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Hello, Behind the Knife listeners. We are very excited to be back with you for another Journal Club in Colon and Rectal Surgery on diverticulitis with the Leahy Colorectal Surgery team. As always, we have another very, very special guest who's going to be joining us today, and I'm going to introduce them shortly.

So today we're going to talk about some articles central to the discussion on the management of diverticulitis. And so there are lots of different aspects of diverticulitis management that we thought about tackling, but the articles that we're going to focus on today really lay the groundwork For the ongoing COSMID trial, which stands for the comparison of surgery and medicine on the impact of diverticulitis.

And this trial is currently ongoing, and it's a randomized superiority trial of elective colectomy versus best medical management for patients. With quality of life limiting diverticular disease, and we are actually one of the sites enrolling patients as our many centers around the country. So today we're going to dive into the topic of

surgery for diverticulitis.

Is it better the medical management? So welcome to the team. So Dr. Peter West Marcello and Dr. Tess Hanna Alette. Hey guys, it is great to be back together. It seems like a long time. I, Tess, I haven't spoken to you since about 3:00 AM The last, I think it was the last weekend. Oh boy. Yep. Thanks for the call out.

I hope it, there we go. Well, there we go. Called out. I had a great summer. We spent time with Bianca out in the, portland Coast, which was awesome. But it's also September. And you know what that means? It's interview time. So I love seeing this year's applicants coming in. It's fun to talk about the fellowship and residency.

And so, it's great back to be with fall and football. And yeah, the Patriots won. Tell us what's going on with you. Things are good at UMass. So we have our new fellow Francis Hugh coming from Brigham. And we are also excited for the new fellowship cycle to begin. But yeah, not just new fellows, but

we do have a new baby around.

So congratulations on baby number two, Dr. Ouellette how's number two treating you? She's good. She's good. Her initials ended up being CEA, which I think is appropriate for a colorectal child. That was not on purpose. That after the fact we, Oh gosh. Okay. All right. So let me introduce our special guest who's going to be joining us.

I'm very honored to introduce Dr. Jason Hall. So Dr. Hall did his general surgery training at Mass General Hospital filed by his Colon and Rectal Surgery Fellowship at Leahy. After fellowship, Dr. Hall worked as a staff surgeon at Leahy. In his initial years, he received an MPH from Harvard, and his project was focusing on diverticular disease, and specifically, outcomes of patients with diverticulitis treated at Lahey.

He then became Chief of Colon and Rectal Surgery at Boston Medical Center, and now is the Chair of the Department of Surgery at Tufts Medical Center, and the Benjamin Andrews Institute of Medicine. Professor of surgery, Dr. Hall is a

renowned expert and leader in the management of diverticulitis and the lead author on the ASCRS clinical practice guidelines.

And we are thrilled to have a Leahy alumni join us and share his expertise for this section. Welcome, sir. Glad to be with you guys.

So I'm just going to say a few words though, you know, great having Jason be with us. And I give credit actually to Pat working with Jason when he just was finishing up to say, you know, maybe Jason was talking about getting his MPH at Harvard, but that plus the, but Pat putting forth the monies for the research.

To get the scans reviewed. It really laid a lot of groundwork. Jason, tell us a little bit about that though, because I think it'd be great for some of the residents to know, like what happened and how it worked. Yeah. I mean, I think the, I think I owe all of the credit to this, to Pat's vision and the family at Leahy, right.

All of, you know, that

Leahy colorectal is more like a family, maybe even like a pulse. That we all get initiated into, and none of this is me. I mean, I was at Leahy, Pat thought I could do this. I actually, when Pat raised the idea that we should take this huge database of patients with diverticulitis and CT scans, I said to her, Pat, I don't, I'm not sure I know how to do that work.

Well, I need some extra training. And to her credit, she said, yeah, you probably do. And I'll fund not only you going to the Harvard school of public health, which Peter made happen by covering my call for three straight summers. And then she the other thing Pat Roberts did was she helped Higher

group of folks to look through the scans and annotate each, you know, I don't remember how many studies we had over 700 patients included in the study.

And there were many that were excluded. And so all of those scans, multiple scans had to be annotated and reviewed by folks that were trained and paid to do that work for doing a lot of hard work, though, putting it all together to help us write about our experience and really let you become a nationally for your work.

And that was the beginning. Also Jason is the king of burpees. You would see Jason leading the group down the hallway as we're next to each other. So John, let's dive into what we got. You got it. Alright, so let's, yeah, let's get into, let's get into the weeds. So, this is such a common problem for colorectal and general surgeons and so we're gonna review two important studies.

