Timothy Donahue: Yeah.
Sam Chang: ... spending some time with us and look forward to hearing your recap of what you all were able to accomplish in New York City.
Timothy Donahue: Sure. Thank you very much for inviting us on to be able to talk about this. So this project is interesting. I'm going to give you a little bit of background and then talk about the project itself. When I came to Memorial as a fellow, I had already been an attending independently for about 10, 12 years. And I had been doing cystectomies and I saw these parastomal hernias. And Bernie Bochner and I were talking a bit about it. And so, one of the first things we wanted to do was sort of look at how common these are. And so we did our own sort of investigation. We looked at about 500 cystectomies consecutively. And we saw that the parastomal hernia rate was about 45% at three years and beyond. And it was easily 25% at a year out. And those were radiographic hernias. In terms of symptomatic hernias, clinically apparent hernias wasn't necessarily as much. But one of the things that we started looking at was risk factors because we wanted to see was there a way that we could sort of prevent this. So who could we pick or find out?
And so we did an analysis very similar to what some other folks did. So Nick Liu, who had been one of our fellows at Memorial when he was at Indiana as a resident, he did an analysis of their experience. We had very similar findings, higher BMI, low albumin at the time of surgery, women. And in fact, I think others have shown the same thing. There was a paper out of MD Anderson around the same time. So this prompted us to look at the literature, and it was actually the colorectal literature that prompted us to think about, is there a way that we could do this? And interestingly, they had a number of randomized trials of mesh placement at the time of end colostomy or ileostomy to see if they could prevent parastomal hernias. And so a lot of this came out of Sweden and we started trying to mirror what they were doing there, but we were very worried because we have both an enteric anastomosis as well as a ureteroenteric anastomosis. And we were wondering if the risk factors were going to be different with the urine leak that sometimes happens. It's not an end colostomy, and so the conduit can shift in a different way. And so after we had identified a risk group, we decided to do a safety trial. And we looked at 65 consecutive patients having mesh placed, and we wanted to see were their radiographic hernias less than historic rates. And the reason we picked radiographic hernias was because it was quantifiable.
We also, interestingly enough, found when we looked at our initial series of a little under 500, for those that did develop a parastomal hernia, there was a progression rate. So sometimes they were small, got a little bit bigger, a little bit bigger, a little bit bigger. And what we found was once you had this type-two parastomal hernia where you had fat bulging through, the likelihood of progressing onto a clinical symptomatic hernia was well above 50%. And so that's why we picked radiographic hernias because it was the easiest to measure. And we'll come back to this later when we talk about what could we do even though this was a negative trial. So we had this safety trial, 65 people, and we reduced the radiographic parastomal hernia rate by 50% at two years. And so we were very enthusiastic about this and started up a trial. And we got going around 2018. Then COVID came in and there was a little bit of a delay, but we were able to do this randomized trial in patients undergoing cystectomy. Now what we did was we broadened it out. So we didn't just have that high-risk population like we did in our safety sort of pilot study and trial. And that was a group of BMIs above 30, low albumin and women because they had the highest risk.
And we only wanted to subject people we thought who were at highest risk for hernia to the risk of mesh placement. Interestingly, in that 65, we had no mesh-related complications. And I think that was very telling. And it's also telling when we get to our randomized trial where we had 165 patients. And again, we only had one mesh-related complication and that was somebody who flew into town, got surgery, went back to Florida, was having some issues. We asked them to come back. They couldn't for a variety of reasons, eventually did. And there was a little bit of a delay in managing what was probably an infected seroma. But that was it. But for the folks that were nearby, no mesh-related complications, and still to this date. And so we have data going back to 2016 on prophylactic mesh placement in the trials and then our randomized trial. So we started this randomized trial looking at the reduction in all comers, so men, women, regardless of BMI. And about 80 something patients in each group done by a number of the surgeons here. Unfortunately, as you pointed out, it was a negative trial. We did not see an improvement in outcomes with respect to radiographic hernias. Similar to what the team at USC saw, they used a different type of mesh.
