Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: 24-month outcomes from a randomised controlled study

医学 性功能 前列腺切除术 泌尿科 前列腺癌 尿失禁 腹腔镜前列腺根治术 根治性耻骨后前列腺切除术 尿失禁 随机对照试验 生活质量(医疗保健) 国际前列腺症状评分 外科 癌症 下尿路症状 前列腺 内科学 护理部
作者
Geoffrey D. Coughlin,John Yaxley,Suzanne K. Chambers,Stefano Occhipinti,Hemamali Samaratunga,Leah Zajdlewicz,Patrick Telöken,Nigel Dunglison,Scott Williams,Martin F. Lavin,Robert A. Gardiner
出处
期刊:Lancet Oncology [Elsevier BV]
卷期号:19 (8): 1051-1060 被引量:320
标识
DOI:10.1016/s1470-2045(18)30357-7
摘要

Previous trials have found similar early outcomes after robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy. We report functional and oncological postoperative outcomes up to 24 months after surgery for these two surgical techniques.In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD, Australia). Participants were randomly assigned (1:1) to have either robot-assisted laparoscopic prostatectomy or open radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's surgical treatment. Primary outcomes were urinary function (urinary domain of Expanded Prostate Cancer Index Composite [EPIC]) and sexual function (sexual domain of EPIC and International Index of Erectile Function Questionnaire [IIEF]) at 6 months, 12 months, and 24 months and oncological outcome (biochemical recurrence and imaging evidence of progression). The trial was powered to assess health-related and domain-specific quality-of-life outcomes over 24 months. All analyses were done on a per-protocol basis. The trial was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000661976.Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to robot-assisted laparoscopic prostatectomy and 163 to open radical retropubic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group and 157 in the robot-assisted laparoscopic prostatectomy group proceeded to surgery. At the 24-month follow-up time point, 150 men remained in the robot-assisted laparoscopic prostatectomy group and 146 remained in the open radical retropubic prostatectomy group. Urinary function scores did not differ significantly between robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy at 6 months post-surgery (88·68 [95% CI 86·79-90·58] vs 88·45 [86·54-90·36]; p1<0·0001, p2<0·0001), 12 months post-surgery (90·76 [88·89-92·62] vs 91·53 [90·07-92·98]; p1<0·0001, p2<0·0001), or 24 months post-surgery (91·33 [89·64-93·03] vs 90·86 [89·01-92·70]; p1<0·0001, p2<0·0001). Sexual function scores were not significantly different between robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy at 6 months post-surgery (EPIC: 37·40 [33·60-41·19] vs 38·63 [34·76-42·49], p1=0·0001, p2<0·0001; IIEF: 29·75 [26·66-32·84] vs 29·78 [26·41-33·16], p1<0·0001, p2<0·0001), 12 months post-surgery (EPIC: 42·28 [38·05-46·51] vs 42·51 [38·29-46·72], p1<0·0001, p2<0·0001; IIEF: 33·10 [29·59-36·61] vs 33·50 [29·87-37·13], p1=0·0002, p2<0·0001), or 24 months post-surgery (EPIC: 45·70 [41·17-50·23] vs 46·90 [42·20-51·60], p1=0·0003, p2<0·0001; IIEF: 33·95 [30·11-37·78] vs 33·89 [29·82-37·96], p1=0·0003, p2=0·0004). Equivalence testing on the difference between the proportion of biochemical recurrences between the two groups (13 [9%] in the open radical retropubic prostatectomy group vs four [3%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a prespecified margin of 10%. However, a superiority test showed that the two proportions were significantly different (p=0·0199). Equivalence testing on the proportion of patients who had imaging evidence of progression revealed that the two groups were not significantly different (p=0·2956).Robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy yielded similar functional outcomes at 24 months. We advise caution in interpreting the oncological outcomes of our study because of the absence of standardisation in postoperative management between the two trial groups and the use of additional cancer treatments. Clinicians and patients should view the benefits of a robotic approach as being largely related to its minimally invasive nature.Cancer Council Queensland.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
嘿嘿完成签到,获得积分10
3秒前
yr完成签到 ,获得积分10
4秒前
4秒前
王道远完成签到,获得积分10
4秒前
Jasper应助zhouleiwang采纳,获得10
4秒前
123完成签到,获得积分10
5秒前
虎妞完成签到 ,获得积分10
5秒前
积极晓绿完成签到,获得积分10
5秒前
EaRnn发布了新的文献求助10
6秒前
现代的卿完成签到 ,获得积分10
6秒前
拉长的服饰完成签到,获得积分10
7秒前
香菜大王完成签到 ,获得积分10
7秒前
7秒前
愉快静曼发布了新的文献求助10
7秒前
奋斗人雄完成签到,获得积分10
9秒前
小v完成签到 ,获得积分10
9秒前
Gigi完成签到,获得积分10
10秒前
ssssssssci完成签到,获得积分10
10秒前
Owen应助大气灵枫采纳,获得10
11秒前
独特乘风完成签到,获得积分10
14秒前
含糊的代丝完成签到 ,获得积分10
17秒前
朴素的紫安完成签到 ,获得积分10
18秒前
yyj完成签到,获得积分10
19秒前
20秒前
20秒前
量子星尘发布了新的文献求助10
20秒前
君临完成签到,获得积分10
20秒前
林早上完成签到,获得积分20
20秒前
xiu完成签到 ,获得积分10
21秒前
栗爷完成签到,获得积分0
21秒前
深年完成签到,获得积分10
22秒前
求知若渴完成签到,获得积分0
22秒前
所所应助科研通管家采纳,获得10
22秒前
情怀应助科研通管家采纳,获得10
22秒前
华仔应助科研通管家采纳,获得30
22秒前
李爱国应助科研通管家采纳,获得10
23秒前
Orange应助科研通管家采纳,获得10
23秒前
我是老大应助科研通管家采纳,获得10
23秒前
华仔应助科研通管家采纳,获得10
23秒前
SciGPT应助科研通管家采纳,获得10
23秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
Research on Disturbance Rejection Control Algorithm for Aerial Operation Robots 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038388
求助须知:如何正确求助?哪些是违规求助? 3576106
关于积分的说明 11374447
捐赠科研通 3305798
什么是DOI,文献DOI怎么找? 1819322
邀请新用户注册赠送积分活动 892672
科研通“疑难数据库(出版商)”最低求助积分说明 815029