And so for as common a problem as diverticulitis is our basic understanding. Of the pathophysiology behind it and

why patients develop it is still very much an evolution. And so in the last several decades, we have seen some paradigm shifts in the recommendations for who should have surgery and who should go on medical management.

And so we hope to have a good discussion today on how that is still evolving. So we're gonna start off with the five-year follow-up results of the direct. trial, which looked at the long term outcome of surgery versus conservative management for recurrent and ongoing complaints after an episode of diverticulitis.

And we're then going to discuss the laser randomized clinical trial on the quality of life and recurrence outcomes following laparoscopic elective sigmoid resection versus conservative treatment following diverticulitis. So let's get going. Tess, you want to kick us off? Yeah, thanks John.

So I'm going to be talking today about the 1st paper. As John mentioned, the 5 year follow up results of the direct trial. Many of the guidelines suggest that for recurrent diverticulitis. The management should be

tailored to the individual and how these recurrences impact a patient's quality of life.

So these two trials are key in breaking that down more and better understanding how each management strategy impacts patient's quality of life. The direct trial was a randomized trial which compared elective sigmoid resection with non operative management in patients with recurring diverticulitis, and they define this as greater than two episodes within two years.

or in patients with ongoing symptoms or complaints over three months after an episode of diverticulitis. The study was conducted by the Dutch Diverticular Collaborative, and this was from 2010 to 2024. There were 109 patients randomized to either elective sigmoid resection there were 53, or conservative management non operative 56 of the patients were in this arm.

This was for left sided diverticulitis. that was supported by either CT scan or ultrasound or endoscopy.

Ongoing complaints were patients having left lower quadrant abdominal pain and or changes in their bowel habits accompanied by CT evidence of ongoing inflammation or endoscopic changes such as hyperemia.

This trial was of note terminated early due to difficulty in recruitment. Within three months of randomization, if patients were in the surgical arm, they underwent elective sigmoid colectomy with laparoscopy being the preferred approach. Non operative patients were treated with the current practice of at the time, which was lifestyle measures, monitoring, fiber mesalamine and antibiotics were not routinely used.

And so the six month results of that study showed a significantly higher quality of life in patients who underwent sigmoid resection. The aim of this study, now looking at the five years was to determine whether surgical or non op treatment leads to higher quality of life with, in these patients

with recurring diverticulitis at the five year follow up.

So quality of life was a primary end point. And this was measured primarily by the gastrointestinal quality of life index. And they did this at five years. The, this score was significantly higher in the operative group with 67 percent of patients having a clinically relevant increase in their quality of life score.

Secondary quality of life outcome measures were also higher in the operative group. Of note, 46 percent of patients in the medical management group ultimately required surgery due to ongoing symptoms, and those were successfully treated, not non operatively, did not note significant improvement in the quality of life scores.

The five year follow up data demonstrated results consistent with the initial six month. That elective sigmoidectomy patients had higher and increased quality of life compared to the non op group. So they concluded that

surgeons should counsel patients on the improved quality of life, decreased pain, and lower risk of recurrence with surgical intervention, and the possibility of balancing that with the possibility of post op complications.

You know, the study was initially powered at 214 patients to detect a difference and it was ended early due to recruitment issues. This may, you know, overestimate the benefit of the treatment group. I think the study had a pretty high rate of reported complications as well. But despite the higher complication rates that they found in this study quality of life was still higher in the surgical group.

And the, this follow up study doesn't stratify you know, by Hinchy classification, but the original trial. Most patients were HINCI 1 and some were HINCI 2. So I think overall this study provides a good example of the natural history of diverticulitis, rates of recurrence, and how this impacts quality of life.

And, you know, really helpful in kind of counseling our

patients.

So Dr. Hall, comments. What do you think? Well, look, I mean, this is a seminal paper even though it does have some method, methodologic issues. Before this paper, we were pretty much relegated to retrospective reviews, although some of them were well done. And I think the work done at Leahy was very good.

It was essentially a retrospective review of what happened to patients when they were treated with diverticulitis or surgery. But this is an actual randomized trial that compares the two treatment approaches in that group of patients that we struggle with the most. And despite the methodologic issues, I, the finding is real, right?

There is a very marked difference in the performance status and quality of life experience in patients who have surgery versus

medical management. Now, you know, randomized trial is a summary of the findings across a large group of patients. But, I have to say this does converge with my own personal experience.

