Enhanced Recovery After Surgery with Dr. Mehul Raval
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University are leading an innovative study to evaluate ways to improve recovery and outcomes in children undergoing elective gastrointestinal surgeries. Such protocols have been found to decrease hospital length of stay and lower costs and complications among adult surgical populations. But evidence for pediatric populations is lacking. Mehul Raval, MD, MS, FAAP, FACS, is a pediatric surgeon and the principal investigator on a $3.5 million National Institutes of Health-funded ENRICH-US study (Enhanced Recovery In Children Undergoing Surgery). The study includes 18 U.S. pediatric hospitals around the country. Dr. Raval is an expert in general pediatric surgery and surgical oncology at Lurie Children's and discusses the study as well as some of its preliminary findings.
“The idea is that we can implement a series of small maneuvers that will help restore them back to their baseline state of health or maybe even into an improved state of health a little faster.”
Mehul Raval, MD, MS, FAAP, FACS
Attending Physician, Pediatric Surgery; Vice Chair of Quality and Safety; Department of Surgery; Member, Lurie Children's Surgical Foundation, Lurie Children’s Hospital
Professor of Surgery in the Division of Pediatric Surgery and Pediatrics, Northwestern University Feinberg School of Medicine
- The enhanced recovery protocol is a comprehensive series of small maneuvers before, during and after surgery aimed at accelerating a patient's return to their baseline health or better after surgery. [00:02:58]
- The protocol includes a wide range of maneuvers including: preoperative focus on nutritional status; preoperative application of pain management strategies; employing minimally invasive surgical techniques; avoiding the use of nasogastric tubes, Foley catheters, and surgical drains; prevention of surgical site infections; using less nauseating anesthetic medications; encouraging early mobility and diet advancement post-surgery; among many others. [00:03:58]
- Previous research examining effectiveness of enhanced recovery in adults has been overwhelmingly positive regarding overall health outcomes. [00:08:41]
- One of the largest pediatric surgical studies of its kind, the $3.5 million NIH-funded ENRICH-US study will examine the effectiveness of this protocol in a stepped wedge cluster randomized trial in a wide array of hospitals across a large number of patients, including over 1200 children and their families. [00:09:47]
- The study includes direct communication with patients and their families about the research and will include patient reported outcomes. [00:14:44]
- The study will focus on those receiving elective gastrointestinal surgery, a type of procedure chosen due to opportunities for improvement in standardizing care elements. [00:16:47]
- So far in the study, benefits of the protocol have been numerous, namely empowering and educating patients and their families about treatment and giving them a sense of control and participation in decision-making, while setting expectations about pain management, encouraging mobility, fostering a better understanding of self-care at home. [00:18:04]
- Explore the ENRICH-US Sudy
Erin Spain, MS [00:00:00] This is Precision: Perspectives on Children's Surgery from the Ann & Robert H. Lurie Children's Hospital of Chicago. I'm your host, Erin Spain. On this podcast, we introduce you to surgeons at one of the country's most renowned children's hospitals to find out how they're transforming pediatric medicine. Lurie Children's and Northwestern University are leading an innovative study to evaluate ways to improve recovery and outcomes in children undergoing elective gastrointestinal surgeries. Such protocols have been found to decrease hospital length of stay in hospital costs and complications among adult surgical populations, But evidence for pediatric populations is lacking. Dr. Mehul Raval is a pediatric surgeon and the principal investigator on this $3.5 million NIH funded study, which involves 18 U.S. pediatric hospitals around the country. He is an expert in general pediatrics surgery and surgical oncology at Lurie Children's and joins me today to discuss the study and some of the exciting preliminary findings. Welcome.
Mehul Raval, MD [00:01:25] Thank you.
Erin Spain, MS [00:01:26] Your philosophy as a pediatric surgeon is to treat patients like family and give them the very best care possible. Tell me more about that philosophy and how it inspires you to lead studies such as this and publish papers in your field.
Mehul Raval, MD [00:01:40] Yeah, it's a great question. I always try to put myself in the shoes of my patients and their families as they're trying to navigate a really complex system, like a health care system, and understand how stressful undergoing surgery can be. And I always want to think about how we can better deliver all the different components of health care in an easy to understand way that makes it less intimidating, less stressful, less onerous for our patients and their families. So we start asking questions like how could we be doing the things that we do a little bit better? And those are the questions that oftentimes come from challenges that I see on the front lines as a patient care provider and inspire me to want to dig a little deeper and to maybe unveil some of the things that we could be doing better. Those things turn into research studies and oftentimes publications, and sometimes if we're asking the right questions, as is the case in this scenario, we end up having to do large scale studies to really push the evidence a little bit further and be able to take better care of our patients.
