Episode 5-journalSBvKH

Episode 5-journalSBvKH

[00:00:00] Hello and welcome to another episode of Behind the Knife with the hernia team at Cleveland Clinic. I'm Sarah here with Mike Rosen and Clayton Petro. Today we're reviewing our group's recently published randomized control trial open retromuscular sugar baker versus keyhole mesh placement for peristomal hernia repair.

To briefly summarize the trial, this was a single center, parallel arm superiority trial that compared open peristomal hernia repairs with permanent synthetic mesh placed in either a retromuscular sugar baker or a retromuscular keyhole mesh configuration. And our primary outcome was peristomal hernia recurrence at two years.

So, can one of you please tell us what inspired you to address this question in a trial? Sure. Well, first of all, thank you for having us on to discuss this. This is a lot of work. There's five years, three years of enrolling patients and two years of follow up. So certainly a lot of work went in this and it's we appreciate the opportunity to get to sit down and talk about it.

So, you know, in surgery when there's a new [00:01:00] technique, I think the retromuscular sugar baker technique is relatively new. When, when there's a new technique, I think there's always a lot of up front excitement. And when you look at some early data, obviously, you know, there were some optimistic findings in terms of reducing recurrence rates.

And we had some of our own retrospective data that showed as much as a 20 percent reduction, 30 to 10%. And that's a huge signal and if something is that significant from a research perspective, we get really excited because from, you know, in the terms of designing trials, you can start to do a trial in a relatively reasonable amount of time when there's that much of a difference.

You can power a trial appropriately to, you know, find that difference in a randomized fashion. So, we thought not only would it be important to the literature to show that there actually was that much of a benefit, but if there is that much of a difference, then it's also feasible as well. So, I'll tag on a little bit to that.

I think like almost all clinical trials that we've done here our kind of impetus behind doing it is [00:02:00] because we thought we figured out the answer. And we were excited to prove that we knew what the best technique was. And, and I think that, you know, if you look at the trial design and you look at kind of our historic data, You know, everything in hernia, particularly with peristomal hernias, like, like Clayton said, there's initial excitement.

That excitement spurred us on to look at this in a rigorous, scientific way. And I'm sure as we'll get to like most clinical trials, we proved ourselves wrong. Can you please, before we move on to describe more of the trial, just briefly describe the difference between a sugar baker and a keyhole?

Sure. So, you know, in a modern retromuscular hernia, ventral hernia repair, there's three layers. There's a posterior sheath or peritoneum layer that gets closed, we lay a piece of mesh on top, and then we close the muscle on top of that. And so at the end of the operation, you have to bring a piece of bowel through the abdominal wall.

You have to bring it through all three layers. A keyhole technique makes the hole in all three layers line up in a straight line. And [00:03:00] in a retromuscular sugar baker technique, the bowel comes through the peritoneum drapes on top of the mesh, and goes through the muscle, and is in kind of offset holes.

So the holes are kind of offset from one another, and it creates a bowel effect. So, typically the posterior sheath hole is more lateral than the anterior sheath is? Yes, typically. It doesn't have to necessarily be lateral, it can be any direction that's offset from where the anterior hole in the muscle is.

Okay. We had previously published the short term safety outcomes in surgery, and those are 90 day outcomes. That actually showed that there was pretty significant wound morbidity in both groups, but there was no significant difference. We had about a 16 percent SSOPI, or surgical site occurrence requiring some kind of procedural inven intervention rate, but then again, there was no differences between the Sugar Baker and Keyhole arm.

We did have a few re operations in the Sugar Baker arm that we felt were related to the technical complications, but at that point, we were still [00:04:00] waiting to see the data on the long term peristoma recurrence, which is what was published in JAMA Surgery. Yeah, I mean, I think first of all, you know, anytime you take on, I would say, all retromuscular surgery, the technical challenges of retromuscular surgery are significant, and we've certainly learned over the past decade, as it's become more and more accepted, that these are challenging operations.

