Could Transurethral Resection of the Prostate Using the TURis System Take Over Conventional Monopolar Transurethral Resection of the Prostate? A Randomized Controlled Trial and Midterm Results
Could Transurethral Resection of the Prostate Using the TURis System Take Over Conventional Monopolar Transurethral Resection of the Prostate? A Randomized Controlled Trial and Midterm Results
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DOI：
10.1016/j.urology.2014.04.025
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发表时间：
2014-08-01
期刊：
影响因子：
2.1
通讯作者：
Azuma, Haruhito
中科院分区：
文献类型：
--
作者：
Komura, Kazumasa;Inamoto, Teruo;Azuma, Haruhito
目的评估是否双极经尿道前列腺切除术使用TURIS（奥林巴斯，东京，日本）系统表现出可比的疗效和安全性报告36个月的后续followings.METHODS该试验在大学医院医学信息网络临床试验注册在日本（试验编号UMIN 000010801）。患者被随机选择接受经尿道前列腺切除术使用TURis或传统的单极技术。主要终点是根据手术时间、钠和血红蛋白水平下降、血凝块保留和导管插入时间确定的安全性。次要终点是随访36个月后患者的疗效结果。TURis组的平均手术时间显著延长（单极和TURis组分别为68.4和79.5分钟; P = 0.048）。两组之间血红蛋白、红细胞压积和围手术期输血率的下降无显著差异，而单极组治疗后血凝块潴留（2级）似乎更常发生（单极组62例中7例[12.3%] vs TURis组63例中1例[1/8%]; P = 0.061）。两组均无一例出现症状性经尿道电切综合征。结论TURis系统首次证实了治疗后36个月的持续有效性，这似乎也是更可取的，因为它们产生了更有利的临床结局。然而，TURis系统需要明显更多的切除时间，这可能不完全是治疗良性前列腺梗阻的灵丹妙药，特别是对于前列腺体积较大的患者。(C)2014 Elsevier Inc.
OBJECTIVE To assess whether bipolar transurethral resection of the prostate using the TURis (Olympus, Tokyo, Japan) system demonstrates comparable efficacy and safety reporting 36 months of follow-up findings.METHODS The trial was registered at University hospital Medical Information Network Clinical Trials Registry in Japan (trial number UMIN 000010801). Patients were randomly selected to undergo transurethral resection of the prostate using either the TURis or the conventional monopolar technique. Primary end points were safety according to operation time, decline of sodium and hemoglobin levels, clot retention, and catheterization time. Secondary end points were efficacy findings for patients after 36 months of follow-up.RESULTS A total of 136 patients were enrolled. Mean operation times were significantly prolonged in the TURis group (68.4 and 79.5 minutes for monopolar and TURis groups, respectively; P = .048). No significant differences in the decline of hemoglobin, hematocrit, and perioperative transfusion rates between groups were seen, whereas clot retention (grade 2) after the treatment seemed to occur more often in the monopolar group (7 of 62 [12.3%] in monopolar group vs 1 of 63 [1/8%] in TURis group; P = .061). No case presented symptomatic transurethral resection syndrome in either groups.CONCLUSION Continued efficacy at 36 months after the treatment could be confirmed for the first time in TURis system, which also seems to be preferable as they produced more clinically favorable outcomes. Nevertheless, the TURis system required significantly more resection time, which might not entirely be a panacea for the treatment of benign prostatic obstruction, especially for patients having larger prostatic volumes. (C) 2014 Elsevier Inc.