Erin Spain, MS [00:02:38] So the study that we are discussing today in which you are the principal investigator is called Enhanced Recovery in Children Undergoing Surgery, which is abbreviated as ENRICH-US study. So before diving into this study and what it's all about, explain enhanced recovery after surgery protocol to me. What is this?
Mehul Raval, MD [00:02:58] So the enhanced recovery protocol is based on the premise that when kids need surgery, they're not at their baseline. They may be in a sicker state of health. And with surgery, we end up having some controlled trauma and putting the patients through a little bit of physiologic stress, which actually debilitates them even more. And so the idea is that we can implement a series of small maneuvers that will help restore them back to their baseline state of health or maybe even into an improved state of health a little faster. Now there's going to be a natural decline and then a resilient bounce back. And the idea is that with these elements, we can bounce back quicker to our normal baseline state. It's a series of small things. Now, no one of these things is that earth shattering in and of itself. But realistically, if we can do all these little bundled things together, it's the actual implementation of that bundle that's challenging.
Erin Spain, MS [00:03:52] Can you just go through that laundry list of enhancements and just kind of spell them out for us?
Mehul Raval, MD [00:03:58] Enhanced recovery protocols really spanned the entire care continuum. It starts with prior to even coming to the hospital with doing things like patient education about pain management, about diet advancements, and really making sure patients know what to expect with the surgical procedures that are undergoing. It also has to do with preoperative optimization, which for children really takes a look at nutritional status and making sure they have protein stores and that they're coming into the surgeries as prehabilitated as they possibly can be. It then extends into the day of surgery and in the preoperative holding area. In the preoperative holding area, allowing the patients to drink clear liquids up until just an hour before the anesthetic exposure is really important for hydration and keeping their glucose levels normal. Oftentimes, you're told nothing to eat or drink after midnight. And that's something that we've been doing in health care for years and years. Well, the reality is that it wasn't really based on science. That was just best practices as we knew. And so the modern evidence shows that you can actually drink liquids, clear liquids, sugary drinks like Gatorade or apple juice up until an hour before you're scheduled to undergo your procedure. Some of the multimodal pain strategies that will begin in the preoperative holding area, things like giving patients a dose of Tylenol and using some other medications, other pharmacologic medications that help control nerve pain and things along those lines. We also work with our anesthesia colleagues to pre-operatively start using things like scopolamine patches, which can help with nausea and some of the queasiness that happens during anesthetic exposure. We also employ the use of regional blocks, which are kind of like local anesthetics to help keep an area where an incision may be numb rather than depending on just postoperative opioids at the end of the case, to control the pain after the pain has already set in. In the operating room, we do a lot of little things like keeping the rooms nice and warm so that patients don't get hypothermic during surgery. We also use things like minimally invasive surgical techniques to keep the incisions as small as possible. We avoid the use of N.G. tubes, which are nasogastric tubes that go down your nostril and can be quite uncomfortable that are meant to empty the stomach. And so we avoid the use of N.G. tubes or Foley catheters, which are urinary drains. We also try to avoid any surgical drains. And by eliminating many of these drains and tubes and lines, we're able to free the kids up so that they can get up and move easier after surgery. In the operating room, we're using wound protectors and making sure to do all the things to help prevent surgical site infections. We work with our anesthesia team to limit the intraoperative fluids that patients are getting and to use some anesthetic medications that are less nauseating and then some additional medications, maybe once again to prevent postoperative nausea and vomiting. In the recovery area, as soon as the patients emerge from anesthesia and wake up, we let them start having clears, which is really fantastic. And they really, really like that because many of them are hungry by that point in time. And once again, we try to avoid the opioids and use many of the mindfulness strategies and other non-opioid nonpharmacologic techniques to help control pain. They get to the floor in the postoperative phase and we want them up and walking and sitting up in the chair and really advancing their diet as they see fit. We try to limit fluids and once again limit opioids. And ultimately all of these things in concert help the recovery phase happen faster and hopefully we get them home back to their own bed to sleep in and around their family and friends. And on the road to recovery.
