We are once again in the midst of annual hernia meetings, and with those meetings come debates in the field. This month’s column targets just a few of these debated topics. After reading this column, you may feel that some of the most critical debates were not touched on, but this is simply because this area of surgery is fraught with topics on which many are eager to opine. Don’t fret, for this will not be the sum total of focus on hernia in On the Spot in 2013. You can look forward to the July issue to focus on topics such as the need for (or role of) randomized controlled trials in hernia care, sportsman hernia, and biologic mesh versus lightweight, large-pore, synthetic mesh in contaminated situations. In the meantime, enjoy reading the opinions from leaders at the forefront of hernia treatment on topics including the Center of Excellence (CoE) model in hernia care, fibrin glue for inguinal hernia over tacks and sutures, and whether component separation is a standard of care.
Responses here vary. Some speak to the need for standard processes and procedures, as well as the need for a collection of longitudinal data to analyze the effects of these processes. Other responses illustrate the apprehension surrounding generalizing therapy approaches among subpopulations of hernia patients whose treatment needs vary, as well as defining gold standards and standards of care in this area and generally in medicine. Is herniology a field that demands some type of CoE designation, based on the variations in hernia, hernia care and mixed experience from doctor to doctor? Is herniology a field that demands an individualized approach to treatment? We have yet to see just how the ability to provide that level of care will be affected by changes in our health care landscape such as the Affordable Care Act, insurance company coverage determinations and the growing specializations within general surgery, but these contributors have informed opinions from which we all can learn.
Please feel free to email me at email@example.com with any ideas for debate in hernia and other areas of general surgery, thoughts on this month’s column or general feedback. You can comment online as well at www.generalsurgerynews.com. I always like hearing from you!
Dr. Pomp: Disagree. The CoE designation is overused and no longer carries any significance. It makes more sense to mandate adherence to a quality improvement program using metrics determined by a specialty society and vetted by a recognized organization like the American College of Surgeons (like the NSQIP [National Surgical Quality Improvement Program] in bariatric surgery). The problems, of course, are longer-term follow-up, which is notoriously difficult, and establishing an appropriate and objective risk adjustment mechanism to be able to compare outcomes.
Drs. Amid, Chen: Agree. Any attempt to standardize and advocate quality and monitor outcomes is favorable as long as credentialing and validation is determined by an outside, impartial party with uniform standards.
Dr. Park: It is a model, but by no means is it the only or even best model to examine high-quality care and outcomes. I suppose it could be argued that many such programs exist in this country without such a designation, where skilled and dedicated hernia surgeons and caregivers in highly protocolized environments track all they do.
Dr. Ramshaw: Disagree. The CoE model would work well for a more static and less complex application. Although the concepts of standardization of protocols and centralized data management can help minimize very poor outliers, that same model inhibits ongoing adaptation and improvement. We will need to apply principles of clinical quality improvement, where dynamic care processes are defined and managed locally, and value-based outcomes measures are used in real time to improve those dynamic care processes. Also, engaging the patient and family in the process definition and quality improvement is essential to maximize improvement.
Dr. Kaufman: Agree. This has been used most notably with bariatrics and breast cancer, as well as other health care areas, and is an excellent strategy to allow standardization of technique(s) and protocols for different types of hernias and the best manner to approach these types of repairs.
Dr. Bowers: Disagree. The true drivers of quality in hernia repair (chronic pain and hernia recurrence) cannot be accurately measured in the current U.S. system. To make a claim of “excellence” based on perioperative outcomes is ridiculous.
Dr. Sarr: Ideally yes, but then again it depends on whether the CoE criteria are based on documented outcomes or the facility. This has been a big problem for many programs, where the CoE criteria are not outcomes but rather number of cases and a facility having all the bells and whistles.
Dr. Rosen: Several years ago, I would have answered this question with a resounding “yes!” However, as I have learned over the past few years, CoEs simply have not done what we wished they would. I think hernia surgeons cannot overlook the failure in the bariatrics model. To my knowledge, there are little to no data that actually support that CoEs have done anything to improve quality of care. Although they have compiled ample data, the actual feedback methods and quality improvement mechanisms were never clearly thought out. I think that CoEs will be divisive in hernia surgery and will polarize surgeons and prevent improvement in quality. However, there is an answer, and it is forming quality collaboratives. This model allows surgeons to work together to compile meaningful data, analyze it based on appropriate risk stratification, provide feedback loops to allow surgeons to see differences in outcomes, and most importantly provide a measurement in improvements in quality of care. The American Hernia Society's Quality Collaborative is now being released [see page 14 for story], and I would encourage all surgeons who want to improve the quality of care they give hernia patients to join.
Dr. