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Evaluation of postoperative bleeding control employing Surgicel: a clinical trial
Amjadi M, Hemmati-Ghavshough M, DadashKarimi H, Mohammad-Rahimi M
American journal of clinical and experimental urology. 2023;11(2):177-184
Abstract
INTRODUCTION Various techniques have been developed for the rapid control of bleeding as a potential surgical complication. Research shows that the Surgicel has a significant effect on reducing bleeding in most surgeries; however, in our experimental observations on patients undergoing open prostatectomy, not only no significant reduction was seen in the amount of bleeding, but in some cases, Surgicel led to infection. Therefore, in this study, the effect of the Surgicel on infection and bleeding in open prostatectomy was investigated. MATERIALS AND METHODS Thirty patients undergoing open prostatectomy were randomly divided into two groups. To control bleeding after suturing the bladder neck, the Surgicel was installed in the first group, while it was not in the second group. Hemoglobin, hematocrit, PT, PTT, INR, bleeding rate, and postoperative complications were evaluated in all patients. RESULTS In the studied groups, hemoglobin level and hematocrit percentage before surgery and on the first and second days after surgery, along with coagulation status, were compared in terms of PT, PTT, and INR. There were no significant differences between the studied variables and baseline variables. CONCLUSION The present study revealed that the Surgicel in open prostatectomy was ineffective in controlling bleeding and can lead to infection.
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2.
Effect of Perioperative Tranexamic Acid on Blood Loss following Open Simple Prostatectomy: A Prospective Review in Nigerian Men
Onyeze, C. I., Badmus, T. A., Salako, A. A., Owojuyigbe, A. M., Jeje, E. A., Olasehinde, O. O., Adeyemo, A., David, R. A.
West African journal of medicine. 2023;40(9):909-913
Abstract
BACKGROUND Haemorrhage is a common complication following open simple prostatectomy and patients may sometimes require a blood transfusion. Tranexamic acid has been shown to reduce blood loss following transurethral resection of the prostate and open radical prostatectomy. This study evaluated the effect of perioperative intravenous administration of tranexamic acid on blood loss and blood transfusion rates in patients who had OSP for benign prostatic enlargement. METHODOLOGY This was a comparative study of patients with documented prostate glands 60g and above scheduled for OSP. Initial hematocrit was done a day before surgery. The patients were randomized into a tranexamic acid group, which received perioperative intravenous tranexamic acid and the no-TXA group which received placebo (0.9% saline). All patients had open simple retropubic prostatectomy. Final post-operative hematocrit was assessed 72 hours after surgery, and blood loss was calculated using the modified Gross formula (actual blood loss = estimated blood volume x change in hematocrit / mean hematocrit). The transfusion rate was documented. RESULTS Fifty-six patients participated in this study and were randomized into a tranexamic acid group and no-tranexamic acid group. The mean age of patients in the tranexamic acid group was 66.07 ±7.08 years and was comparable to the no- tranexamic acid group which was 66.50 ± 8.80 years (P = 0.842). The median total blood loss was lower in the tranexamic acid group (502mls, IQR 613) compared to the no-tranexamic acid group (801mls, IQR 1069). The difference in the median blood loss between the two groups was 299mls (U 275, P 0.055). The rate of blood transfusion was lower in the tranexamic acid group (6 patients, 21%) compared to the no tranexamic acid group (11 patients, 39%), (P = 0.146). There was no difference in complication rates between the two groups. CONCLUSION The use of tranexamic acid in patients undergoing open simple prostatectomy showed a trend towards reduced intraoperative blood loss and less need no tranexamic for blood transfusion. This is of clinical significance, especially in elderly patients with low cardiovascular reserve.
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3.
The effect of tranexamic acid on perioperative blood loss in transurethral resection of the prostate: A double-blind, randomized controlled trial
Vanderbruggen, W., Brits, T., Tilborghs, S., Derickx, K., De Wachter, S.