That the patients that have multiple recurrent attacks, especially within a short period of time or who have ongoing symptoms, are generally mostly helped by surgery. And sometimes the medical treatment or the prolonged medical treatment is more torture for them.

Peter thoughts. Yeah. So, I mean, I think it's it is nice to see, post vector randomized data. I think it's as we will see with the other studies in ourselves, it's hard to recruit, but I'm glad that they did it. The one thing that I do want to highlight though, is that the anastomotic leakage rate in the surgical group was 15%.

And the results were still beneficial.

So it's amazing that even with what we might not call a great outcome, you still had quality of life benefits. So I think it would be even probably more dramatic if you had a 5 percent or less anastomotic leak rate. And then the other part was the crossover that 46 percent of patients eventually go on to surgery.

That's a lot higher than what you might see elsewhere. And is that, is there a cultural issues here that make you push on to getting surgery? So, I think it's a great study. I think it's, it is helps us lay the groundwork for what we're doing, but there were some quirks. Yeah, I mean, it's interesting that the study was stopped for enrollment, but not the 15 percent leak rate, right?

Like, I don't think, like, I don't think any of us would tolerate, you know, you'd get run out of town pretty quickly with a 15 percent leak rate, right? But but that is one of the seminal findings, despite.

technical issues. The patient still felt better.

Yeah, so let's, I'm going to launch into our second paper which nicely complements this one. So, now we're going to talk about the laser randomized clinical trial. So, the aim of this study was to compare outcomes of elective sigmoid resection. And conservative management for patients with recurrent, complicated, or persistent painful diverticulitis at two year follow up.

So this was a multi center, randomized clinical trial, again comparing elective laparoscopic segment resection to conservative treatment, and this was at five Finnish hospitals. This was from 2014 to 2018. And they reported two year follow up. Like the other study, the primary outcome was the difference in GI quality of life index at six months.

Secondary outcomes were that quality of life index at 12, 24, 48, and 96 months, as well as post operative

complications and recurrences within two years. So patients were included if they had three or more episodes of left colon diverticulitis within a two year time period, with at least one episode verified by CT scan or prolonged pain or disturbance in bowel pattern for three months after a CT proven episode.

Patients were excluded if they had a contraindication to laparoscopy, a stricture, a fistula, malignancy, prior sigmoid resection, and then no colonoscopy within two years. two years. So patients in the conservative group received standardized information on constipation and diverticulosis. They were advised to increase fiber, they were prescribed a fiber supplement, and then patients randomized to surgery underwent surgery within three months of randomization.

Patients in the conservative group were managed for six months, and then at six months they could have surgery if they desired, and then sooner if an indication arose. So, 90 patients were included and randomized, 8 patients were

in the conservative group who actually underwent sigmoid resection within 2 years, so 18 percent crossover.

And then in the first year, the mean quality of life index score was higher in the surgery group. However, within 2 years, the scores were actually similar between the 2 groups. In the conservative group 61 percent had a recurrent episode of diverticulitis compared to only 11 percent in the surgery group.

So some important numbers to keep track of. So both the GI quality of life index and SF26 scores were higher in the surgery group at 12 months, but similar between groups at 24 months. They did perform a per protocol analysis to try and overcome that crossover within the groups. Thanks. And did find that the GI quality of life index score was higher in the surgery group, both at 12 and at 24 months.

And it did also note that at 24 months, patients in the surgery group were more satisfied and reported less pain. I'll just note that on intention to treat analysis, there was no difference in

quality of life at two years. You know, I'll just comment that like the other trial, they did intend to enroll 133 patients, but the trial was prematurely stopped due to significant difference in the primary outcome and the interim analysis.

So, I'll just make some comments here. You know, in this study, the rate of crossover was 18 percent compared to the other study of 46%. Which could limit the ability to detect differences between the 2 groups. Trial results were definitely similar in some regard to direct trial at 1 year.

You know, this group was heterogeneous, complicated, persistent, painful, and recurrent diverticulitis were all included, which does make it more challenging to apply more broadly. And they overall conclude that elective sigmoid resection improved quality of life and decreased recurrence of diverticulitis and provides useful information for counseling patients.

So, Dr. Hall, curious what your thoughts are about this paper and then how this one combined with the other one, you know, really informs your practice. Yeah, I mean, when I read this, it's a similar finding. And again, we have some of the same bugaboos

with these kind of randomized trials in terms of enrolling the appropriate number of patients.