And when you add a stoma, and some of the things that Clayton mentioned, Not just the dissection of that, but also the architecture and the arranging of everything under tension, without making it too tight, without kinking it too far. These are very, very challenging operations. And I think that's probably one of the biggest take home messages.

from this trial is, you know, I would say we're a fairly high volume center, you know, 150 patients randomized for peristomals, I think might be the biggest trial ever done for peristomals. And so even in our hands, folks who do this [00:05:00] stuff fairly frequently, the morbidity is real. And so I think just taking a step back and realizing and kind of talking with patients about, you know, these different approaches, you know, the sugar baker, there is an upfront price to pay.

Of, of getting this all angulated, and I think one of the keys to a sugar baker is just realizing, as Clayton described it, that this is a, kind of a balancing act between enough offsetting, without excessive kinking. And I think clay and I have both done a lot of these and I think you know, we both agree That's much more art than it is science and it's very difficult to describe to folks kind of where that magic line is and in this trial at times we Probably pushed it too far And and at times maybe we didn't push it far enough.

And so I think that's the kind of subtle technical aspects of these operations You [00:06:00] that everybody needs to kind of take it with a grain of salt. And, and this is one of the things about trials being done in high volume centers. You know, a lot of times you take technique off the table, but I think that this highlights that even in a high volume center, technique was still challenging.

And there were technical complications. These are difficult operations. Yeah, these are, these were humbling cases. I think just looking morbidity by itself, you know, the 16 percent wound morbidity, that That is just a reflection of these being really challenging, you know, contaminated cases of abominable wall reconstructions.

So, and then I think, you know, like you alluded to, the recurrence component of this is so important because if, if, you know, if the sugar baker technique really does reduce the recurrence rates by that much, then it might be worth adding a little extra tension, trying to get the holes a little more offset.

And you might, you might accept some of those potential You know, rare mesh related complications at the stoma site if you were giving, you know, a huge benefit on the [00:07:00] back end in terms of reducing recurrence rates. And so, the value of the operation was really going to require both the peristomal mesh complications and the recurrence data so that you can kind of sit down at the end and, you know, make an educated decision about what's best.

Okay let's get a little bit more into how we designed the trial. So as we mentioned, this was a single center trial at our high volume center. We had blinded patients and assessors. In terms of inclusion criteria, patients had to have a permanent stoma, or they had to be undergoing a permanent stoma creation in the setting of an existing hernia.

And they had to be a candidate for an open retromuscular peristomal repair. We excluded patients who had two stomas preoperatively, or if intraoperatively they were deemed to have insufficient bowel length to be randomized, or if mesh placement was not safe at the time of surgery. So randomization occurred intraoperatively.

the patient was deemed to have adequate bowel length for either technique. And we powered [00:08:00] this to detect a 20 percent absolute reduction in peristomal hernia recurrence at 2 years. So can you talk to us a little bit about how we defined recurrence? Because I think that might be confusing. So this was really challenging because there actually is no standardized way that, that we can all agree upon in terms of, You know, what is, how do you define a peristomal hernia recurrence?

And so, certainly on CT scans, sometimes it might, you know, even though the patient feels a bulge, you can look at a CT scan and it doesn't necessarily look like there's a recurrence. And so we had to kind of decide amongst ourselves what we were going to call a recurrence. And what we decided upon was since the most clinically significant recurrences would be those that had a separate loop of bowel that was going through the aperture, that that would potentially be able to cause an obstruction, we decided that that would be what we would call a recurrence.

And there's actually a classification system that we cite in the paper and that had previously been defined as the Merino Matthias classification system, and I, I believe it was a class three or class four. Yeah. Yeah. So we just, [00:09:00] we landed on that. As what we would call a recurrence. So I'll add a couple things, maybe not quite answering the question that you asked, but you brought it up in the, kind of, how we powered the study.

