英国谢菲尔德大学James W. F. Catto团队研究了机器人辅助根治性膀胱切除术与开放式根治性膀胱切除术对膀胱癌患者90天发病率和死亡率的影响。2022年5月15日出版的《美国医学会杂志》发表了这项成果。

目前临床上机器人辅助根治性膀胱切除术应用越来越频繁，但与开放式根治性膀胱切除术相比，全膀胱切除术是否能改善膀胱癌的恢复尚不明确。    

该研究旨在比较机器人辅助根治性膀胱切除术与开放性根治性膀胱切除术后的恢复情况和发病率。2017年3月至2020年3月，研究组在英国9个机构招募非转移性膀胱癌患者，进行了一项随机临床试验。随访时间分别为90天、6个月和12个月，最终随访时间为2021年9月23日。

将参与者随机分组，其中169例接受机器人辅助的根治性膀胱切除术和体内重建，169例接受开放性根治性膀胱切除术。主要结局是手术后90天内存活出院的天数。20个次要结局包括并发症、生活质量、残疾、耐力、活动水平和生存率。根据分流和机构类型对分析结果进行了校正。

在338名随机参与者中，317名接受了根治性膀胱切除术，平均年龄69岁，67名（21%）为女性；107名（34%）接受了新辅助化疗；282名（89%）接受了回肠导管重建；对305例（96%）患者的主要结局进行分析。

接受机器人辅助手术的患者手术后90天内存活出院的平均天数为82天，而接受开放手术的患者为80天，校正后的差异为2.2天，组间差异显著。与开放手术相比，机器人辅助手术组患者的血栓栓塞并发症和伤口并发症发生率分别为1.9%和5.6%，均显著低于开放手术组（8.3%与16.0%）。

开放手术组参与者在5周时的生活质量显著差于机器人辅助手术组，5周和12周时的残疾程度也比机器人辅助手术组更严重，但12周后的差异不显著。中位随访18.4个月后，两组的癌症复发率（分别为29/161[18%]和25/156[16%]）和总死亡率（分别为23/161[14.3%]和23/156[14.7%]）在统计学上没有显著差异。

研究结果表明，在接受根治性膀胱切除术的非转移性膀胱癌患者中，采用机器人辅助的根治性膀胱切除术加体内重建术与开放性根治性膀胱切除术相比，90天内存活出院天数在统计学上显著增加。但这些发现的临床重要性仍不确定。

附：英文原文

Title: Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial

Author: James W. F. Catto, Pramit Khetrapal, Federico Ricciardi, Gareth Ambler, Norman R. Williams, Tarek Al-Hammouri, Muhammad Shamim Khan, Ramesh Thurairaja, Rajesh Nair, Andrew Feber, Simon Dixon, Senthil Nathan, Tim Briggs, Ashwin Sridhar, Imran Ahmad, Jaimin Bhatt, Philip Charlesworth, Christopher Blick, Marcus G. Cumberbatch, Syed A. Hussain, Sanjeev Kotwal, Anthony Koupparis, John McGrath, Aidan P. Noon, Edward Rowe, Nikhil Vasdev, Vishwanath Hanchanale, Daryl Hagan, Chris Brew-Graves, John D. Kelly, iROC Study Team, E Ruth Groves, Louise Goodwin, Jayne Willson, Phillip Ravencroft, Stephen Kennish, Derek J Rosario, Carol Torrington, Rajesh Nair, Ramesh Thurairaja, Sue Amery, Kathryn Chatterton, Samantha Broadhead, David Hendry, Abdullah Zreik, Sunjay Jain, Steve Prescott, Hannah Roberts, Angela Morgan, Chris Main, Elspeth Bedford, Lorraine Wiseman, Bernice Mpofu, Claire Daisey, Michelle Donachie, Jon Aning, Lyndsey Johnson, Carol Brain, Constance Shiridzinomwa, Martin Ebon, Alexander Hampson, Roisin Schimmel, Scott Horsley, Sayyida Nembhard, Clare Collins, Jemma Gilmore, Faith Wilson, Louise Peacock, Sheena Lim, Rhosyll Gabriel, Rachael Sarpong, Melanie Tan

Issue&Volume: 2022-05-15

Abstract:

Importance  Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer.

Objectives  To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy.

Design, Setting, and Participants  Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021.

Interventions  Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n=169) or open radical cystectomy (n=169).

Main Outcomes and Measures  The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center.

Results  Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P=.01). Thromboembolic complications (1.9% vs 8.3%; difference, –6.5% [95% CI, –11.4% to –1.4%]) and wound complications (5.6% vs 16.0%; difference, –11.7% [95% CI, –18.6% to –4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, –0.07 [95% CI, –0.11 to –0.03]; P=.003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P=.003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P=.01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1).

Conclusions and Relevance  Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain.

DOI: 10.1001/jama.2022.7393

Source: https://jamanetwork.com/journals/jama/fullarticle/2792543