But again, I think this tells us a big picture. Surgery is effective. I don't know if you have the table for included, which shows sort of some of the other complications we worry about in this group of patients, but I think. Some of the longer term issues like fistulas and those kind of things are actually higher in the observation group, but not statistically significant.

So again you know, I think it just supports applying surgery as a. As a primary modality. Yeah. And I got to say, when I look at this 1, the leak rate was 5%. You know, much more realistic number where you expect the crossover was also a lot less. Then in a different country, so culturally, things are different.

I think it is hard, though, to. ask somebody who's having chronic pain from diverticulitis to say, don't

have surgery. So that affects your quality of life. I think , in America, if you had persistent disease, you know, we know that the, I think for that group who have chronic pain versus the intermittent episodic pain the other part of this is, you know, no antibiotic therapy generally used for some cases or not.

So there are some differences. Maybe we'll see that when it comes to the U. S. trial. But, again, together, it still says that surgery provides equal, if not better, quality of life. So yeah, I think, and I think that's a good, you know, segue into the COSMET trial. You know, so, of note, right, both these trials were done in Europe.

And so, this is a trial that's ongoing right now. The PI is Dr. David Flum, and then, Dr. Tom Reed is also leading the charge. You know, so the goal of this trial is to answer the question for patients with quality of life limiting divertricular disease is elective colectomy more effective than best medical management.

And so the hypothesis that they're testing is that patient report outcomes among patients in the surgery arm will be superior to those in the best medical management arm. I'll just mention, you know, I'm not going to go through all of the inclusion exclusion criteria.

There's a lot of very similar. inclusion criteria to the other studies. You know, essentially, and I'll just say this because I've, you know, like I said, we have been enrolling patients in this. So it's essentially at least one episode of diverticulitis. It can't be quote unquote complicated with a fistula or malignancy.

You need to have had a colonoscopy within five years. And then again, the primary outcome is patient reported quality of life as measured by the quality of life index. I'll just mention that the trial started enrolling in 2019 and then the pandemic hit, you know, I wasn't trying to enroll patients then.

But from what I hear, it was challenging that the trial sounded a little bit like covid. But now, obviously, we're beyond that. And so enrollment is up and running. So we've enrolled over 100 excuse me, enrolled over 200 patients.

Across the country and he's enrolled seven. So that's been really fun to participate in that.

So, Dr. Hall, thoughts about Cosmid and its role and sort of your practice and how you see that contributing to the literature. Yeah, I mean, I think it's important to replicate Or to get some facsimile of the direct and the laser trials done in the states, because practice patterns may be very different.

For example, the Europeans led the charge on non antibiotic management of diverticular disease. That never really caught on here in the states. I, my bias, although I, I'm not sure, like, I can really prove this, is that we're actually more aggressive. surgically here in the States than in Europe, but that may be a big generalization, but that's my sense.

So my thinking is that, you know, this is a good study to do in the States. My the only concern I actually have about the COSMET trial,

because I was there at the beginning of some of the discussions of this, is what constitute best medical management? It's not as clearly defined in COSMET as it was in the other randomized trials, and I think that has the potential to dilute the results.

But nevertheless, I think it's probably the best you're going to do in the States. Cause it's hard to tell people exactly what medic best medical management is. It might be like herding cats to really put a tight definition on that. So, so I anxiously. Await accrual of this trial. It is terrible that it got kind of launched just before the pandemic because it would have been a hard trial to enroll in under normal circumstance.

Yeah, but I'm just happy that it is getting done. And 200. No, it's great. I think what I mean, we're only

500, but much greater than what we're seeing from in Europe and. I think we will accrue because I think people are now feeling back more towards quote normal. Yeah, I agree. I think I'm looking forward to the results.

You know, getting more information to help us guide counseling patients. I think even between the two studies we've already talked about. You know, there's a lot of variability in the literature. You know, who's at risk for recurrence both with and without surgery. As a fellow at Leahy you know, often referenced heard a lot about Dr.

Hull's paper from DCR looking at the long term follow up that I think we were talking about earlier. You know, looking at the initial episode of diverticulitis and what are predictors of recurrence when counseling patients? Dr. Hall and the Leahy group looked at the clinical predict and CT predictors of recurrence after your 1st episode of diverticulitis that was managed successfully non operatively.

And so what they found was

overall recurrence at 5 years was 36%. Complicated recurrence was low at 3. 9%. And I think that's an important. you know, number to know. Family history of diverticulitis, length of the colonic segment involved, retroperitoneal abscess were all high risk features of recurrence. So again, for as common as diverticulitis is, we still need a lot more help in guiding conversation with patients.

