Review question
For patients with bladder cancer that involves the deep muscle wall, does use of a robotic device lead to better or worse outcomes than open surgery?
Background
Patients with bladder cancer that involves the deep muscle wall are best treated by an operation that removes the entire bladder and creates an artificial bladder or channel from the bowel to allow urine to drain to the outside world. This has been done traditionally through open surgery using one large incision. Recently, this operation has been performed with robotic assistance using several small incisions. It is uncertain which approach is better.
Study characteristics
We performed a comprehensive literature search until 1 July 2018. We found five trials comparing robotic assisted versus open surgery. The total number of participants in these trials was 541. Four studies were conducted in the USA and one in the UK.
Key results
There may be little to no difference in the time to recurrence, the rate of major complications or minor complications, quality of life, and rates of positive margins (signalling that cancer may have been left behind). Robotic surgery probably results in fewer blood transfusions and may lead to a slightly shorter hospital stay when compared with open surgery.
Certainty of evidence
Reviewers rated the certainty of evidence as low for most outcomes, except for minor complications (very low) and transfusions (moderate). This means that the true results for these outcomes could be quite different.
Robotic cystectomy and open cystectomy may have similar outcomes with regard to time to recurrence, rates of major complications, quality of life, and positive margin rates (all low-certainty evidence). We are very uncertain whether the robotic approach reduces rates of minor complications (very low-certainty evidence), although it probably reduces the risk of blood transfusions substantially (moderate-certainty evidence) and may reduce hospital stay slightly (low-certainty evidence). We were unable to conduct any of the preplanned subgroup analyses to assess the impact of patient age, pathological stage, body habitus, or surgeon expertise on outcomes. This review did not address issues of cost-effectiveness.
It has been suggested that in comparison with open radical cystectomy, robotic-assisted radical cystectomy results in less blood loss, shorter convalescence, and fewer complications with equivalent short-term oncological and functional outcomes; however, uncertainty remains as to the magnitude of these benefits.
To assess the effects of robotic-assisted radical cystectomy versus open radical cystectomy in adults with bladder cancer.
Review authors conducted a comprehensive search with no restrictions on language of publication or publication status for studies comparing open radical cystectomy and robotic-assisted radical cystectomy. The date of the last search was 1 July 2018 for the Cochrane Central Register of Controlled Trials, MEDLINE (1999 to July 2018), PubMed Embase (1999 to July 2018), Web of Science (1999 to July 2018), Cancer Research UK (www.cancerresearchuk.org/), and the Institute of Cancer Research (www.icr.ac.uk/). We searched the following trials registers: ClinicalTrials.gov (clinicaltrials.gov/), BioMed Central International Standard Randomized Controlled Trials Number (ISRCTN) Registry (www.isrctn.com), and the World Health Organization International Clinical Trials Registry Platform.
We searched for randomised controlled trials that compared robotic-assisted radical cystectomy (RARC) with open radical cystectomy (ORC).
This study was based on a published protocol. Primary outcomes of the review were recurrence-free survival and major postoperative complications (class III to V). Secondary outcomes were minor postoperative complications (class I and II), transfusion requirement, length of hospital stay (days), quality of life, and positive margins (%). Three review authors independently assessed relevant titles and abstracts of records identified by the literature search to determine which studies should be assessed further. Two review authors assessed risk of bias using the Cochrane risk of bias tool and rated the quality of evidence according to GRADE. We used Review Manager 5 to analyse the data.
We included in the review five randomised controlled trials comprising a total of 541 participants. Total numbers of participants included in the ORC and RARC cohorts were 270 and 271, respectively.
Primary outomes
Time-to-recurrence: Robotic cystectomy and open cystectomy may result in a similar time to recurrence (hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.77 to 1.43); 2 trials; low-certainty evidence). In absolute terms at 5 years of follow-up, this corresponds to 16 more recurrences per 1000 participants (95% CI 79 fewer to 123 more) with 431 recurrences per 1000 participants for ORC. We downgraded the certainty of evidence for study limitations and imprecision.
Major complications (Clavien grades 3 to 5): Robotic cystectomy and open cystectomy may result in similar rates of major complications (risk ratio (RR) 1.06, 95% CI 0.76 to 1.48); 5 trials; low-certainty evidence). This corresponds to 11 more major complications per 1000 participants (95% CI 44 fewer to 89 more). We downgraded the certainty of evidence for study limitations and imprecision.
Secondary outcomes
Minor complications (Clavien grades 1 and 2): We are very uncertain whether robotic cystectomy may reduce minor complications (very low-certainty evidence). We downgraded the certainty of evidence for study limitations and for very serious imprecision.
Transfusion rate: Robotic cystectomy probably results in substantially fewer transfusions than open cystectomy (RR 0.58, 95% CI 0.43 to 0.80; 2 trials; moderate-certainty evidence). This corresponds to 193 fewer transfusions per 1000 participants (95% CI 262 fewer to 92 fewer) based on 460 transfusion per 1000 participants for ORC. We downgraded the certainty of evidence for study limitations.
Hospital stay: Robotic cystectomy may result in a slightly shorter hospital stay than open cystectomy (mean difference (MD) -0.67, 95% CI -1.22 to -0.12); 5 trials; low-certainty evidence). We downgraded the certainty of evidence for study limitations and imprecision.
Quality of life: Robotic cystectomy and open cystectomy may result in a similar quality of life (standard mean difference (SMD) 0.08, 95% CI 0.32 lower to 0.16 higher; 3 trials; low-certainty evidence). We downgraded the certainty of evidence for study limitations and imprecision.
Positive margin rates: Robotic cystectomy and open cystectomy may result in similar positive margin rates (RR 1.16, 95% CI 0.56 to 2.40; 5 trials; low-certainty evidence). This corresponds to 8 more (95% CI 21 fewer to 67 more) positive margins per 1000 participants based on 48 positive margins per 1000 participants for ORC. We downgraded the certainty of evidence for study limitations and imprecision.