an extension of the camera trocar incision without undocking the system. Instrument arms were not undocked. Blood spillage from the dorsal vein complex due to loss of pneumoperitoneum was avoided by upward traction on the transurethral catheter. After prostate removal, pneumoperitoneum was reestablished by closing the extended incision and repositioning of the optical trocar. NeuroSAFE-procedure consisted of intraoperative bilateral frozen sections covering the entire contact area of the prostate and the neurovascular bundles. Results: There was no significant difference in blood loss (253.5±204.4 ml vs. 265.8±246.7 ml, p=0.49) and OR-time. (220 min ± 51 vs. 224 min ± 64, p=0.22). No complications associated with specimen harvesting occurred. NS-rate increased significantly with vs. without NeuroSAFE (overall 97% vs. 81%, pT2 99% vs. 90%, pT3a 94% vs. 74%, pT3b 91% vs. 30). PSM rate dropped significantly with NeuroSAFE (overall 16% vs. 24%, pT2 8% vs. 15%, pT3a 22% vs. 39%, pT3b 49% vs. 67%, all p<0.05). Conclusions: We demonstrate a time-efficient adaption of the NeuroSAFE without patient side cart undocking, easy harvesting process, no increased blood loss or OR-time increased rate of nerve-sparing frequency and reduction of PSMs.

Postoperative administration of tranexamic acid as approach to reduce blood loss after open-heart surgery

2020 ◽  
Vol 76 (1) ◽  
pp. 43-49
Author(s):  
Florian Meissner ◽  
Katrin Plötze ◽  
Klaus Matschke ◽  
Thomas Waldow
Keyword(s):  
Blood Loss ◽  
Tranexamic Acid ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Postoperative Blood Loss ◽  
Open Heart ◽  
Reduce Blood Loss ◽  
Perioperative Bleeding ◽  
Increased Risk ◽  
Postoperative Administration

BACKGROUND: Tranexamic acid (TXA) reduces perioperative bleeding among patients undergoing heart surgery. It is uncertain whether its postoperative administration, after prior administration before cardiopulmonary bypass (CPB), has an additional benefit. OBJECTIVE: Our study aimed to evaluate whether the postoperative administration of TXA reduces the blood loss after heart surgery. METHODS: In a retrospective cohort study at the University Heart Center Dresden, patients who underwent on-pump open-heart surgery and received 1 g TXA before CPB were included. Patients with postoperative administration of 1 g TXA were compared to patients without. Primary endpoint was the postoperative blood loss within 24 hours. RESULTS: Among 2,179 patients undergoing heart surgery between 1 July 2013 and 31 October 2014, 92 (4.2%) received TXA postoperatively. After matching, 71 patients with postoperative administration of TXA were compared to 71 without (n = 142). Postoperative administration of TXA did not result in decreased blood loss (MD 146.7 mL; p = 0.064). There was no evidence of an increased risk for thromboembolic complications. CONCLUSIONS: The postoperative administration of TXA did not reduce blood loss. The use of TXA was shown to be safe in terms of thromboembolic events and hospital mortality. Unless there is no clear evidence, the postoperative administration of TXA should be restricted to patients with massive blood loss and signs of hyperfibrinolysis only.

Training of robotic-assisted radical prostatectomy, experiences of 100 cases

2018 ◽  
Vol 8 (4) ◽  
Author(s):  
Le Chuyen Vu ◽  
Keyword(s):  
Radical Prostatectomy ◽  
Blood Loss ◽  
Learning Curve ◽  
Nerve Sparing ◽  
Second Phase ◽  
Robotic Assisted ◽  
Estimated Blood Loss ◽  
Robotic Assisted Radical Prostatectomy ◽  
Surgical Duration ◽  
Surgery Duration

Abstract Introduction: The application of robotics in endoscopic techniques becomes commonly in Vietnam. The transition from conventional surgery and laparoscopy to robotic-assisted endoscopy has its own difficulties and advantages. We summarize the experiences of training this procedure through 100 prostate cancers treated by robotic-assisted laparoscopic surgery in the Urology Department, Binh Dan Hospital, from December 2016 to June 2018. Material and Methods: This was a clinical comparative and vertical study. 100 patients diagnosed prostate cancer, staged T1 to T3 were performed robotic-assisted radical prostatectomy (RARP), with or without nerve sparing and local pelvic lymph nodes dissection. The comparison of 5 groups of surgeons, two phases with 50 cases each was conducted. Research variables: Stages of cancer, pre and postoperative PSA levels, Gleason score, lymph node metastases, estimated blood loss, surgery duration, urinary incontinence, hospitalization stay and complications are enrolled . Results: Five surgeons A, B, C, D, E had 38,22,18,14 and 6 cases respectively. The mean age, PSA and cancer stage were statistically similar (p> 0,3). The surgery duration were 176.81, 274.77, 231.88, 286.92 and 272.50 minutes, respectively, which was statistically different (p <0.01). Mean blood loss were 404.62, 476.64, 370, 244.62, 462.50 ml, which was statistically different (p <0.01). 15 cases needed blood transfusion. Hospitalization was 5.42, 11.14, 4.94, 6.31, 7 days, which was not statistically similar among groups (p <0.05), but had a statistically significant relationship with drainage duration and complication rate of each group (p <0.01). The second phase of the study significantly improved in surgery duration from 270 to 214.65 minutes compared to the first phase. Mean blood loss increased from 361.60 to 427.44 ml although the average PSA decreased from 42.84 to 35.72 ng/ml. Lymphadectomy in the first half was 22/50 and in the second half was 29/50. The learning curve of the operation duration reached after 20 cases, however there was little improvement afterwards. More members of surgical team had, more standard deviation of surgical duration was. Conclusion: By studying the training of robotic-assisted radical prostatectomy at Binh Dan Hospital we found that surgery could be safely with acceptable complications. Optimal learning curve for surgical duration was achieved at the first 20 cases. Training needed to have a procedure in place to replicate the number of surgeons without compromising the overall outcome.

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