Erin Spain, MS [00:07:24] Is the ENRICH-US study the first to study the effectiveness of this protocol in pediatrics?
Mehul Raval, MD [00:07:30] Well, it's the first to study the effectiveness of this protocol in a wide array of hospitals, in a wide array of settings across a large number of patients. There are several single center studies limited to, you know, I would say dozens, if not less than 100 patients that have proven that enhanced recovery protocols look promising. But to really make that concept generalizable to the masses, we need to have larger studies that have a little bit more power and ability to detect the differences that enhance recovery can make. Let me take this a step further and just mention that a lot of the work that we're doing is inspired by work that's been proven in large clinical trials in the adult population. And so it's just a matter of taking the time to understand that kids aren't just little adults and what components of an adult enhanced recovery protocol would fit well for children and can be applied easily, which things might need to be adapted slightly for the pediatric population, and which things are going to be acceptable, acceptable to children's surgical care providers, acceptable to parents and acceptable to our patients, the kids.
Erin Spain, MS [00:08:31] And you mentioned this has been studied in adults. So what have the outcomes been in these adult studies, and is this now part of best practices protocol for adults undergoing surgery?
Mehul Raval, MD [00:08:41] Absolutely. The adult literature is bountiful. A variety of surgical conditions ranging from GI surgical conditions and colorectal surgeries, but really spanning to all types of surgical procedures in the adult world where for the most part, the results show that with the implementation of an enhanced recovery bundle, folks can expect to have a decrease in length of stay. They can have fewer complications and a quicker return to baseline activities. There's even been some studies that have looked at cost effectiveness showing that enhanced recovery bundles can actually be cost savings within the health care system and for patients and families. With that promising adult literature that exists, the question becomes how does that translate when we talk about taking care of kids? And so that's where this study is really going to fill the gap of knowledge.
Erin Spain, MS [00:09:26] And again, this is a $3.5 million NIH funded study. It's a multicenter study. It's going to include over 1200 children and their families at 18 different sites at pediatric children's hospitals across the country. And it's actually one of the largest pediatric surgical studies of its type. Explain that to me. Explain the study, the design, the aims of the study.
Mehul Raval, MD [00:09:47] Well, it's been a really fun adventure, putting together the study, figuring out the best way to roll it out and to try to implement enhanced recovery. As you mentioned, we originally wanted to have over 1200 kids enrolled in the study, and I don't know that we're quite going to get to that number. Optimistically speaking, we may get to 600 or 700 patients, which will still make it one of the largest studies of its type ever done. We've had a lot of challenges in the last few years with COVID restrictions and elective surgical delays and decreased staffing that have affected things like elective GI surgery, which is what this specific study focuses on. So even with those caveats, I would say once again, this has been a really fun study to design and conduct. What we wanted to do was create an experience and a study where all 18 centers that have signed up to be a part of the study would eventually get to implement enhanced recovery. What's really fascinating is that it's really hard to randomize, which is basically saying that you either get or don't get enhanced recovery at the patient level, meaning if a patient comes in today, it's hard to say, well, you're going to get all these different enhanced recovery bundle elements and the next day a different patient comes in and they are assigned or randomized to the no enhanced recovery bundle. It's hard to turn that off and say you can't get these enhanced recovery elements. Similarly, it's challenging to design a study, even at the surgeon level, where at any given hospital, one surgeon performs enhanced recovery and one surgeon doesn't. Enhanced recovery spans to anesthesiologist and nurses and so many other team members. So it's hard to turn it on and off based on the surgeon level. So we chose, therefore, to randomize at the hospital level. And like I mentioned, everybody, all hospitals will eventually get the enhanced recovery intervention because that's what they wanted, right? So how do we go about randomizing? Well, we did this in what's called a stepped wedge cluster randomized trial design. And to break that down and make that a little bit more simple to understand, what it means is that everybody is going to get the intervention. The question is, when do you step into the intervention? We took the 18 hospitals and we randomly assigned them to one of three groups. So there were six hospitals in each of the groups and we called these clusters. So the first cluster of hospitals spent about a year just collecting baseline data, collecting data that might include some enhanced recovery elements, but maybe not all. And then they went through an intense year of education by our study team from Lurie Children's and Northwestern. And during that year, we taught them all the tips and tricks that we could think of to try to implement enhanced recovery. And then they had about two years of sustainability where we monitored how they were doing with the implementation of the enhanced recovery protocol. The next cluster of six hospitals, they did a year and a half of baseline data collection, a year of implementation coaching, and then a year and a half of sustainability data collection. And then the final cluster did about two years of baseline data collection, a year of implementation and a year of sustainability. And thus, by the end of the process, all 18 hospitals, all three clusters of six hospitals, all received the enhanced recovery protocol. But we had different ideas about what's happening during the baseline across these 18 centers, and we had different ideas about how quickly they had uptake and implementation of the enhanced recovery protocol. And then last, we have differing lengths of sustainability period so we know if we start to lose out on some of the implementation over time. And so it's been a really fun study to design, a fun study to implement. The other kind of strategic aspect of having it stepped or staged in this way is that it allows our study team here at Lurie Children's and at Northwestern to take time to really work with the hospitals in each of the respective clusters. And that way they can really get the attention they need because implementing a bundle like this is not easy. It's quite complicated. And so this way we could really spend time with those hospitals and help coach them through the process.
