Robotic vs. Open Radical Cystectomy: 3-Year RCT Results Revealed - Giuseppe Simone
June 26, 2024
Ashish Kamat hosts Giuseppe Simone to discuss a randomized trial that compares robotic-assisted radical cystectomy with completely intracorporeal urinary diversion to the traditional open approach. Published three-year outcomes demonstrate a notable reduction in preoperative transfusion rates for the robotic approach, though costs were higher due to surgical devices. Functional outcomes such as nighttime urinary continence initially showed differences favoring the open approach but these differences diminished over time. Both surgical techniques showed comparable results in perioperative complications and survival outcomes, underlining the technological equivalence in skilled hands, despite cost differences. This study importantly guides surgical decisions and training, reflecting the ongoing shift towards robotic procedures in surgical practice.
Biographies:
Giuseppe Simone, Md, PhD, FEBU, Consultant Urologist, Principal Investigator, IRCSS, “Regina Elena” National Cancer Institute, Rome, Italy
Ashish Kamat, MD, MBBS, Professor of Urology and Wayne B. Duddleston Professor of Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, TX
Biographies:
Giuseppe Simone, Md, PhD, FEBU, Consultant Urologist, Principal Investigator, IRCSS, “Regina Elena” National Cancer Institute, Rome, Italy
Ashish Kamat, MD, MBBS, Professor of Urology and Wayne B. Duddleston Professor of Cancer Research, University of Texas, MD Anderson Cancer Center, Houston, TX
Read the Full Video Transcript
Ashish Kamat: Hello everybody and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, professor of urologic oncology at MD Anderson Cancer Center in Houston, Texas. It's a pleasure today to welcome, all the way from Rome, Italy, Professor Giuseppe Simone. Giuseppe, thank you so much for taking the time to be with us today. You have a very important prospective randomized trial that you reported recently on the comparison between robotic-assisted radical cystectomy with totally intracorporeal urinary diversion compared to open radical cystectomy. And you published and presented the three-year outcomes from this RCT. Very important data, finally comparing in some ways apples to apples. So, we're all excited to hear what you have to say and please take it away.
Giuseppe Simone: Thank you. Thank you for this opportunity. So, let's start from the background of the study. We have different randomized trials comparing open and robotic cystectomy, but all of these were performed with an extracorporeal urinary diversion. We also know from the LASER trial that oncologic outcomes were comparable between open and robotic cystectomy. When we started the trial, the main point was what about intracorporeal urinary diversions? There was an editorial by the USC team pointing out that the extracorporeal approach was not the best comparison with open radical cystectomy. So, our primary outcome was a significant reduction of overall preoperative transfusion rate, a 50% reduction. Based on this primary endpoint, the sample size was estimated to be 58 patients per arm. The overall transfusion rate was significantly lower in the robotic arm.
What about the secondary outcomes? So, no difference at all in terms of preoperative complications, hospital stay, readmissions, and 30, 90, and six months after surgery. Namely, all these outcomes were largely comparable between the two arms. As expected, the cost analysis was significantly in favor of open radical cystectomy. And this is mainly driven by surgical devices costs. We also know that as expected, according to the RAZOR trial, no difference in all survival outcomes between the two arms. But when we look at the continents' recovery between the two groups, while daytime urinary continence was almost comparable between the two arms, there was a significant difference between nighttime continence in the robotic versus open arm.
According to our feeling, this is largely due to smaller sizes of neobladder performed with robotic cystectomy, and in a longer follow-up, these differences were not so marked as in the initial phase of follow-up. We also observed improved abdominal bloating and flatus, and improved body image in the robotic cystectomy arm. In summary, we were able to demonstrate a significant reduction of transfusion rate, improved body image in the robotic arm, increased cost, but no significant difference in terms of perioperative complications and no significant difference in terms of functional outcomes except for nighttime continence that was, in the initial phase of follow-up, improved in the open cystectomy arm. The take-home message is to look at the data as we reported so that anyone can have an idea about the pros and cons of both approaches. Thank you.
Ashish Kamat: So, thank you so much for that presentation, Giuseppe. It was very concise and very succinct. People often talk about the pros and cons of open radical cystectomy compared to robotic radical cystectomy. I'm sure you agree with me that they're both tools. They're both different ways in which we can perform a radical cystectomy. And the surgery itself, the radical cystectomy, has inherent issues with it when it comes to morbidity, mortality, the clear need to adhere to oncologic principles. And I think you showed very eloquently that in experienced hands, when you do a well-designed study, there is really no detriment to doing a robotic-assisted radical cystectomy. In fact, you might have some improvements in blood transfusion rates as you showed in the primary outcome, and some secondary outcomes. But clearly, that comes at a balance of cost and operative time. So, with that knowledge, how would you advise the audience, the listeners, your trainees, other peers, and colleagues that are thinking about, "Should I use open radical cystectomy? Or should I use robotic-assisted radical cystectomy for bladder cancer?"
