Alright, we're gonna move on here and I'm gonna hand it off to who's leaving us you? Nanna? Both. Alright, you guys take a seat. But I'm starting. No. Okay, update this, update's in appendicitis management. So we had to convince Todd to put this talk. And earlier in the morning you said, didn't we talk about this already? So we'll try to convince you why we do need to keep talking about this and there's some novelty around this area. Hopefully I'll try to convince you. If not, I'm sure someone in the worldwide audience will appreciate it. Anyway, let's go with the vote. This is again, same voting as in the morning. I'll show you all patient with one day of right low court on pain. It's an uncomplicated appendicitis. Let's go straight to the voting. So the alternatives are just like a mixture of hell, no, that's just plain wrong. We should be doing surgery for everything or E, I do it routinely. Only surgery when necessary and anything in between. So this is just to get an idea of what people are doing. So what does numbers say? Don't do it routinely but have done it in selected cases. That seems to be the most common one. You're winning now. You're winning. I think one of the great advantages of this is our international colleague. So in Mexico, what are you doing? I'm not doing it. I was talking in lunch. Mexico is a tale of two tales. In private practice, no pediatric surgeon in private practice wants to do it. On the public sector, I think it would be a D. They're starting to consider and they're starting to practice it just some of them. That's exactly because of money. And because we don't think if as a whole, doctors are having a trust problem. So if you go and offer an option in the private sector, this is an option that you present to it as a viable way and when it doesn't work, which in most of the times it doesn't work, they say, oh, so he's not good. Let me go for another private practitioner. So that's a very important part of it. I think we don't need to be talking to surgeons about this particular question. We need to be talking to pediatricians and EM doctors because if there's all sorts of things that are non-opt until they need an op and then they call us, if they call us about everything that they could manage without us, that's all we would do. The ones like, oh, I do the operation because I get paid for it. Yeah, well maybe the pediatrician could talk to them or the emergency medicine doctor could talk to them. But if you need an operation, we have a subset of people who actually do that. Wait, I have a question. I want to make sure I understand what you're saying. I guarantee you, you will not get past this slide because you brought up a topic of attention. I may have misunderstood what you're saying because it's just jolted my brain. Yeah. Are you saying that theoretically these patients, we will not need to get called on them at all. Yes. Yes, I am saying that. They will be in the community. Yes. And only sent, so they don't hit, well let's make sure the surgeon agrees that we can manage the, they won't have to do that. They won't have to do that. It will be managed before it comes to it. And that's not going to be a year. That might be 10 years, 15 years. Oh, no, it's going to happen. It's going to happen. It's going to happen. And you were asking why we need to have this conversation. Okay. Are you convinced already? I am. Okay. So comment alone was huge. Yeah. Okay. That was better than a whole talk. Steven. Now we'll switch for the next two slides for Dr. Shanpipa, who will tell us a little bit about the history of these trials. So the first pilot trial that was done in Europe, Thomas Wester and Yann Spenson, they randomized a pilot study with 50 patients and 24 ended up getting antibiotics. Now two failed early on and of the remainder there were six patients who ended up getting an appendectomy. Now when we were trying to develop what our non-inferiority margin would be for the randomized trial that we talked about earlier, we really focused on those patients because only one of them had histologically proven appendicitis. The other five were abdominal pain and then there was one that was just mom preference. I felt like we needed to count all those because it's a real world situation. Sometimes mom's going to get uncomfortable even though the kid doesn't have appendicitis and say, I'm done, let's take this out. So that was where we started from and we started having the conversation about the randomized trial that I'll talk about in a second in 2013 before this study was even done and published. Then we fast forward to five years later and they ended up having only two patients, now you're already down to a smaller denominator, but only two of the remaining patients ended up getting an appendectomy in the next five years. So those failures that occurred occurred relatively early on and we saw the same thing in our trial. Then the Midwest Pediatric Surgery Consortium with ten of the centers, Kansas City excluded as we were working with the international folks on the randomized trial. The consortium did a non-randomized patient