Erin Spain, MS [00:13:38] So where are you at right now in the study? What is happening?
Mehul Raval, MD [00:13:41] So at this specific point in time, all the hospitals have just completed, the last cluster has just completed its implementation coaching year. And so now all three clusters, all 18 hospitals are in the sustainability period. What we've learned so far is that many of the hospitals are still working on implementing some of the elements of enhanced recovery. As I mentioned, it's quite complicated and oftentimes it takes a little bit longer than we anticipate. And so while we are in the sustainability phase, we are collecting data, we are watching and helping the hospitals that are still tweaking their enhanced recovery protocols, make some modifications. We're continuing to work with them towards the goal of really trying to truly implement enhanced recovery.
Erin Spain, MS [00:14:21] And you're not just working with the hospitals, these 18 different sites around the country. You're also directly communicating with patients and their families about the study. In a video on the study website, you outlined some very specific steps for things like eating, moving and controlling pain before and after surgery. Tell me about that communication with the children and the families and how important that is.
Mehul Raval, MD [00:14:44] Yeah, this is one of those critical aspects of enhanced recovery protocols that we've learned a lot about. First of all, it's all about setting the right expectations and creating a system that really wants to partner with our patients, partner with our families so that they feel like they are major stakeholders in the enhanced recovery protocol. And I think this is important because it sets the stage for what to expect and it takes a very scary, onerous, stressful experience and allows the patients and families to have, like I said, some ownership and stock in what's going to be happening with them over time. It starts with educating families about what the surgical experience looks like, trying to demystify some of the things that are the most intimidating. But it also means partnering with them before surgery even happens to try to optimize them for surgery. Ultimately, what we want to know is how the patients think the process is going. And so part of the study is collecting what we call patient reported outcomes, not just what your pain level was on a scale from 0 to 10, but asking questions about what kinds of activities you were able to get back to, how quickly you were able to get back to school or work and get back to your true baseline. And so these patient reported outcomes are being diligently collected as well.
Erin Spain, MS [00:15:55] Share with me the types of procedures and the conditions that these young patients have.
Mehul Raval, MD [00:16:00] Yeah, so it's any elective gastrointestinal surgery that patients may undergo. Oftentimes in children and in the pediatric population, we're dealing with patients that have inflammatory bowel disease, things like Crohn's disease or ulcerative colitis. Children can also have gastrointestinal surgery for a variety of other reasons. What we limited the study to in terms of the inclusion criteria were any elective GI surgical procedures where the intestines or bowel needed to be resected or hooked up. And so that's the focus of the study. And it's something that happens not exceedingly commonly, but rather, you know, I would say anywhere from 3 to 4 times a month, even at some of the higher volume centers.
Erin Spain, MS [00:16:40] And why was that a choice? Why gastrointestinal surgery versus something that is more common, like tonsil removal or fracture surgery?
Mehul Raval, MD [00:16:47] Yeah, and that's what's fascinating, is that enhanced recovery protocols can actually help with any number of surgeries. As I mentioned earlier, in the adult world, there's been literature and studies done on a variety of procedure types. In the pediatric world, there have been enhanced recovery protocols designed for many of the same things you mentioned, things like tonsillectomy or orthopedic spine surgery. And so there is no real limit to the number of things enhanced recovery protocols could potentially benefit children. But what we did was we chose gastrointestinal surgery for a couple of reasons. Number one, there is a decent amount of opportunity for improvement in terms of protocolizing or standardizing some of the care elements that we have within gastrointestinal surgery. There's also a significant length of stay associated with most gastrointestinal surgery. So when trying to design a study and powering that study to detect a difference for things like length of stay, we needed something that had a reasonably long, in-hospital length of stay. There are a variety of other things that we are measuring related to GI surgery, such as surgical site infections, readmissions and things along those lines, which are also quite high for gastrointestinal surgery specifically. We picked it because it's a really great topic and a really great area for us to make a lot of improvements.