I don't know, I remember at, As a fellow hearing about a Leahy score, is that still in the works? Work never completed. Sloppy work, Dr. Hall. Yeah, I mean, yeah, you know, one of our partners, Dr. Sridhar Reddy is, has sort of, rejuvenated the, resurrected the project, I should say, and we presented a couple of interesting findings at ASDRS this past year.

We're in the process of submitting for publication. I will just mention that there is supposed to be a

COSMID score. So, they fill out a bunch of information about their quality of life before Surgery before they're enrolled. And so I and so part of the thought is that you can then go to a patient and say, okay, take these survey questions.

It pumps out a score. And then that should potentially indicate to you whether or not surgery would be beneficial. I think that will depend on the final accrual numbers and whether or not they're able to generate that. So, well, I want to pick Jason's brain a little bit because it's something I've been always sort of thinking about is.

Is what about patients who present, you know, early? In their symptoms versus delayed, you know, I try to look back to sort of, can we find literature that would say that it makes intuitive sense that if you present earlier, you're probably less likely to have less complicated disease. And if you have symptoms for 10, 7 to 10 days, you know, that you're going to have more complicated disease with your 1st bout.

And I think it's been my experience that, you know, young men are stupid. They wait a week on a little

dog. I thought it was. So it's the flu, you know, do we, Jason, do we have any data that says, yeah, duration of symptoms make more complicated disease there? There are a couple of papers. Some of them, like, at least 1 of them from the states, La.

That look at. The number of incident cases of diverticulitis in the same patient and the complexity of the operation as judged by operative blood loss and those kind of things. And as you might predict the more attacks that you've had, the harder the operation was to do and the higher chances of complicated disease.

And the patients that had like four or five, six and seven. So there is definitely something to what you're saying. And, I think all of us have been in the situation where we're operating on somebody who's had

seven attacks treated with diverticulitis, maybe had got admitted and somehow got through it.

And you're there at like seven 30 at night. wrestling against the colon, which is fused to the left ureter in the retroperitoneum, right? Like, I think everybody on this call can relate to that. So, it's kind of, it's interesting to me because this goes back to the literature in the seventies, right? Where you would bring up a clostomy, leave the septic focus.

And there's a reason that that strategy got abandoned, right? Because the patients never really improved. And so, I think there is something Peter to earlier management. Um, I don't know where that line is. I think it's pretty individual. But But yeah, it's just a great discussion as always.

And we really thank you for joining us, Dr. Hall. Let's get to some of our takeaways. So Tess, why don't you get it started for us? Yeah. So I

think when you're reading the literature, understand the patient population before you just apply it to your patient. Everyone is different. And then make sure when you're discussing surgery to really be considering patient's quality of life.

Awesome. Marcello's must knows. Yeah, well, I think if we're going to do an elective resection for doctor disease, you need high quality outcomes, which means you can't have highly great. You've got to do quality work with excellent perioperative outcomes to really drive. I think the best benefits. And I do think there's some biases that I think complicated cases may be preventable if you present sooner in your course rather than later.

And we do need more multi center studies together. And I hope, Jason, that we across the country will do better at ASCRS, allowing these trials and future studies together to share work and to share data. But look forward to the cosmic results.

I think both of these studies, like the take home message is that when you have a patient that's suffering, surgeons have a certain set of skills that still do work, right? I agree with Peter. If we're going to, if surgery is the solution, it's got to be high quality. You certainly can't have a 15 percent anastomotic leap rate.

One thing I am encouraged about the COSMID study is The enthusiasm in the surgical community for that study was very, very, very high. Even before the pandemic, the investigator room for the study was full of surgeons wanting to participate. So I do think it, it's going to accrue successfully. And hopefully it will give us some additional insights.

Awesome. Yeah. Abelson's approach. I really try to focus on the patient centered approach. You know, I struggle at least in my earlier staging career to tell a patient, you know, unless they have a

cancer, you have to do this surgery. So I really do try to make it, you know, What do you think is the best thing for you?

Obviously, I'm there to provide guidance about risks and benefits of each of the different approaches. I will say, I really, really enjoy being able to be a part of the trial and enrolling patients. And so I think, always look for ways that you can, contribute your experience to, the body of research.

So we can advance how we're taking care of patients. So, all right. So with that, we're going to wrap it up. So again, if you like diving into the weeds with us, consider joining us Sunday evenings for our colorectal surgery, virtual education series. You can check out our show notes for this episode for more details.

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