preference trial and about a third of the patients ended up selecting the antibiotics and they accrued at 1,068 patients and in that they had a 33% failure rate where patients ended up getting an operation. And like we found and like others have found, if you respond well to antibiotics it's basically like you had a little stomach fluid one day and then the next day you're fine. So there's no somatic injury that you've incurred and with the pain that was just being caused by the appendix, if cited, you're good to go. And so these patients, they have less disability days but when it works well it's zero disability days. They're good to play tomorrow. And we were randomizing with 11 other centers around the world. For a hard randomization, once you get signed up you're either going to get an appendectomy or you're going to get antibiotics. We used a computer centralized resource with the ability to tailor it so that with three different variables if you were getting further off one or the other then it ends up bringing it back to being balanced. And the difficult part was getting patients to consent for this study and it was more difficult than any trial I've been a part of because, grandma knows you need to take out the appendix. The pediatrician knows you need to take out the appendix. We pushed the education to the ED. We pushed the education out to referring EDs. We pushed the education out to the transport services so that people didn't get sold on. You got to hurry up and get your appendix out. Get to mercy and get your appendix out. And we still had a very difficult time getting patients to sign up because they didn't like the sound of recurrence. And this is something that we debate. Steve and I have had the conversation. Pete Manichee and I have had the conversation. When parents are sitting around a boardroom and they talk about what's tolerable, they say a pill versus a knife, then I could accept a 50% failure rate. When they've been up 36 hours with a sick child and now they're finally talking to a surgeon, they don't want to hear about any recurrence rate. So it wasn't those moms weren't even in the position of hearing that we have a 30% failure rate based on our data so far. They didn't get that far. Like, could it come back? Yes, it could. They wouldn't ask the question how frequently they would say, no, that's okay. We'll just go ahead and sign up for the appendectomy. So what we found was we had a total difference in 26% and we were counting negative appendectomy in the appendectomy arm as a negative result because you're not going to have a recurrence so we couldn't compare the two. That's where we had 7% patients who failed in the operative group. One patient was re-explored within a year, re-explored immediately for a hematoma. Everybody else was just a negative appendectomy. All the rest of the failures. And that's 7% against the 34% failure rate in the antibiotic arm. Yeah, we're going to skip this or any questions or comments on all that. Yeah. First of all, I like to compliment you for doing this study because so many people just parenthetically just did stuff but never studied it properly like you did. And I've been hoping to send me, I've reviewed probably 300 appendectomy studies over about 20 years for the journal pediatric surgery. So we've been looking at this forever and it's repetitively around 30% in every study over and over and over again. So I don't know why we keep asking the same question, truthfully. And so I'd like to ask you a question. If your child had appendicitis, would you go in take it out arm or the antibiotic arm? For me, I would have my kid take their appendix out. I don't want to sit around and wait for a week or a month or a year to see if it's going to recur. We have an operation that we're really good at and we do it very well and I was like, you know, what you would do. That's a great question. I think it depends on the context where you're located, who your surgeon is, your anesthesiologist. Because there's a lot more... You're tapped at it, see? No, no, I'm not. I'm not because every study, in your 300 studies, I would guarantee every study has shown non-operative management is safe. There's no... That's the key. When you're comparing things, you're comparing differences. So it's a safe alternative. And so one of the things that you can do is a patient coming from Eastern Washington and he's a four-hour transfer. I could treat that patient with antibiotics. They could stay home. We could follow him over to tell the health. I can then offer an interval appendectomy. I've just saved patient hardship, family hardship, I've saved transfer costs, I've saved all of these things. That's the... You still get your anesthesia? What about your child? What about a missed? I'll answer the question. If my son comes to my hospital with my partners and he has appendicitis and he's got a golf tournament with him the next five days, he's getting antibiotics. Otherwise, he's getting the appendectomy. Okay, so I think when you ask a black or white question, you get, well, what's the most efficacious treatment? I think