Erin Spain, MS [00:18:00] Tell you about some of these benefits that you've seen so far in the study that you can share.
Mehul Raval, MD [00:18:04] There are so many. And I think that it comes down to really empowering patients to have some control over what would otherwise be a very intimidating process where folks feel like their lives and their health and their well-being is no longer in their hands. And enhanced recovery protocols really educate families and patients about what to expect and allow them to be a part of the decision making process, which is really, I think, a magnificent way of practicing health care in the modern era. The benefits are things like understanding that it's okay to maybe drink some liquids after surgery, not have so many tubes and drains that are tying you down to the hospital bed so that you can get up and walk around and that we're going to encourage you to. It sets expectations about pain and pain control and knowing what things you could ask for that might be relatively easy and straightforward but we don't often think of. For example, using some ice packs or heat packs or whatever feels good topically can make a big difference when you have an incision or some swelling. In the old days, so to say, prior to enhanced recovery, we would immediately turn to things like using opioids and things along those lines. And what this allows us to do is to liberalize the way that we're approaching health care, empower the patients to understand that they do have options and choices. And that, in turn, really is a self-fulfilling prophecy that helps get them home sooner, gets them back to their baseline, and they understand what to do even at home when they're away from the health care system.
Erin Spain, MS [00:19:34] So have you published some of these results and what can you share with us and what can we expect from that?
Mehul Raval, MD [00:19:39] Yeah, So there's been different components and pieces of this study that we've learned a lot about along the journey towards doing the study. And we've broken off some pieces of that and studied some things like when patients report outcomes or their parents serve as proxies and report outcomes on their behalf. Is that reliable? And what we found is actually that for surgical patients and specifically in this study, that is reliable. The parents are very in tune with and aligned with the viewpoints of the patients themselves. And so these kinds of incremental contributions to literature and to science are very meaningful. The overall study, the results are still to be determined. As I mentioned, we are in the sustainability phase. This is the phase where all 18 hospitals are now implementing enhanced recovery to the best of their ability. They're continuing to enroll patients. And I think the next...the final 100 to 200 patients that we're going to enroll are really going to be able to tell us whether the proof is in the pudding or not. And so I'm looking forward to those results. What I can say so far is that based on our preliminary assessment, it looks like there are some patients who are getting many of the enhanced recovery elements. If we really break it down and there are 18 to 20 enhanced recovery protocol elements, there are some patients who are getting 15 or more. And at least our preliminary data show us that the more elements that someone receives, the better their clinical outcomes will be. So how does that translate to how hospitals go about implementing enhanced recovery? Well, that's really going to be a nice contribution of the ENRICH-US study.
Erin Spain, MS [00:21:08] If there's a parent listening right now and their child is about to undergo a surgery, what advice would you give to them to talk to their care team before the surgery? Is there a way that they can share some of this information and ask for some of these enhanced protocols?
Mehul Raval, MD [00:21:22] Absolutely. I think that's one of the things that is going to help us take this enhanced recovery concept and make it become more of a standard of care, which is just something that we do for all patients all the time. And the way that that happens is by disseminating some of the knowledge. So I'm happy to be sharing some of this information with you all today. But I think that having some knowledge and approaching your surgical care providers and your anesthesiologist about some of the things that they may be able to do to enhance the recovery around the time of surgery is really a conversation starter. And there's a tremendous amount of literature that is growing day by day, year by year that supports these concepts and a lot of tools in our armamentarium already and a lot of tools that are still yet to come. So I'm really looking forward to it growing to where it just becomes normal. It's no longer something special, but rather just the way that we deliver care day in and day out.
Erin Spain, MS [00:22:11] Well, thank you so much for coming on the show today and telling us about the study.
Mehul Raval, MD [00:22:16] No, thank you for your time and allowing us to get the message out there to folks. Appreciate it.
Erin Spain, MS [00:22:22] For more information, including how to make a referral or an appointment, visit LurieChildrens.org.