And how it came up, because I think that that has to be brought into, you know, that is an often underrated, incredibly important aspect of any clinical trial. Is, kind of, where you set the goalposts, and the differences, and how many patients you need to do that. And, you know, always comes into, are you underpowered?

Is, did you really not find a difference, but there might have been a difference, and so, and, and, it's important to look at that in the space of recurrence, and, and you had mentioned, you know, we powered this study off of a prior study that we had done looking at biologic and synthetic mesh, and we had done a post hoc analysis of sugar baker versus keyhole, and it was actually a two year follow up, And it was 30 percent in the keyhole and 10 percent in the [00:10:00] sugar baker.

And you know, at the time, and those were anatomic recurrences, just like here. At the time, you know, there was a lot of excitement. And I think it's important to realize when we talk about, well, are we underpowered? Nobody really questioned that difference. Like, and I think clinically in the world today, that's what most people think a sugar baker probably does.

There's not a lot of published data out there about sugar bakers, particularly retromuscular sugar bakers. But I, I think that using that data to power this, you know, we expect it to find a 20 percent difference. And I think you know, most surgeons who are doing sugar bakers think that there is a significant reduction in recurrence rate.

And so, I stand by that, but also acknowledge that we might have been underpowered to notice a small difference. But, but I always kind of revert back to, you know, if you're not doing 75 peristomals in your life, if it takes us a thousand patients to find a difference, is that a clinically relevant difference?

Clayton, what do you think [00:11:00] about that? So I've thought about this a lot, because clearly if nothing else, the retromuscular sugar baker appears to at least delay the recurrence of the first year. And then by the second year, they're much closer, certainly not what we powered it to be, but still a difference.

And so let's imagine a world where we had You know, seven or eight hundred patients, and we randomized them, and there was still the same difference, but now we have a different P value. You still are left to reconcile, okay, is it worth pursuing that technique? And at the end of the day, let's say that there's a seven percent difference at two years, which is what we found.

And let's say that even in a larger set of patients, it's the same difference, only now you have a significant P value. I think it's, there's kind of something here for everybody. I think if you have a patient with favorable anatomy, and you're a skilled surgeon who's done a lot of these, Of course you're going to give the patient the delayed recurrence or the chance of, you know, a lower chance of getting a recurrence in two years.

If you're someone who the anatomy is not favorable, you've not, you have not done a bunch of these, then you can rest assured that it's really [00:12:00] not that much of a difference. That you're not really withholding some great thing and you're not going to maybe try to overdo it and set the patient up for a, for a mesh complication at the stoma site just because you tried to force it.

So I really think no matter kind of which end of the spectrum you're on, in terms of being, you know, a four against this operation, there's kind of something there for everybody. Let me ask Clayton a follow up on that. So if, so, although we didn't study this, but you have a lot of experience, we've looked at a lot of CT scans together, and so, what do you think the difference is in the mechanism of recurrence that we've learned from this trial that people can take from and try and apply?

The best approach that we understand for the right hernia, and I want to make one quick caveat before you answer this, because we didn't mention this, but it is important to discuss all these patients almost exclusively had large midline hernias as well. And just, I want to put out there before you answer it that we do think that there is a space [00:13:00] for minimally invasive surgery for stomas.

It's not in these patients because they have large midline defects. So the isolated Parastomal defect after a lab APR, a robotic APR is not addressed in here and the kind of dilemma between robotic or lab IPOM, SugarBaker versus Keel, we have not addressed. But what do you think about the difference?

So, I, just personally from looking at my, my per, like SugarBakers that recur, cause sometimes you, you think about SugarBaker and there's all that overlap and the perfect SugarBaker you've got, you know, maybe 10 or 15 centimeters of offset. How could that possibly recur? And the ones that, At least that I've noticed are the ones where you're taking the ilium and you're trying to put it on the left side or maybe the transverse colon and you're trying to put the stoma on the left side just because that's where the patient wants it or that's the most favorable place to put it.

