Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Health Technol Assess. 2012;16(41):1-313. doi: 10.3310/hta16410.
Complete surgical removal of the prostate, radical prostatectomy, is the most frequently used treatment option for men with localised prostate cancer. The use of laparoscopic (keyhole) and robot-assisted surgery has improved operative safety but the comparative effectiveness and cost-effectiveness of these options remains uncertain.
This study aimed to determine the relative clinical effectiveness and cost-effectiveness of robotic radical prostatectomy compared with laparoscopic radical prostatectomy in the treatment of localised prostate cancer within the UK NHS.
MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, BIOSIS, Science Citation Index and Cochrane Central Register of Controlled Trials were searched from January 1995 until October 2010 for primary studies. Conference abstracts from meetings of the European, American and British Urological Associations were also searched. Costs were obtained from NHS sources and the manufacturer of the robotic system. Economic model parameters and distributions not obtained in the systematic review were derived from other literature sources and an advisory expert panel.
Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies of men with clinically localised prostate cancer (cT1 or cT2); outcome measures included adverse events, cancer related, functional, patient driven and descriptors of care. Two reviewers abstracted data and assessed the risk of bias of the included studies. For meta-analyses, a Bayesian indirect mixed-treatment comparison was used. Cost-effectiveness was assessed using a discrete-event simulation model.
The searches identified 2722 potentially relevant titles and abstracts, from which 914 reports were selected for full-text eligibility screening. Of these, data were included from 19,064 patients across one RCT and 57 non-randomised comparative studies, with very few studies considered at low risk of bias. The results of this study, although associated with some uncertainty, demonstrated that the outcomes were generally better for robotic than for laparoscopic surgery for major adverse events such as blood transfusion and organ injury rates and for rate of failure to remove the cancer (positive margin) (odds ratio 0.69; 95% credible interval 0.51 to 0.96; probability outcome favours robotic prostatectomy = 0.987). The predicted probability of a positive margin was 17.6% following robotic prostatectomy compared with 23.6% for laparoscopic prostatectomy. Restriction of the meta-analysis to studies at low risk of bias did not change the direction of effect but did decrease the precision of the effect size. There was no evidence of differences in cancer-related, patient-driven or dysfunction outcomes. The results of the economic evaluation suggested that when the difference in positive margins is equivalent to the estimates in the meta-analysis of all included studies, robotic radical prostatectomy was on average associated with an incremental cost per quality-adjusted life-year that is less than threshold values typically adopted by the NHS (£30,000) and becomes further reduced when the surgical capacity is high.
The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction.
This study demonstrated that robotic prostatectomy had lower perioperative morbidity and a reduced risk of a positive surgical margin compared with laparoscopic prostatectomy although there was considerable uncertainty. Robotic prostatectomy will always be more costly to the NHS because of the fixed capital and maintenance charges for the robotic system. Our modelling showed that this excess cost can be reduced if capital costs of equipment are minimised and by maintaining a high case volume for each robotic system of at least 100-150 procedures per year. This finding was primarily driven by a difference in positive margin rate. There is a need for further research to establish how positive margin rates impact on long-term outcomes.
The National Institute for Health Research Health Technology Assessment programme.
根治性前列腺切除术是治疗局限性前列腺癌最常用的治疗方法，即完全切除前列腺。腹腔镜（钥匙孔）和机器人辅助手术的使用提高了手术的安全性，但这些选择的相对有效性和成本效益仍然不确定。
本研究旨在确定在英国国民保健制度中，与腹腔镜根治性前列腺切除术相比，机器人根治性前列腺切除术在治疗局限性前列腺癌方面的相对临床效果和成本效益。
从 1995 年 1 月至 2010 年 10 月，对主要研究进行了 MEDLINE、MEDLINE 正在处理和其他非索引引文、EMBASE、BIOSIS、科学引文索引和 Cochrane 对照试验中心注册库的检索。还检索了欧洲、美国和英国泌尿协会会议的会议摘要。成本来自 NHS 来源和机器人系统制造商。未在系统评价中获得的经济模型参数和分布情况是从其他文献来源和顾问专家小组中得出的。
考虑了随机对照试验（RCT）和非随机对照研究的证据，这些研究涉及具有临床局限性前列腺癌（cT1 或 cT2）的男性；结局指标包括不良事件、癌症相关、功能、患者驱动和护理描述符。两名评审员提取数据并评估纳入研究的偏倚风险。对于荟萃分析，使用贝叶斯间接混合治疗比较。使用离散事件模拟模型评估成本效益。
搜索确定了 2722 个潜在相关标题和摘要，其中 914 个报告被选为全文资格筛选。其中，来自一项 RCT 和 57 项非随机对照研究的 19064 名患者的数据被纳入研究，其中很少有研究被认为具有低偏倚风险。尽管存在一些不确定性，但这项研究的结果表明，与腹腔镜手术相比，机器人手术在主要不良事件（如输血和器官损伤率以及癌症切除失败率（阳性边缘）方面的结果通常更好（优势比 0.69；95%可信区间 0.51 至 0.96；机器人前列腺切除术结果概率有利 = 0.987）。与腹腔镜前列腺切除术相比，机器人前列腺切除术后阳性边缘的预测概率为 17.6%。将荟萃分析限制在低偏倚风险的研究中并没有改变效果的方向，但确实降低了效果大小的精度。没有证据表明癌症相关、患者驱动或功能障碍的结果存在差异。经济评估的结果表明，当阳性边缘的差异与所有纳入研究的荟萃分析中的估计值相当时，机器人根治性前列腺切除术的增量成本效益每质量调整生命年（质量调整生命年）都低于 NHS 通常采用的阈值（30000 英镑），并且当手术能力较高时进一步降低。
主要的局限性是关于癌症相关结果和功能障碍的数据的数量和质量有限。
本研究表明，与腹腔镜前列腺切除术相比，机器人前列腺切除术具有较低的围手术期发病率和降低的阳性手术边缘风险，尽管存在相当大的不确定性。由于机器人系统的固定资本和维护费用，机器人前列腺切除术对国民保健制度来说总是更昂贵。我们的模型表明，如果设备的资本成本最小化，并且每年至少维持 100-150 例机器人系统的高病例量，这种额外的成本可以降低。这一发现主要是由阳性边缘率的差异驱动的。需要进一步的研究来确定阳性边缘率如何影响长期结果。
国家卫生研究院卫生技术评估计划。
