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

Catto, J. W. F.; Khetrapal, P.; Ricciardi, F.; Ambler, G.; Williams, N. R.; Al-Hammouri, T.; Khan, M. S.; Thurairaja, R.; Nair, R.; Feber, A.; Dixon, S.; Nathan, S.; Briggs, T.; Sridhar, A.; Ahmad, I.; Bhatt, J.; Charlesworth, P.; Blick, C.; Cumberbatch, M. G.; Hussain, S. A.; Kotwal, S.; Koupparis, A.; McGrath, J.; Noon, A. P.; Rowe, E.; Vasdev, N.; Hanchanale, V.; Hagan, D.; Brew-Graves, C.; Kelly, J. D.

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dc.creator	Catto, J. W. F.
dc.creator	Khetrapal, P.
dc.creator	Ricciardi, F.
dc.creator	Ambler, G.
dc.creator	Williams, N. R.
dc.creator	Al-Hammouri, T.
dc.creator	Khan, M. S.
dc.creator	Thurairaja, R.
dc.creator	Nair, R.
dc.creator	Feber, A.
dc.creator	Dixon, S.
dc.creator	Nathan, S.
dc.creator	Briggs, T.
dc.creator	Sridhar, A.
dc.creator	Ahmad, I.
dc.creator	Bhatt, J.
dc.creator	Charlesworth, P.
dc.creator	Blick, C.
dc.creator	Cumberbatch, M. G.
dc.creator	Hussain, S. A.
dc.creator	Kotwal, S.
dc.creator	Koupparis, A.
dc.creator	McGrath, J.
dc.creator	Noon, A. P.
dc.creator	Rowe, E.
dc.creator	Vasdev, N.
dc.creator	Hanchanale, V.
dc.creator	Hagan, D.
dc.creator	Brew-Graves, C.
dc.creator	Kelly, J. D.
dc.date	2022-12-08T14:30:20Z
dc.date	2022-12-08T14:30:20Z
dc.date	2022-06-07
dc.date	2022-05-16
dc.date.accessioned	2023-02-17T19:48:04Z
dc.date.available	2023-02-17T19:48:04Z
dc.identifier	JAMA. 2022 Jun 7;327(21):2092-2103. doi: 10.1001/jama.2022.7393.
dc.identifier	35569079
dc.identifier	10.1001/jama.2022.7393
dc.identifier	https://rde.dspace-express.com/handle/11287/622574
dc.identifier	Jama
dc.identifier	PMC9109000 consultancy from AstraZeneca, Ferring, Roche, and Janssen; speaker fees from Bristol Myers Squibb, Merck Sharp & Dohme, Janssen, Astellas, Nucleix, and Roche; honoraria for membership in advisory boards from Ferring, Roche, Gilead, Photocure, Bristol Myers Squibb, QED Therapeutics, and Janssen; and research funding from Roche. Mr Sridhar reported receiving research funding and payment for proctorship from Intuitive Surgical. Dr Ahmad reported receiving payment for proctorship from Intuitive Surgical. Dr Hussain reported receiving reimbursement for consultancy from Pierre Fabre, Bayer, Janssen Oncology, Roche, Merck, Bristol Myers Squibb, AstraZeneca, Pfizer, Astellas, and GlaxoSmithKline; research funding from Cancer Research UK, the Medical Research Council/National Institute for Health and Care Research (NIHR), Boehringer Ingelheim, Roche, Janssen-Cilag, and Pierre Fabre; support for attending meetings and/or travel from Janssen-Cilag, Bayer, Boehringer Ingelheim, Pierre Fabre, Pfizer, Roche, Bristol Myers Squibb, AstraZeneca, and Merck Sharp & Dohme Oncology. Dr Koupparis reported receiving payment for proctorship from Intuitive Surgical. Dr McGrath reported receiving educational funding from Intuitive Surgical. Dr Noon reported receiving financial support for travel from Intuitive Surgical. No other disclosures were reported.
dc.identifier.uri	http://localhost:8080/xmlui/handle/CUHPOERS/242001
dc.description	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. TRIAL REGISTRATION: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.
dc.description	RD&E staff can access the full-text of this article by clicking on the 'Additional Link' above and logging in with NHS OpenAthens if prompted.
dc.description	Not permitted
dc.language	eng
dc.publisher	JAMA
dc.rights	2022 American Medical Association
dc.rights	http://creativecommons.org/publicdomain/zero/1.0/
dc.subject	Aged
dc.subject	*Cystectomy/adverse effects/methods/mortality
dc.subject	Female
dc.subject	Humans
dc.subject	Male
dc.subject	Morbidity
dc.subject	Neoplasm Recurrence, Local
dc.subject	Postoperative Complications/etiology
dc.subject	Quality of Life
dc.subject	Retrospective Studies
dc.subject	*Robotic Surgical Procedures/adverse effects/methods/mortality
dc.subject	*Robotics
dc.subject	Treatment Outcome
dc.subject	*Urinary Bladder Neoplasms/mortality/pathology/surgery
dc.subject	*Urinary Diversion/adverse effects/methods/mortality
dc.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
dc.type	Randomized Controlled Trial
dc.type	ppublish