And when the mesentery seems to pull the posterior part away, it seems like whatever offset you have, when the tension is on the [00:14:00] posterior sheath pulling that, that, that what you think is a lateral aperture, Back to the middle, then the holes just start to line up again, just like a keyhole. That, that's the ones that I've seen.

And what about keyhole, because it's interesting, when you look at the keyhole, Yeah. It came early, Yeah. And then it kind of stopped. Yeah, so the keyholes, probably, that has a lot to do with how tight you make the aperture. And so that, really, since, those seem like, if they're going to recur, they're going to recur right away.

And so why would that be? It's probably, probably more technical in terms of you just didn't make the, the aperture tight enough. Yeah. How tight do you make it? Yeah, how do you know? Who knows? I mean, like, that's unknowable. I really, you know, I don't know. And sometimes I will, you know, sometimes you have to make it large enough to get a bulky mesentery through it.

But then wherever it sits might be a little thinner. And so I've been I even sometimes I'll throw a stitch just to make it a little more stug, snug after I'm done. Yeah, I mean, I, so I think that. There is like a hammock [00:15:00] effect for sugar bakers, right? And then there is also a fear of keeping mesh too close to the bowel.

And there's one thing we didn't mention, in this trial, I think it's in the paper, I can't remember the exact numbers, maybe you guys do, but we had pretty much abandoned transfascial fixation sutures. And I think that at least our feeling on this is that by abandoning the transfascial sutures, we abandoned kind of the guillotine effect.

And to my knowledge, we didn't have any erosions with the keyholes, did we? But we have had that in the past. And so, at least we think today, avoiding any transvascular fixation allows the mess to lay and we make the, and I think the keyhole, one of the tricks is to, I don't know how to say it either, but other than to make it uncomfortably tight.

If it's an ileal conduit, just urine has to get through it. If it's, you know, a colostomy, I like it to lie up on there, and I agree with Clayton, I'll bring it back in. And I think for a sugar baker, this is one of the things you have to be able to judge. Like, I think there are times you can get incredible lateral [00:16:00] coverage, but when you can't, it might be an inferior operation.

We'll go back and pull out all these things and look at all this stuff, but I think that's our kind of 30, 000 foot view of it, too. We've kind of alluded to a lot of the results, but just to go over it for completion's sake we had 150 patients enrolled in the trial, 75 in each arm. We got about 91 percent follow up at two years, which was excellent.

Baseline characteristics were similar between the patients and most operative characteristics were also similar except for a few things that were technically different between Sugarbaker and Keyhole. So I think that one of the biggest criticisms of the trial is that in the Keyhole group, and I'm going to try to go through this slowly, in the Keyhole group, the stomas were more likely to be recited.

And the reason is, is that most of us doing these here, if we get randomized to a keyhole technique, we would prefer to bring the stoma down and bring it through a cruciate incision rather than slit the mesh and [00:17:00] have to sew it back up around it. Now what that means is if you take the stoma down, the stoma is more likely to be re recited in a new location.

And so when you do that, you're now you know, creating prophylactic reinforcement around that stoma, rather than compare that to a sugar baker where one of the biggest advantages of that technique and the supporters of it are that you don't have to take the stoma down because you don't have to worry about bringing the bowel through a piece through a hole in the mesh.

And so you, you can leave the stoma where it is. And that, you know, is a different, philosophical assessment of that stoma site because the stoma, peristomal hernia, was there. You're fixing it without moving it and you're reinforcing it as opposed to one you take down and put in a new spot. And so that difference in prophylactic reinforcement versus fixing the stoma site was inherent to which arm you got randomized to.

Now obviously that was going to confound the [00:18:00] results. And so we knew that that was going to happen, and we, you know, planned ahead of time to look if reciting the stoma mattered, and that did not seem to. But just recognize that, that, you know, that if you think that you are putting the sugar baker at a disadvantage by allowing the keyhole folks to get recited, just recognize that proponents of the retromuscular sugar baker technique often cite not needing to move the stoma.