Giuseppe Simone: Yeah, this is a very interesting question. I would start from saying that if a surgeon is highly skilled with open cystectomy, let's proceed with a surgical procedure we are confident performing at your own institution. So, no one should be pushed to perform robotic cystectomy as the best way to go. Since there are significant complications in perioperative time after surgery, it's very important to keep in mind that reducing complications, obtaining the best oncological outcomes we can for these patients is the first goal of this surgical procedure.
We also have to keep in mind that robotic surgery has widespread adoption in all centers. At least in Italy, there was a significant trend towards increased adoption of robotic surgery and also robotic cystectomy. So, we have no sufficient data to tell everyone that robotics is better, but we are also facing an increased use of robotic cystectomy worldwide. And this is important also for trainees because in our center, we are almost no longer performing open radical cystectomy. So, for residents, for fellows, for young physicians, it's very difficult to train these guys to perform a good open radical cystectomy. This is something that's happening and it is not driven by data, but by day-to-day practice.
Ashish Kamat: Yeah, important point there because clearly when it comes to day-to-day practice and the realities of the world we live in, and training our young trainees, residents, fellows, we have to factor in exactly what you said. At MD Anderson, we still train our fellows in how to do an open radical cystectomy along with how to do a robotic-assisted radical cystectomy. But some of them have actually never seen an open surgery. Prostatectomy is clearly historic now, and even cystectomy seems to be going that way. So, I think data such as yours that shows that there's definitely no detriment in good hands to doing a completely intracorporeal will help allay some of the fears that people keep having in their minds as to what to do.
But I think the point you raised is very important. Cystectomy, whether robotically or open, has complications. If you're not a skilled robotic surgeon, don't learn on a radical cystectomy. Learn on the other procedures. Do you have any tips or tricks for people that are trying to factor in the cost issues? Because clearly, healthcare costs are an issue. And when you're trying to factor in the cost, say in countries such as India, or in South America, or maybe even in Italy, do you have to factor that in when you talk to your hospital administrators or the healthcare system?
Giuseppe Simone: Well, I mean in centers performing significant robotic caseload, costs are significantly lower than in centers performing robotic surgery for select indications. And this is what we observed in our centers. We came from more or less 10 years ago a period when we were treating patients with open, lap, and robotic procedures. So, there was a selection bias for all of these patients, and we progressively shifted towards a robotic approach. This is a way to significantly reduce costs of robotic surgery. It's something we cannot compare with open surgery. Of course, open surgery is cheaper. But more and more patients are asking for a nerve-sparing procedure for a quick recovery to daily life.
So, robotic is a way of life. So, if you start doing robotic cystectomy every day, I'm pretty sure that you are going to improve your own outcomes. So, I don't want to go back to open cystectomy because this will finally mean performing 15 neobladders with open surgery per year and 15 neobladders with a robotic approach. And this is something that can finally impact negatively on the outcomes for patients. So, if you want to focus on a procedure and understand that we need to train someone else to perform surgery, but the first goal should improve outcomes of our patients. So, I don't think I will go back to open cystectomy based on non-inferiority data of our trial.
Ashish Kamat: Right. And when it comes to things that you mentioned, for example, quicker recovery hospital stay, a lot of it is culturally and regionally dependent because I know there are parts of the world where people stay in the hospital still for 10, 14 days after cystectomy. Whereas at our center, even whether it's open or robotic, they usually go home on post-op day four. But a lot of that is cultural and how it's built into the system, so it's not easy to compare that across the globe.
One last question I want to ask you, because again, it's very important what you mentioned about the fact that the trainees are nowadays getting completely into robotic cystectomy. You, on the other hand, I'm sure if you had to, you could do it laparoscopically, you could do it open. But for the situations where you are having a trainee or someone that's young, and has only done robotic cystectomies, and needs to convert for whatever reason to open, what are some of the practical pearls that you would impart on someone like that as to how they could overcome those practical issues when they're starting out in their career and don't know how to do open surgery? What are some of the guardrails or safety nets that you recommend?