The Prostate. 2023
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Editor's Choice
Abstract
BACKGROUND Bleeding and bleeding-related complications remain common after bipolar transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. This may possibly lead to prolonged postoperative irrigation, catheterization, and hospital stay. The objective of this trial was to evaluate the effect of high-dose tranexamic acid (TXA) on perioperative blood loss in patients treated with bipolar TURP for prostate sizes between 30 and 80 g. METHODS We conducted a single-center, prospective, double-blind, randomized controlled trial. Eighty patients were screened for inclusion between March 2020 and January 2023. After exclusion, 65 patients were randomized in two comparable groups. The TXA group (31 patients) received a TXA intravenous loading dose of 10 mg/kg over 30 min before induction, followed by a maintenance dose of 5 mg/kg/h over 12 h. The placebo group (34 patients) received an equal dose of saline infusion. We measured age, weight, preoperative prostate size, anticoagulant use, 5-alpha reductase inhibitor use, preoperative urinary tract infection, American Society of Anesthesiologists score, difference in pre- and 24 h postoperative hemoglobin and hematocrit levels, operative time, resected adenoma weight, duration of postoperative irrigation, total amount of postoperative irrigation fluid, indwelling catheter time, duration of hospital stay, blood transfusion rate, and 4-week complication rate. RESULTS Baseline characteristics in both groups were comparable. Postoperative hemoglobin decrease in TXA versus placebo group was 1 versus 1.6 mg/dL, respectively (p = 0.04). In addition, the amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups. CONCLUSIONS Perioperative high-dose TXA seems beneficial in reducing hemoglobin loss, postoperative irrigation, catheterization time, and hospital stay in bipolar TURP for prostate sizes between 30 and 80 g, without increased risk of TXA-related thromboembolic events.
PICO Summary
Population
Patients treated with bipolar transurethral resection of the prostate (n= 65).
Intervention
Tranexamic acid (TXA), (n= 31).
Comparison
Placebo (saline infusion), (n= 34).
Outcome
Postoperative haemoglobin decrease in TXA compared to placebo was 1 versus 1.6 mg/dL, respectively. The amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups.
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4.
Evaluating the effectiveness of tranexamic acid administration in reducing bleeding in benign prostate hyperplasia patients underwent open prostatectomy: A double-blind randomized clinical trial
Mohammadi Sichani M, Mohammadi S, Khorrami MH, Zargham M, Javid A, Dehghani M, Gholipour F, Dehkordi PR, Kazemi R
Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences. 2023;28:8
Abstract
BACKGROUND Blood loss of postoperative after prostate surgery could be related with an increase in urinary fibrinolytic activity. Tranexamic acid (TXA) is both a potent inhibitor of plasminogen and urokinase activators and a low molecular weight substance that is excreted unchanged in the urinary tract and can be administered both orally and intravenously. This study aimed to evaluate the effectiveness TXA administration in reducing bleeding in benign prostatic hyperplasia (BPH) patients who underwent open prostatectomy. MATERIALS AND METHODS This double-blind randomized clinical trial was conducted on patients with BPH who underwent open prostatectomy. The first group received TXA (1 gr IV from during surgery to 48 h after surgery, 3 times/day). Twenty-four hours after surgery, the two groups were compared in terms of bleeding rate. Hemoglobin (Hb), hematocrit (HCT), and platelet (Plt) counts were also assessed before and after the intervention. RESULTS Intervention and control groups were comparable in terms of basic and baseline values of variables at the beginning of the study (P > 0.05). The mean bleeding volume in TXA group was significantly lower than the control group 112.11 ± 53.5 and 190.00 ± 97.5 CC; P ≤ 0.001). Mean hospitalization (3.28±0.46 vs. 4.38 ± 0.95 days P < 0.001) and surgery duration (98.11 ± 37.11 vs. 128.00 ± 39.12 h; P = 0.001) were significantly lower in TXA group compared to control intervention. CONCLUSION According to the findings of the current study, the administration of TXA led to reduce bleeding in BPH patients who underwent open prostatectomy. Furthermore, the mean Hb, HCT, levels were significantly affected by TXA. TXA treatment approach also can reduce the surgery and hospitalization time effectively. TXA approach is recommended as effective procedure in BPH patients who underwent open prostatectomy.
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Evaluation of the efficacy of oxidized cellulose (surgicel) in reducing blood loss in suprapubic simple open prostatectomy: A randomized clinical trial
Kazemi R, Gholipour F, Salehi H, Sichani MM, Behnamfar A, Fathi M
Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences. 2023;28:29
Abstract
BACKGROUND Simple open prostatectomy is still the treatment of choice for removing large prostates; however, peri-surgical bleeding accompanied by this technique has always been a challenge for urologist surgeons. Therefore, the present study aimed to investigate the effect of surgicel on reducing bleeding in trans-vesical prostatectomy. MATERIALS AND METHODS The present double-blinded clinical trial included 54 patients with Benign Prostatic Hyperplasia (BPH), divided into two groups of 27, and underwent trans-vesical prostatectomy. After removing the prostate, the prostate adenoma was weighed in the first group. Then, two surgicel were inserted into the prostate loge for prostate adenomas weighing 75 g or less. For larger prostates, another surgicel was inserted for each 25 g weight higher than the limit of 75 g. However, no Surgicel was inserted in the control group. Other steps of the procedure were the same in both groups. Moreover, hemoglobin and hematocrit levels were assessed in both groups; preoperation, intra-operative, 24 h, and 48 h postoperative. In addition, all the fluid used for bladder irrigation was collected, and its hemoglobin level was assessed. RESULTS According to our results, no intergroup difference in hemoglobin level changes, hematocrit changes, International Prostate Symptom Score (IPSS), postoperative hospital stay, and number of packed cells received. However, the postoperative blood loss in bladder lavage fluid was significantly higher in the control group (120.83 ± 46.66 g) as compared to the surgicel group (72.56 ± 32.53 g) (P < 0.001). CONCLUSION The present study concluded that using surgicel in trans-vesical prostatectomy could reduce postoperative bleeding without increasing the chance of postoperative complications.
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Effects of omega-3 fatty acids supplementation on perioperative blood loss and complications after radical prostatectomy
Fradet, S., Pelletier, J. F., Singbo, N., Lacombe, L., Toren, P., Lodde, M., Dujardin, T., Tiguert, R., Fradet, Y., Robitaille, K., et al
Clinical Nutrition Espen. 2022;47:221-226
Abstract
BACKGROUND AND AIMS Many dietary supplements, including omega-3 fatty acids (ω3), are suspected to affect blood coagulation and platelet function. Despite no clinical evidence, discontinuation is recommended before radical prostatectomy. However, long-chain ω3 (LCω3) appear beneficial against prostate cancer progression. Here, we aim to determine the effect of LCω3 supplements on perioperative bleeding, hemoglobin, platelets, and postoperative complications after radical prostatectomy. METHODS This is a planned exploratory analysis of 130 patients diagnosed with prostate cancer grade group 2 or greater enrolled in a randomized controlled trial (NCT02333435) testing the effects of LCω3, on prostate cancer biological and pathological outcomes at radical prostatectomy as main outcomes. The LCω3 intervention (MAG-EPA 3 g daily) or equivalent placebo was given 4-10 weeks prior to radical prostatectomy. An intention-to-treat analysis approach was used with bi-variate statistical testing of bleeding and complications outcomes. We also estimated the difference between groups using linear regression and non-parametric quantile regression models. All models were adjusted for confounding variables selected on clinical relevance. RESULTS We found no clinically significant effect of LCω3 versus placebo on perioperative bleeding, laboratory tests or postoperative complications. In contrast, as expected, we found a significant increase in perioperative bleeding in open retropubic radical prostatectomy compared to robot-assisted radical prostatectomy (adjusted difference 115.8 mL, p = 0.04). CONCLUSIONS Our results suggest that ω3 supplements can be safely taken before radical prostatectomy without increasing surgical bleeding risk. These findings are relevant since ω3 may beneficially affect prostate cancer evolution.
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Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate (HoLEP): A Prospective Randomized, Controlled Trial
Assmus MA, Lee MS, Helon JW, Krambeck A
Journal of endourology. 2022
Abstract
INTRODUCTION Tranexamic acid (TXA) is a clot promoting agent utilized during orthopedic procedures to decrease bleeding. Urologists have demonstrated benefits of TXA in percutaneous surgery. Our objective was to assess safety and efficacy of single-dose TXA on same-day HoLEP outcomes. METHODS From September 2021 to January 2022, we prospectively randomized 110 patients undergoing HoLEP to either 1 gram of TXA after induction or no treatment. IRB approval (STU00215134) and registry with ClinicalTrials.gov (NCT05082142) was obtained prior to enrollment. Primary outcome was rate of successful same day discharge (SDD). Secondary outcomes included transfusion rate, same day catheter removal, length of stay (LOS), and 90-day complications. Power analysis determined 110 patients should be enrolled to detect a 25% difference in SDD rate. RESULTS There was no difference in patient demographic and prostate features between control (n=55) and TXA groups (n=55) (all p>0.05). The overall rate of successful SDD was not different between control and TXA groups (49/55 (89%) vs. 51/55 (93%), p=0.74). Median LOS (hh:mm) was not different between groups (03:07 vs. 02:50, p=0.23) with only 3/110 (2.7%) having a LOS >24hours. Successful same day catheter removal occurred in 99/110 (90%) patients with no difference between groups (49/55 vs. 50/55, p=0.99). There was no difference in operative parameters (time, energy, specimen weight) and postoperative complications between groups (all p>0.05). No patients required transfusions and there were no major 90-day complications related to surgery (Clavien-dindo ≥IIIb). CONCLUSION TXA administration is safe but did not impact same day discharge after HoLEP.