As an advantage. So it can't be both. It has to be either an advantage or a disadvantage. Because if you think that the sugar baker being able to keep it where it is is a disadvantage, well then you should be taking it down and moving it, so. And I would just add, I think this is one of the things, and we've done a lot of this work, and our group has, around trying to design randomized controlled trials with the background noise of complex abdominal wall reconstruction.

And I think that. As Clayton mentioned, there's a trade off to this and these really should be considered [00:19:00] pragmatic trials in that we cannot force surgeons to do certain technical things because the situation does not allow for it or suggest it's the appropriate thing to do. And so again, I think, to me, at the end of the day, when you look at it, there is a piece of bowel going through a mesh, either straight or with a gradual S configuration.

And ultimately, that's what we're after. And, and I think that the kind of excitement around the retromuscular sugar baker has been such that it was the fix for peristalsis. I mean, I, and just to be clear, that's what we thought we were going to see. Like, we didn't think this was going to be even close to not different.

And at the day, by waiting it out, getting long enough follow up, lo and behold Like, this is a hard operation, and we haven't found the magic bullet yet. [00:20:00] So we also know that parasomal recurrence at one year was significantly different. It was lower in the sugar baker arm at about 8 percent versus 21 percent in the keyhole arm, which is kind of interesting because the idea of the prophylactic mesh is that you should slow, you should delay recurrences.

It doesn't really seem to have had that effect in this population. But by two years, there was no difference between the sugar baker and the keyhole arm. a 17 percent recurrence for sugar baker versus 24 in the keyhole arm, and that difference persisted even after we did adjusted analysis for all of those features that we thought would affect recurrence rate.

So what do you do with this information now clinically? So yeah, I think it's it's like I said before, I think that if you have the skill set and you have favorable anatomy, I think there's still a benefit to trying to pursue. a retromuscular sugar baker. That's kind of my go to. However, now I have a little bit of peace of mind that if the [00:21:00] anatomy is not favorable, and if I feel like I'm forcing it, I'm not going to put myself in a situation where I'm going to put a lot of tension on the bowel, and potentially cause a mesh erosion just because I'm trying to, you know, do a retromuscular sugar baker.

It's not worth it, and I can have the peace of mind that I'm not giving the patient too much of an inferior operation. So I would say for me I use it a couple ways. I start with in my patient kind of discussion when folks come in with peristomal hernias and I say, you know, listen, we know roughly about one in five are going to come back.

That's substantially higher with radiographic recurrence than our typical hernia repair. So that's my first discussion is, you know, unless you're really symptomatic, meaning your bag's not fitting, you're having obstruction, you're having pain, leakage, whatever. And I, I try and discourage people from having this done.

And I kind of look at it, I look at this like I do most hernias now. It's a little bit like orthopedic surgery, right? Like, orthopedic surgeons try and hold off you getting your hips and [00:22:00] knees done until as long as possible. Inevitably, you're probably going to need it, but the operations don't last forever.

They have a high recurrence rate, it's a high mechanical load, and you add a stoma, it's even worse. So I think, number one, again, I, I think 20 percent is a pretty good recurrence rate, to be honest. But it's still 1 in 5 and it's higher than a normal hernia, so I, I have that conversation with the patients right up front.

And then number 2, and, and I really, you know, I want to agree with what Clayton said too is that It, it really gives me a little bit more confidence to do a keyhole, but keep the hole tight. And again, we haven't measured the hole and done all that, but I think that what you see with the keyhole and the pattern of recurrence with the keyhole.

I think it is that the hole is too big, early recurrences. If the hole is not too big, and it scars in, the recurrence rate really levels off. So, again, I will have a low threshold to do a keyhole, but I would also agree with Clayton. Kind of [00:23:00] my preference is if the bowel is really able to lateralize, and you can judge that, then I do like, a retromuscular sugar baker.

