Max Kates: Hi, thanks so much, Sam. It's great to be with you, and it's especially great to be here with one of our star chief residents here at Johns Hopkins. My name is Max Kates. I'm on faculty at Hopkins, a urologic oncologist, specialized primarily in bladder cancer. Again, we're talking here today about TURBT, something many of us do all the time, and yet there is, as I think you'll see, a lot of room for improvements, small improvements that lead up to large improvements.
Michelle Higgins: And thank you so much for having us. My name is Michelle Higgins. I'm a chief resident at Johns Hopkins in urology, and I'll be discussing our work today on enhanced recovery-after-surgery protocol for TURBT. All right, thank you. I'll be discussing the results from our ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care, or EMBRACE, Randomized Controlled Trial. As we were discussing, transurethral resection of a bladder tumor is often described to patients as well-tolerated and incision-free procedure that we do extremely commonly as urologists. However, with more discussion with patients, TURBT is not an entirely benign procedure. It involves a good deal of physical symptoms such as pain, psychological symptoms such as anxiety, lower urinary tract dysfunction, as well as occasionally complications perioperatively. Given that this is such a common surgery, we wanted to see how we could do better essentially for our patients, so we looked into developing an enhanced recovery-after-surgery protocol, which is typically thought of as done for larger surgeries with more extended inpatient stays such as cystectomy. But we started looking into this for ambulatory TURBT in order to enhance patient recovery. Our approach was patient-centered, and by that, I mean, we started by talking to patients.
The initial approach we took was doing a needs assessment. This was a multicenter cohort of patients, 150 patients undergoing TURBT, where we spoke with them about characterizing their experience of the surgery and recovery from surgery, as well as various toxicities they experienced. We also performed a literature review, a patient advisory panel, and a clinical advisory panel of multiple different stakeholders that take care of bladder cancer patients in order to develop an enhanced recovery-after-surgery pathway. For our ERAS protocol for ambulatory TURBT, this first started with changes to our preoperative protocol, and we started with creating a detailed procedure handbook that we would give to all of our patients undergoing TURBT. This included additional catheter education preoperatively, as well as a few specific interventions such as constipation prevention for patients. Intraoperatively, we did also develop a standardized protocol of anesthesia practices, and had our anesthesia colleagues involved in this, as well as a few surgical best practices such as for hemostasis, for decreasing the number of times the cystoscope is passed in and out of the urethra, and analgesia such as lidocaine jelly used in the operating room after surgery.
Then postoperatively, we honed a pathway that had standardization of detailed discharge instructions, as well as specific steps for nursing to walk the patient through prior to being discharged such as in-depth catheter education. The EMBRACE trial was a single-center randomized controlled trial developed to evaluate this ERAS protocol, and this ran from July of 2023 to May of 2024 with a hundred patients enrolled. The purpose was to evaluate this ERAS protocol designed by both patients and the providers that take care of them to improve their recovery surrounding ambulatory TURBT. Patients were randomized in a one-to-one fashion between ERAS and control with a hundred patients total. The primary endpoint was this Quality Of Recovery 15 score measured at baseline day of surgery and postoperative day one. The Quality of Recovery 15 score was actually developed in the anesthesia literature initially, but it's a validated 15-item score that looks at multiple domains of recovery after surgery, such as physical symptoms, pain, functional and autonomy, emotional recovery, and psychological recovery. Our secondary outcomes, we looked at a variety of pain metrics and lower urinary tract symptoms, as well as 30-day complications, emergency room visits, and outpatient clinic visits. For our results, the quality of recovery, our primary outcome score, we found a clinically significant difference and statistically significant 12-point difference between the ERAS group with a higher score being an improved quality of recovery than over the control group. And for secondary outcomes, in terms of pain, we did see a difference of the ERAS group in the dark blue having less urethral pain, penile or vulvar pain, and dysuria.
Other additional outcomes to note, there was less urinary incontinence in the ERAS group with 14% versus 41% of patients experiencing that in the control group. Then fewer outpatient visits within 30 days for the ERAS group and an improved lower urinary tract symptom score for the ERAS group. In conclusion, implementation of this ERAS protocol for ambulatory TURBT did significantly improve recovery and symptom burden for patients, and urologists should consider the benefits of implementing an ERAS protocol for an ambulatory surgery such as TURBT. However, we do need a prospective evaluation in a multi-institutional fashion of this protocol, so that would be our future directions.