We used a semi-absorbable mesh, which was a Vicryl mesh and then Prolene. And so the Vicryl would reabsorb over time, the Prolene would stay, and that's what they used in the colorectal trials in Europe. Similar to also the study done in Scandinavia, which also trended towards a reduction in hernia rates, but their trial was also negative. And what I can't really explain is why the urologic randomized trials were negative, and yet we have probably a half dozen colorectal trials which showed a positive benefit. Now, at the same time, there were three or four negative colorectal parastomal prevention trials. So it's not universally recognized that I think that they're better surgeons. I don't know. They may be more familiar with hernia repairs, some of these placements, and there may be some technique issues. But unfortunately, we did not see an issue. I think when we look at lessons learned from this trial, I think the first is that mesh was safe. We saw no adverse events that we could correlate to the placement of mesh. We looked at complications, all complications. They were essentially equivalent across both groups. So we didn't see anything that we could relate to the mesh. And in terms of one operative intervention for someone who was a bit of an outlier and due to a variety of factors.
I think the next thing that we took a look at was what about clinical symptomatic hernias. Interestingly enough, when we go back to our original experience of looking at 500 folks and how often acute interventions need to be made, and then over the last 10 years of following these folks very closely. Interestingly enough, in a group of about 800 patients, we've seen eight people in that entire period of time who've had to have emergent surgery for their parastomal hernia. Four of those were folks who counted in that group mainly because they had automobile accidents and they were getting X laps anyway. Now, I don't know if there was something that worsened because of the motor vehicle accident.
Sam Chang: Sure. Yeah.
Timothy Donahue: We have four strangulated hernias out of a series of watching about 800 patients over a decade. So I think while we worry about parastomal hernias being a problem in terms of how dangerous are these, they're rarely dangerous. So I think less than 1% of patients that get these long-term are going to need some acute intervention. Now, roughly 50% of patients do get these radiographic hernias. It's probably about 25% are clinically, truly symptomatic where they have trouble with the appliance, bothersome bulge-
Sam Chang: Yeah. Disfigurement.
Timothy Donahue: ... difficulty with drainage.
Sam Chang: Right.
Timothy Donahue: Yeah. And then to your question of how do you prevent this? Well, one of the things that I wonder is, and I don't know that this study will ever be done, but we did see a significant improvement in our parastomal hernia rate in that select group of highest risk patients. I think that if you could identify a smaller risk group in whom select placement is done, there could be a benefit. And who is that? Well, I think people with higher BMIs, it does make a difference. The low albumin as an analysis, that's tough. They're going through neoadjuvant therapy.
Sam Chang: Yeah.
Timothy Donahue: They're older and frail. I think people with small abdominal walls for musculature, like some women just don't have that robust rectus, there may be a benefit there as well.
Sam Chang: No, I think those are some really important points that you made, Tim, that you highlighted. The prevalence of this is quite high. The symptomatic prevalence is lower, if you go back to the historical literature, people talk about a 10 to 15% rate. I think that's horse whatever. It happens much more often than people claim. The prevention, it's obviously we as a urologic community have struggled with, we do everything we can to try to prevent. We do these different techniques. We've now tried to use mesh in different studies, haven't shown a real benefit. I just want to ask a couple questions kind of pre, kind of during the surgery, and then what you all now do at Memorial afterward. Okay. So did you notice any difference in terms of the technique of actually doing your stoma? So people talk about incorporating the fascia with their stoma and tacking it. They talk about different suture bites, intraabdominal, and then a super fascial. Does everybody do the stoma the same way at Memorial and did you see any influence on that?
Timothy Donahue: So the answer is not everybody does the same stoma exactly. Dr. Bochner likes doing turnbulls.
Sam Chang: Yeah.
Timothy Donahue: That's his preferred diversion type. The rest of us almost exclusively do end stomas. I stopped placing fascial sutures between the wall of the conduit at the fascia. And that was based upon, one, talking with Dr. Delbani and he had stopped doing it. Dr. Donat had as well. And if Machele stops doing something, then there's probably a good reason. And then what I can't explain is the team at Anderson had published a study looking at that issue and the mechanism couldn't be explained, but they published a series showing that placing those fascial sutures seemed to increase the risk of parastomal hernia, which intuitively doesn't make much sense to me. But I didn't have a lot of reason to place them, so I stopped. Now, for the turnbull, we'll sometimes secure the afferent limb below so that there's not prolapse in that manner, but no, I think we're all doing it pretty much the same way.
