...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Trials >A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) – the UNBLOCS trial: a study protocol for a randomised controlled trial
【24h】

A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) – the UNBLOCS trial: a study protocol for a randomised controlled trial

机译：在国家卫生局（NHS）中确定to激光经尿道前列腺电切术（ThuVARP）与经尿道前列腺电切术（TURP）的临床和成本效益的随机对照试验– UNBLOCS试验：一项随机研究方案对照试验

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background Transurethral resection of the prostate (TURP) has been the standard operation for benign prostatic obstruction (BPO) for 40?years, with approximately 25,000 procedures performed annually, and has remained largely unchanged. It is generally a successful operation, but has well-documented risks for the patient. Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a surgical technique similar to TURP. The small amount of study data currently available suggests that ThuVARP may have certain advantages over TURP, including reduced blood loss and shorter hospital stay, earlier return to normal activities, and shorter duration of catheterisation. Design A multicentre, pragmatic, randomised, controlled, parallel-group trial of ThuVARP versus standard TURP in men with BPO. Four hundred and ten men suitable for prostate surgery were randomised to receive either ThuVARP or TURP at four university teaching hospitals, and three district general hospitals. The key aim of the trial is to determine whether ThuVARP is equivalent to TURP judged on both the patient-reported International Prostate Symptom Score (IPSS) and the maximum urine flow rate (Qmax) at 12?months post-surgery. Discussion The general population has an increased life expectancy. As men get older their prostates enlarge, potentially causing BPO, which often requires surgery. Therefore, as the population ages, more prostate operations are needed to relieve obstruction. There is hence sustained interest in the condition and increasing need to find safer techniques than TURP. Various laser techniques have become available but none are widely used in the NHS because of lengthy training required for surgeons or inferior performance on clinical outcomes. Promising initial evidence from one RCT shows that ThuVARP has equivalent clinical effectiveness when compared to TURP, as well as other potential advantages. As ThuVARP uses a technique similar to that used in TURP, the learning curve is short, potentially making it also very quickly generalisable. This randomised study is designed to provide the high-quality evidence, in an NHS setting, with a range of patient-reported, clinical and cost-effectiveness outcomes, which will underpin and inform future NICE guidance. Trial registration ISRCTN registry, ISRCTN00788389 . Registered on 20 September 2013.
机译：背景技术经尿道前列腺前列腺切除术（TURP）一直是良性前列腺梗阻（BPO）的标准手术已有40多年历史，每年约进行25,000例手术，并且基本上没有变化。通常这是一项成功的手术，但对患者有充分记录的风险。使用类似于TURP的手术技术，前列腺激光经尿道汽化术（ThuVARP）蒸发并切除前列腺。目前可获得的少量研究数据表明，ThuVARP可能比TURP具有某些优势，包括减少失血量和缩短住院时间，更早恢复正常活动以及缩短导管插入时间。设计ThuVARP与标准TURP在BPO男性中进行的多中心，实用，随机，对照，平行分组试验。在四所大学教学医院和三所地区综合医院中，四百一十名适合前列腺手术的男性被随机分配接受ThuVARP或TURP。该试验的主要目的是确定ThuVARP是否等同于根据患者报告的国际前列腺症状评分（IPSS）和术后12个月最大尿流率（Qmax）判断的TURP。讨论普通人群的预期寿命增加。随着男性年龄的增长，其前列腺增大，可能导致BPO，这通常需要进行手术。因此，随着人口的老龄化，需要更多的前列腺手术来减轻阻塞。因此，人们对该病持续存在兴趣，并且越来越需要找到比TURP更安全的技术。各种激光技术已经可用，但由于外科医师需要长期的培训或临床效果较差，因此没有在NHS中广泛使用。一项RCT的有前途的初步证据表明，与TURP相比，ThuVARP具有同等的临床有效性，并具有其他潜在优势。由于ThuVARP使用的技术与TURP中使用的技术类似，因此学习曲线很短，因此有可能很快将其推广。这项随机研究旨在在NHS环境中提供高质量的证据，以及一系列患者报告的临床和成本效益结果，这些结果将为NICE的未来指导奠定基础并提供参考。试用注册ISRCTN注册中心ISRCTN00788389。 2013年9月20日注册。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号