Sam Chang: Dr. Kates and Dr. Higgins, I think a home run, right? I mean, you've got the trifecta of outcomes improvement, probably improvement in cost, decreased visits, ER visits, clinic visits, et cetera. And then finally, one that immediately I began thinking of, which would be actually improved physician and clinic burden, a decrease in that. I think by doing all this upfront, during, and afterwards, you've really shown a significant improvement. Just a couple questions. First, in that Quality of Recovery 15 score -- which most urologic surgeons probably wouldn't know, but the fact that it's validated, it's been used, et cetera, I think will be really, really important to emphasize -- statistically a difference, tell me the statistical difference that correlates to a clinical difference for patients. That difference of 15 or so on the bar graph seems big. How does that manifest in terms of a clinical response for patients?
Michelle Higgins: In the anesthesia literature, the clinically significant difference is noted to be somewhere around six, and that's, again, with a big enough difference on all of those point scales, both in physical, functional recovery, psychological, and social support systems for their recovery. This is all patient-rated, so it's patients rating on a scale of 1 to 10, all of those different aspects, using 15 questions. But in terms of this, the study was powered to find a six-point difference to look at a clinically significant, and we actually ended up finding a 12-point difference.
Sam Chang: I mean, you all know, sometimes we have the statistically difference in SF36, all these different questionnaires that we use, but to have one that is so clinically relevant and impactful I think is really important. As you all see that the initial effort that you all put in have actually translated to such a benefit for not only patients, but overall cost of the system, et cetera, Dr. Kates or Dr. Higgins, either one of you, where do we go next? You talked about a multi-institutional trial, prospective, et cetera. Tell me what you want to do next. Are you going to expand it to TURP? Are you going to expand it to et cetera? Tell me your next steps.
Max Kates: Yeah. I mean, so first of all, I think it's important to tell you about how this all came to be, which is we have amazing partners and colleagues outside of urology. In talking to them, actually it was one of our fellows was talking to a fellow from a different specialty, there's outpatient ERAS protocols being designed really all over the place in our institution for thyroid surgery, but also several other ENT-related surgeries and things like that. This is really a growing emphasis, especially as payers start paying attention to quality of outpatient care and things like readmissions outside of outpatient surgeries. There's a lot of reasons why I think urologists should be engaged in this, even outside of the patient-centered care. The system-centered care really should be pushing us to this. I think first and foremost, doing things like this, talking to you, educating urologists in all types of practices, that there's some simple things that they can do to improve TURBTs. In our protocol, all patients intraoperatively are now getting Toradol who don't have CKD. All patients are getting lidocaine jelly after. We are doing the very best we can not to go in and out with the scope. I mean, there are certain things that really all of us can do to limit issues. I think that we wanted to put this into practice to start generating some data, but there's no reason why it can't be done for other outpatient surgeries. I think stone surgeons are already starting to look at this, TURP is another great example, but we could go on and on.
Sam Chang: Yeah. No, really, really good point. What I like that you all have done is taken the systematic approach. Our folks a few years ago really made a big impact in decreasing opioid usage for ureteroscopic stone extraction. That's really honestly taken off. But having a multi-domain impact, the preoperative teaching, involvement of anesthesia, postoperative pain control, instruction afterwards, the use of lidocaine jelly, like you said, post-procedure, all these things, I think every urologic surgeon, I don't know, a single one who wouldn't gain some benefit from, "Wow, look at some of these things." They may not be able to adapt to everything, but to have some of the key points that you all have raised and shown that benefit is, I think, incredibly impactful. Dr. Higgins, this will be published or is it still in press? Where are we at in terms of as people will want to get this, will want to see some of the details, tell us how they can get actually access to it.
Michelle Higgins: We've presented this at the AUA, so it is available online from that. But it's under review at a journal, so it should be published soon.
Sam Chang: Okay. All right. This is a shout-out to the editors of any of those journals. Get this thing published. People will want to use it. People will want to refer to it. Just like every ERAS protocol, individuals, institutions, health systems may tweak it in their own way, and hopefully, then be able to benefit, just as I said, patients, caregivers, and the whole health system in terms of decreasing complications, improving outcomes, and decreasing costs. Max and Michelle, thank you so much. This work is incredibly important. And as I said, once we get this published, if there are any other specific points, we'd love to have you back and go over key areas that you all may have found or focused on. I'm sure there are other questions that people want to ask, and you'll be able to glean from all the information that you all have actually built up at Hopkins. Thanks again, and we look forward to the publication.
Max Kates: Thank you, Sam.
Michelle Higgins: Thank you for having us.