Sam Chang: Okay. So some key takeaway points there. And I think, just as anything, we're all influenced by our training and our experience. But you have a trial that shows placing those sutures may actually increase the chance of hernia.
Timothy Donahue: Yes.
Sam Chang: You have leaders in the field that don't place fascial sutures and haven't noticed a significant difference either way.
Timothy Donahue: Yeah.
Sam Chang: In all honesty, I don't. I haven't for 20 plus years.
Timothy Donahue: Yeah.
Sam Chang: And I have partners all around me who still do, who swear by it. So I think clearly an area of probably unknown, but I definitely don't think it's a necessary step.
Timothy Donahue: Yeah.
Sam Chang: And like anything, I support those that support our practice or my practice. So this is great to hear. So I appreciate that. And I do think that's important. This radiographic hernia now to possible progression, et cetera.
Timothy Donahue: Yeah.
Sam Chang: What we do with that, now that's my last kind of final up is we don't seem to do a good job of preventing these. So now we have them. And I think the vast majority, and tell me if you agree or disagree, with early radiographic, we do nothing. And that's been our practice.
Timothy Donahue: Yeah.
Sam Chang: Now, if they start progressing, I think the tip off for us has been clinically significant, bothersome.
Timothy Donahue: Yeah.
Sam Chang: So if someone can't pouch, if it's disfiguring, if they're having trouble draining because of angulation or that type of thing, I think we fix. What we have done at Vanderbilt is we actually incorporate our hernia surgeons. And the vast majority of them now do this laparoscopically or robotically.
Timothy Donahue: Yeah.
Sam Chang: And I've stuck my head and watched, we're always available because if there's any questions, they'll have us inspect the conduit or perhaps even the anastomosis. But they do a wonderful job. What I've learned is, it can be successful.
Timothy Donahue: Yep.
Sam Chang: That probably the majority of time it's successful, but it's not 95% that don't get a hernia. I mean, there are definitely recurrent hernias after even these beautiful hernia repairs. And so it definitely, they seem to support the fact that once you have a hernia, unfortunately you're at higher risk to have another hernia. Tell me what you all do at Memorial now post hernia, clinically significant development. How do you all fix them?
Timothy Donahue: Yeah.
Sam Chang: Who fixes them? What do you all do?
Timothy Donahue: Yeah. So I think that we follow a very similar algorithm. Not every hernia needs to be addressed. If I see them beginning to enlarge or become symptomatic like you're talking about, we'll have the hernia surgeons involved. We also find that this is typically done either through some minimally invasive approach, mostly robotic-assisted these days. And one of us is generally available on that day to assist. If it's complicated, there's any issues we're certainly scrubbing in.
Sam Chang: Yes.
Timothy Donahue: And I've found that at a minimum, the bother has been reduced. The risk of clinically worrisome hernia has been addressed with that. Not all of them have a complete response, but it's generally better.
Sam Chang: Yeah, no, agreed. Very much agree. Well, Tim, thanks for all the efforts that you all have done at Memorial to evaluate this process. I think helping us make more aware. Don't feel down in the dumps in terms of a parastomal.
Timothy Donahue: Yeah
Sam Chang: It happens and understanding that it's one of those complications we continue to try to help prevent, but it's one of those things where I think your point about the small percentage, half a percent basically, that developed strangulation in y'all's series. And spending some time there, you have all types of body habitus and ages and physical states. So that gives you a rough idea that the chance of strangulation emergency is really quite low.
Timothy Donahue: Yeah.
Sam Chang: But then understanding the benefit down the road with our hernia surgeons. So look forward to you guys helping us find a way to perhaps preventing these in the future. But very much appreciate all your efforts there in New York and appreciate your leadership and your training. You have many of the fine, fine fellows from Sloan Kettering. Always a warm place in my heart for that place.
Timothy Donahue: Well, thanks very much, Sam. I really appreciate the invitation to talk. And then this was a team effort. As you know, every surgeon was involved and countless fellows over the last decade. So, thank you.