What do you think is the next step to try and address the problem of parasomal hernia recurrence? Well, honestly, so if you look at this from the perspective, okay, you know, we thought we had the magic bullet. We don't. It does seem like a significant proportion of these come back no matter what. It does make you kind of circle back and go, okay, I know I'm going to be fixing these again a lot of the time.

And coming from a place that, I mean, we use almost exclusively synthetic mesh here. And for these peristalses, it's medium weight polypropylene. piece of biological biosynthetic and Mike finished his biological synthetic trial years ago. But if, you know, it does make you kind of circle back and go, okay, if I know that there's a lot of these that aren't going to be coming back, if I have to be doing redo retromuscular peristomal hernia surgery, are these the patients who should be getting, you know, biological biosynthetic mesh?

[00:24:00] And I'm not, I'm not a, you know, I don't get paid by any of these companies, but I do think it's at least worth a consideration. Yeah, I mean I think, look, there's a bunch of unanswered questions, right? And I mean, the questions come down to what can we do with the patients, what can we do with the mesh, and what can we do with the technique, right?

That's where the answer to the majority of our problems are. I think from a patient perspective, there's not much you can do, I mean they have a stoma. From the mesh, I agree with Clayton, there's a lot of unanswered questions. to kind of support Clayton's comment about this. The, the study that we powered this off of, the biologic versus synthetic, there was no difference in the peristomal recurrence rate.

The only issue, which is the challenge, is a lot of these people had midline hernias, and there was a difference in the midline hernias, meaning that the synthetic was better in the midline, but they were equally as bad at the stoma site. And so, I, I [00:25:00] think all of this weighs into making those decisions. I kind of more rely on, or think about, There might be more technical modifications and kind of my never ending effort to do less peristomals and get my partner Dr.

Clayton Petro to do them, I want to let you guys know about what I think is maybe the best modification. We call it a key baker, but I also refer to it as a Petro peristomal hernia repair. And that basically, I think if you think about what Clayton said, it takes the best of both worlds, right? Is if you think about the hammock effect of a sugar baker, meaning that you kind of push the mesh off to the side and there's almost like a turtleneck bunching up around the stoma.

We've done, and we're actually looking at the data right now, I think we've done about 75 and we'll wait until two year follow up now that we know this. But this operation is essentially a sugar baker, but then you perform, so it's a sugar baker at the hole [00:26:00] through the rectus muscle. And then it is a keyhole, as the stoma goes through the posterior sheath, so it combines, so now you've wrapped the mesh out laterally, and you can either do it as a cruciate, or you can do it as a, as a lateral slit and wrap the tails around.

And again, to me what that does is it gets the mesh out laterally, it might decrease the hammock effect, but again, to be completely honest, like, we need two year radiographic follow up in 75 patients, and see whether this is the answer. I'm sure it won't be. The whole answer, but I think that, you know, my feeling is at least my recurrences were kind of not getting it lateral enough and just the inherent weakness of a sugar baker that you just don't have mesh lateral to the stoma.

So I think, I think this key baker concept is, is exciting and new and we'll have to track that and see what happens. Again, we'll never find the answer, but hopefully we'll keep getting better and better. Please don't [00:27:00] ever call it a PTO. Wait 10 years and then we can do it. When we all find out it's a bad idea.

Yeah, my luck it'll cause like, it'll cause erosions. One other thing that I kind of just wanted to talk about is, we've already talked about that we had a lot of midline hernias and they were very complex. Our average defect was 15 to 16 centimeters between the groups. So I think we didn't really address what to do with an isolated pair of stoma.

Because maybe it shouldn't be that we jump to a retromuscular surgery for those isolated peristomals. Maybe a minimally invasive is better to keep that plane for the future. Yes, I feel pretty, I feel pretty strongly about this. I, I think we've gone through the phase of the, you know, everyone wants their video of an ETEP you know, unilateral tar doing a sugar baker and, and and that's great.