this trial proved it. It is appendectomy. But while we're trying to change the question a bit here, is there a role for it? Is there a grayscale area like this 30% gap between the two treatments? Is that tolerable for some families or for the clinical situations that Stephen has pointed out? I think the answer is yes. I think another operation that we do, if we had a 30% recurrence rate that we keep on doing it. I mean, if we had a 30% recurrence rate of our hernias, somebody would send us to jail. Name it another operation that we would do, then we'd say, oh, 30% failure rate. I think that's not so bad. I think you're missing the question. What if you said it's not an operation? What if you said you can treat hernias nonoperatively and two-thirds you can avoid surgery? That's the question we have. And it's safe. What would you say to that? What would you say to those who have diverticulitis and said, let's take them out. We're 100% cure them. We can treat the majority of them nonoperatively. So it's a very different question. What if we could do all of these robotic non-skeleton? So I think that's what we're getting at. Are you saying that's non-skeleton? Are you saying, no, none of them would ever get incarcerated? None of them would ever have a complication from the hernias? 30% and we never operate on them? Is that what you're saying? I'm saying, if we've shown it's safe and that's the same thing, I think the point is it's a different end point you're looking at. You're not saying that this is an operation that is, this is 100% effective. And I think that's what we're trying to show today. I think somebody who was it that had the interesting point, of if you actually lose your indication of operation because a four days of antibiotics, how do you actually take the patient to the OR and convince the system that that's the right thing to do for the interval? For the interval, yeah. So in general, if you, when you treat them, they're better after their first dose. And what we're going to get to later on is we've shown that you can treat these as outpatients. And therefore, as we all know, even in the first randomized control trial, people change their minds. So now you're taking a pure urgent, emergent case to a pure elective. And I could schedule a patient who's hours away as a, you know, they finish their antibody course. I could schedule them in four or five weeks, six weeks, whatever it is as an elective operation. But I'm a medical director at United Health Care doctor and you can't do that. I'm not going to authorize that. I've inducted me if that parent changes their mind. I'm sorry. Next year, if you have any studies, no slides. Does your brain hurt? Yeah, appendicitis. That's it. Keep talking. Okay, let's try to get through some of these arguments. I don't think we have time for polls. But if you were to do nonoperative management, would you admit the patient or discharge from the ED? I think this is one of the benefits and I'm standing next to the senior author of the, of the article we're going to present next. So three quarters of them would admit. And I think if it's an admission for antibiotics or an admission for surgery, I think there's a very narrow gap and many people would go for an appendectomy. But what happens now if you can send a child home or had a student said we could avoid transfers. So they actually proved, this has been published this year in JPS. They screened 121 patients. They had very strict criteria. They're on the slides. And there was a 12% appendix in rate at one year. I think we don't have enough time to look at this. How many more points do you have to make? It's like six arguments. So what I'd say is for now, we do what we run out of time. Tell us what we need to know. Go through it and for each room. Okay, it is safe to send children from the emergency department. You don't need to admit them if you have strict criteria and Stephen can lead you through those criteria. No, it actually ended up only a fraction of these patients received a second dose of IV antibiotics. So two thirds actually went home from the ED and one third stayed in no differences in outcomes. So I'm fast forwarding. When we looked at which ones this is, parental preferences, parents like to be asked. They like shared decision making. And in international studies, this was from Singapore. They actually have a higher, again, not in an operative setting like you're saying, Sean, but when asked, they would actually prefer the nonoperative approach. In general, they like the discussion. And then moving on, this was so disability days. We've said it already. It is they lose less school days, parents lose less work days. How much is the gap around four days? This mid-western pediatric study found 10 versus six days. I found 10 a little bit too much for a simple appendicitis, but doctors and peders study actually found that a difference was one versus four days. So one day of disability, that's something I could totally buy in. And then the last is cost effectiveness. And what we've shown, what's been shown in a couple studies is that the nonoperative