Giuseppe Simone: So, the first recommendation I would give is having someone in your team able to perform open or lap procedures. This is something that today we can do. I'm not sure we can do it in the future. But to be honest, in the past years with a growing experience in robotic surgery, our conversion rate dropped down to close to zero. And this is something we need to consider. We are doing cystectomy also for locally advanced T4 urothelial carcinoma. Those patients four, five, six years ago, we would treat with an open approach. So, roughly 100% of robotic procedures can be safely performed. But in a center where you have no surgeon able to perform open surgery, if you need conversion, you're in trouble. So, we don't know how to face this problem. But for sure in the future, robotic will be close to 100% of surgical procedures.
Ashish Kamat: All right. Thank you so much again for taking the time and spending it with us. Congratulations on completing a well-conducted randomized study and on the publication. And I hope to see you again sometime soon.
Giuseppe Simone: Thank you. Thank you, Ashish. My pleasure.
Ashish Kamat: Hello everybody and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, professor of urologic oncology at MD Anderson Cancer Center in Houston, Texas. It's a pleasure today to welcome, all the way from Rome, Italy, Professor Giuseppe Simone. Giuseppe, thank you so much for taking the time to be with us today. You have a very important prospective randomized trial that you reported recently on the comparison between robotic-assisted radical cystectomy with totally intracorporeal urinary diversion compared to open radical cystectomy. And you published and presented the three-year outcomes from this RCT. Very important data, finally comparing in some ways apples to apples. So, we're all excited to hear what you have to say and please take it away.
Giuseppe Simone: Thank you. Thank you for this opportunity. So, let's start from the background of the study. We have different randomized trials comparing open and robotic cystectomy, but all of these were performed with an extracorporeal urinary diversion. We also know from the LASER trial that oncologic outcomes were comparable between open and robotic cystectomy. When we started the trial, the main point was what about intracorporeal urinary diversions? There was an editorial by the USC team pointing out that the extracorporeal approach was not the best comparison with open radical cystectomy. So, our primary outcome was a significant reduction of overall preoperative transfusion rate, a 50% reduction. Based on this primary endpoint, the sample size was estimated to be 58 patients per arm. The overall transfusion rate was significantly lower in the robotic arm.
What about the secondary outcomes? So, no difference at all in terms of preoperative complications, hospital stay, readmissions, and 30, 90, and six months after surgery. Namely, all these outcomes were largely comparable between the two arms. As expected, the cost analysis was significantly in favor of open radical cystectomy. And this is mainly driven by surgical devices costs. We also know that as expected, according to the RAZOR trial, no difference in all survival outcomes between the two arms. But when we look at the continents' recovery between the two groups, while daytime urinary continence was almost comparable between the two arms, there was a significant difference between nighttime continence in the robotic versus open arm.
According to our feeling, this is largely due to smaller sizes of neobladder performed with robotic cystectomy, and in a longer follow-up, these differences were not so marked as in the initial phase of follow-up. We also observed improved abdominal bloating and flatus, and improved body image in the robotic cystectomy arm. In summary, we were able to demonstrate a significant reduction of transfusion rate, improved body image in the robotic arm, increased cost, but no significant difference in terms of perioperative complications and no significant difference in terms of functional outcomes except for nighttime continence that was, in the initial phase of follow-up, improved in the open cystectomy arm. The take-home message is to look at the data as we reported so that anyone can have an idea about the pros and cons of both approaches. Thank you.
Ashish Kamat: So, thank you so much for that presentation, Giuseppe. It was very concise and very succinct. People often talk about the pros and cons of open radical cystectomy compared to robotic radical cystectomy. I'm sure you agree with me that they're both tools. They're both different ways in which we can perform a radical cystectomy. And the surgery itself, the radical cystectomy, has inherent issues with it when it comes to morbidity, mortality, the clear need to adhere to oncologic principles. And I think you showed very eloquently that in experienced hands, when you do a well-designed study, there is really no detriment to doing a robotic-assisted radical cystectomy. In fact, you might have some improvements in blood transfusion rates as you showed in the primary outcome, and some secondary outcomes. But clearly, that comes at a balance of cost and operative time. So, with that knowledge, how would you advise the audience, the listeners, your trainees, other peers, and colleagues that are thinking about, "Should I use open radical cystectomy? Or should I use robotic-assisted radical cystectomy for bladder cancer?"
Giuseppe Simone: Yeah, this is a very interesting question. I would start from saying that if a surgeon is highly skilled with open cystectomy, let's proceed with a surgical procedure we are confident performing at your own institution. So, no one should be pushed to perform robotic cystectomy as the best way to go. Since there are significant complications in perioperative time after surgery, it's very important to keep in mind that reducing complications, obtaining the best oncological outcomes we can for these patients is the first goal of this surgical procedure.