It's a cool operation. But I just, I think, when you start thinking, even when I do these open If I can spare the TAR plane on one side, because I know, in the [00:28:00] back of my mind, I'm thinking, Ugh, you know, 20 percent of the time I'm going to be back here in the future. I got, you know, 25 years of career left. I have to plan for the future.

So, I, I do think we should, you know, violating these planes in a minimally invasive fashion should be done thoughtfully, and I think there's nothing wrong. One of my favorite robotic operations is a robotic intraperitoneal measure. I think, I think that's like one of the best uses of the robot because it kind of lets you set the tension of the mesh to get the, the holes offset.

And so I, I think intraperitoneal eye palm sugar baker is a great operation. And I would definitely advocate for that over some of the, you know, some of the retromuscular techniques. Yeah, I would just tag on to that. I think Importantly, we kind of touched on this before, but just to reiterate it, is our data does not address that question.

Right? Like, we don't know that. I think that should be put to a multi center, randomized control trial. Because I think it's an important question of Keyhole versus SugarBaker. I agree, minimally [00:29:00] invasive. Retromuscular peristomal hernias, it's, it's not worth it. You still, you know, you, you just, if everybody just steps back, at least the purported advantage of minimally invasive retromuscular surgery is to keep the bowel off the mesh.

But in a peristomal hernia, there must be bowel on the mesh if you're doing a sugar baker. So the operation will not afford that. So to go in there and violate that plan, make it much, much more challenging, It really makes no sense and I agree with Clayton, I think that's the sweet spot of the robot. I think you can so much more elegantly close the defect.

It's hard to do that with the Carter Thompson and while you can sew it lap, it's much, much harder and I think being able to position the mesh just the way you want it. So I, and the other thing is the majority of these cases are either a robotic or lap APR or robotic total colectomy or lap total colectomy with an end ileostomy.

Both of those set up nicely for a sugar breaker to the right, a sugar breaker [00:30:00] to the left, and doing it minimally invasively makes sense. For me, if they have a midline hernia, I think it's just, it's too much with the mesh. It's not wrong to do it minimally invasively, but it's a little bit much, so. So, the midline hernia to me is going to take us to open, and the isolated ones, I think MIS is a great approach for the right patient.

Yeah, I mean, my final comment about this is I think like, you know, look, like when all trials come out, there's an initial like, Oh my God, how can this not prove my bias, right? And I think that we would be remiss if we all didn't say that we have those feelings before we write these papers, right? And so, we wanted to have a winner.

Like, that's, we take care of these patients every day. We want something to win. We want it to be an easy answer. But the one thing I think we've all learned from all these trials is the answer is often not easy. And it's confusing, and it's complicated, and there's bias, and there's confounders. But, but I think that to me, the biggest take home point for this is, [00:31:00] everybody in the abdominal wall reconstruction community take a deep breath, and realize that peristomal hernia repairs are challenging, they're complex, their results are not perfect, and sometimes doing the operations you feel most comfortable with is perfectly appropriate for the patient, and you don't need to push it.

into more advanced things that could potentially get you in trouble and irreversible things, particularly when they fail. Yeah, I think the only other thing that I would add is, you know, follow your own outcomes, too. You know, if you're getting really good outcomes with keyholes, you know, why would you change?

And if you feel like you're getting, you know, even better results than we are with your sugar bakers, then again, you know, that supports whatever you're doing. So I think that, you know, You know, there might be variability, surgeon to surgeon. There's so many subtle, technical things in these operations that we, that we talked about.

The tightness of the keyhole aperture. You know, how good you are at offsetting the holes in the anterior and the posterior sheath. There's [00:32:00] gonna be some variability, surgeon to surgeon. And so, follow your own outcomes and if, you know, whatever you are doing that works, keep doing that. Thank you to Dr.

Petro and to Dr. Rosen for sitting down with me and talking through this trial. And from all of us at the hernia team at Cleveland Clinic, dominate the day.

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