approach is more cost effective and has a higher quality of life years adjusted. So that may answer your question, Tom, about what the insurance companies or what, maybe they should trade all of them nonoperatively and then go for interval act and decommies. The real reason is that way we don't just, you know, we're not doing these in the middle of the night before, but again, we're adopting the approach that you can put off your appendectomy to the next day because you have antibiotics that can treat these patients. We can also maybe extend that saying we can push this off into weeks or later on and actually our fractional need it and becomes a pure elective operation. Oh, that's the last one. We haven't finished yet. That's one question. In the last slide, did you put the interval appendectomy in the cost? Yes. Okay. Okay. So next. So this is not for everyone. Like, if you don't want it, if you're convinced surgery, but there's also other reasons not to do it. So next slide, please. Very quickly, appendically has been demonstrated to reduce the effectiveness of nonoperative management and increase recurrence. And there's also a concern about the age. So when you reach around the age of 14, you have doubled the chance of failing nonoperative management. So I think those are two populations that maybe should not be offered this or should be offered with caution. Let's keep going. So this is the take-home. Did you want to? Should I go? Yeah. There's three minutes. I think the discussion is more interesting that the presentation itself so why don't we take it? You guys said 14, right? But isn't the adult data 30% just like just like that's exactly what I was going to say is that the Coda trial had the exact same failure rate. They had one third failure rate and that was 1400 adult patients that were randomized. So I think within the pediatric population, you might see a little bit on the subset analysis, but I wouldn't put a lot of weight on it. If we can treat 70 roles with the same results. It sounded like the, I'll stand up. The negative appendectomy rate was used as a balancing factor for those who failed on the nonoperative treatment arm. Do you think there's a role or perhaps a greater role for the patient with somewhat of a story for appendicitis, maybe an intermediate pediatric appendicitis score? Ultrasound is possible early appendicitis, let's say white counts, ERP is normal. That patient that might be a negative appendectomy if you took them to the OR, but you don't really know unless you do, is that a patient population to perhaps consider more for the nonoperative treatment? That's exactly why we suspect that some of the early case series had such a high success rate. All the randomized studies have a one third failure rate, but initially people had 90% success rates when they had very selected cases. And probably because 20% of those patients didn't have appendicitis. So that's why they got better. And just since I got the mic, I'd be remiss to say that my name is put on the top of that trial because it got moved to Kansas City for other reasons that weren't anyone's fault. But I want to shout out to Simon Eaton and Nigel Hall and Augustino Pierro with a core writing group that trial initially before I got engaged. And hopefully Simon's dealt with this. What about what happens to patients who are sent home and then for a year they wonder they get a little twins, they get a hospital, get a CT scan or ultrasound? I don't know if that's ever been enough for measure in terms of loss of work, loss of time anxiety. And I think that's part of the missing cost effective, this question. That's a more question. So that's all accounted for, like the whole disability days within one year if you're asking about the trial. But no one's saying that antibiotics is a definitive management. Like you need to screen for the symptoms for occurrence and treat the patients accordingly. Dr. With how? Quick question. So where do you all feel we will be in 20 years? What will be the norm for taking care of uncomplicated appendicitis? So Steve and myself are being led by Pete Manici who submitted PCORI grant twice now. We have yet to get funded. But we're going to be going to third round and the ultimate plan is going to be to have a funded trial to discharge these patients from the ED. And then once that's established, I suspect it Nelson's correct. You're going to start having point of contact where you're going to get an ultrasound in the pediatricians office and they'll treat it. And then the second go round they'll say you want to go downtown and talk to the surgeons. I think that's right and I think it's interesting to look at the fact that 17 years is it that takes evidence to get into change of practice. I think Todd's the key to this. I mean education and are those people that are going to be educated going to be the ED docs? They're the ones who are going to control the gate. Okay. You resisted too. I know. Yeah. You were lukewarm on it. It's almost like we need a whole. Yeah.
Click "Show Transcript" to view the full transcription (20519 characters)
Comments