We also have to keep in mind that robotic surgery has widespread adoption in all centers. At least in Italy, there was a significant trend towards increased adoption of robotic surgery and also robotic cystectomy. So, we have no sufficient data to tell everyone that robotics is better, but we are also facing an increased use of robotic cystectomy worldwide. And this is important also for trainees because in our center, we are almost no longer performing open radical cystectomy. So, for residents, for fellows, for young physicians, it's very difficult to train these guys to perform a good open radical cystectomy. This is something that's happening and it is not driven by data, but by day-to-day practice.
Ashish Kamat: Yeah, important point there because clearly when it comes to day-to-day practice and the realities of the world we live in, and training our young trainees, residents, fellows, we have to factor in exactly what you said. At MD Anderson, we still train our fellows in how to do an open radical cystectomy along with how to do a robotic-assisted radical cystectomy. But some of them have actually never seen an open surgery. Prostatectomy is clearly historic now, and even cystectomy seems to be going that way. So, I think data such as yours that shows that there's definitely no detriment in good hands to doing a completely intracorporeal will help allay some of the fears that people keep having in their minds as to what to do.
But I think the point you raised is very important. Cystectomy, whether robotically or open, has complications. If you're not a skilled robotic surgeon, don't learn on a radical cystectomy. Learn on the other procedures. Do you have any tips or tricks for people that are trying to factor in the cost issues? Because clearly, healthcare costs are an issue. And when you're trying to factor in the cost, say in countries such as India, or in South America, or maybe even in Italy, do you have to factor that in when you talk to your hospital administrators or the healthcare system?
Giuseppe Simone: Well, I mean in centers performing significant robotic caseload, costs are significantly lower than in centers performing robotic surgery for select indications. And this is what we observed in our centers. We came from more or less 10 years ago a period when we were treating patients with open, lap, and robotic procedures. So, there was a selection bias for all of these patients, and we progressively shifted towards a robotic approach. This is a way to significantly reduce costs of robotic surgery. It's something we cannot compare with open surgery. Of course, open surgery is cheaper. But more and more patients are asking for a nerve-sparing procedure for a quick recovery to daily life.
So, robotic is a way of life. So, if you start doing robotic cystectomy every day, I'm pretty sure that you are going to improve your own outcomes. So, I don't want to go back to open cystectomy because this will finally mean performing 15 neobladders with open surgery per year and 15 neobladders with a robotic approach. And this is something that can finally impact negatively on the outcomes for patients. So, if you want to focus on a procedure and understand that we need to train someone else to perform surgery, but the first goal should improve outcomes of our patients. So, I don't think I will go back to open cystectomy based on non-inferiority data of our trial.
Ashish Kamat: Right. And when it comes to things that you mentioned, for example, quicker recovery hospital stay, a lot of it is culturally and regionally dependent because I know there are parts of the world where people stay in the hospital still for 10, 14 days after cystectomy. Whereas at our center, even whether it's open or robotic, they usually go home on post-op day four. But a lot of that is cultural and how it's built into the system, so it's not easy to compare that across the globe.
One last question I want to ask you, because again, it's very important what you mentioned about the fact that the trainees are nowadays getting completely into robotic cystectomy. You, on the other hand, I'm sure if you had to, you could do it laparoscopically, you could do it open. But for the situations where you are having a trainee or someone that's young, and has only done robotic cystectomies, and needs to convert for whatever reason to open, what are some of the practical pearls that you would impart on someone like that as to how they could overcome those practical issues when they're starting out in their career and don't know how to do open surgery? What are some of the guardrails or safety nets that you recommend?
Giuseppe Simone: So, the first recommendation I would give is having someone in your team able to perform open or lap procedures. This is something that today we can do. I'm not sure we can do it in the future. But to be honest, in the past years with a growing experience in robotic surgery, our conversion rate dropped down to close to zero. And this is something we need to consider. We are doing cystectomy also for locally advanced T4 urothelial carcinoma. Those patients four, five, six years ago, we would treat with an open approach. So, roughly 100% of robotic procedures can be safely performed. But in a center where you have no surgeon able to perform open surgery, if you need conversion, you're in trouble. So, we don't know how to face this problem. But for sure in the future, robotic will be close to 100% of surgical procedures.
Ashish Kamat: All right. Thank you so much again for taking the time and spending it with us. Congratulations on completing a well-conducted randomized study and on the publication. And I hope to see you again sometime soon.
Giuseppe Simone: Thank you. Thank you, Ashish. My pleasure.