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Dorsal Dartos Flap Prepared Before Urethroplasty, Less Bleeding of Operation: A New Perspective on Hypospadias
Issi Y, Bilir C
Turkish journal of urology. 2022;48(2):150-154
Abstract
BACKGROUND The benefits of preparing the dorsal dartos flap before urethroplasty were investigated. MATERIALS AND METHODS Patients with coronal, subcoronal, and distal penile hypopadias without severe cordee who underwent surgical repair between October 2016 and September 2020 were included in the study. Tubularized incised plate urethroplasty technique was applied to all patients. The patients were divided into two groups: In Group 1, the dorsal dartos flap was prepared after urethroplasty, which is the commonly used technique today, and sutured on the neourethra. In Group 2, the dorsal dartos flap was prepared before the post-degloving urethroplasty. The amount of bleeding, the duration of the surgery, and the complications between the two groups were recorded and compared. RESULTS Twenty-two patients who could be followed up for at least 3 months were examined. There were 10 patients in Group 1 and 12 patients in Group 2. A statistically significant difference was found between the amount of bleeding of the operation in the two groups. Duration of operation, hematoma, infection, skin necrosis, or glanular dehiscence were not observed in any patient. CONCLUSIONS Preparing the dorsal dartos flap, before urethroplasty significantly reduces the amount of bleeding. This may be a new modification alternative in hypospadias surgery.
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Can tranexamic acid in irrigation fluid reduce blood loss during monopolar transurethral resection of the prostate? A randomised controlled trial
Tawfick A, Mousa W, El-Zhary AF, Saafan AM
Arab journal of urology. 2022;20(2):94-99
Abstract
OBJECTIVE To assess the efficacity and safety of using tranexamic acid (TXA) in the irrigation solution during transurethral resection of the prostate (TURP). PATIENTS AND METHODS A total of 50 patients undergoing TURP for benign prostatic hyperplasia were prospectively randomised in a controlled clinical trial and distributed into two groups. Group A received 0.1% TXA 1000 mg (10 mL) in 1 L of irrigation solution of sterile wash (glycine) during surgery, while Group B received 10 mL distilled water (placebo) in 1 L of irrigation solution of sterile wash (glycine) during surgery. At the end of surgery, a three-way catheter was inserted in the bladder. Group A received local 500 mg of TXA (5 mL), which was dissolved in 100 mL of normal saline solution, while Group B received distilled water (5 mL) dissolved in 100 mL of normal saline solution after which the catheter was clamped. The serum haemoglobin (Hb) concentration, haematocrit (HCT), blood loss volume, Hb concentration in the irrigation fluid, and bladder irrigation volumes were compared between the two groups at three time-points: preoperatively and at 4- and 24-h postoperatively. Coagulation function, complications, thromboembolic events, quality of endoscopic view, surgery duration, and hospital stay were also noted. RESULTS Group A had significantly lower blood loss intraoperatively, and at 4- and 24-h postoperatively compared to the control group (P < 0.05). The serum Hb concentration, HCT, Hb concentration in the irrigation fluid, and bladder irrigation volumes were significantly lower in the TXA group vs the control group (P < 0.001). The shortening of the surgery duration and improvement in the quality of the endoscopic view were significantly noted in the TXA group (P = 0.001). However, no thromboembolic events occurred in either group. CONCLUSION The use of TXA in the irrigation fluid during TURP and injection into the bladder postoperatively can reduce blood loss and the need for blood transfusion without increasing the risk of thrombosis.
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Can high-dose tranexamic acid have a role during transurethral resection of the prostate in large prostates? A randomised controlled trial
Samir M, Saafan AM, Afifi RM, Tawfick A
Arab journal of urology. 2022;20(1):24-29
Abstract
OBJECTIVES To assess the efficacy and safety of high-dose tranexamic acid (TXA) during bipolar transurethral resection of the prostate (B-TURP) in patients with large prostates compared to placebo. PATIENTS AND METHODS From February 2018 to May 2020, 204 patients with enlarged prostates of 80-130 g and in need of surgical intervention were randomised into two groups. Patients in Group A underwent B-TURP and received TXA as an intravenous loading dose of 50 mg/kg over 20 min before induction of anaesthesia followed by a maintenance infusion of 5 mg/kg/h until resection was completed. The patients in Group B (placebo) received a saline infusion of a similar volume. RESULTS There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group (P < 0.001). However, there was no significant difference in the blood transfusion rate between the two groups with five patients (5.5%) in the placebo group and four (4.2%) in the TXA group requiring a transfusion (P = 0.74). The procedural time was significantly less in the TXA group vs the control group, at a mean (SD) of 79.93 (22.18) vs 90.91 (21.4) min (P = 0.001). Also, the intraoperative irrigation fluid volume and postoperative irrigation duration were significantly less in the TXA group vs the control group, at a mean (SD) of 19.21 (3.13) vs 23.05 (3.8) L and 14.75 (5.15) vs 18.33 (5.96) h, respectively (P = 0.001). Catheterisation and hospital stay durations were comparable between both groups (P = 0.384 and P = 0.388, respectively). No complications were recorded with use of high-dose TXA. CONCLUSION High-dose TXA was effective in controlling blood loss during B-TURP in patients with large prostates, with no adverse drug reactions.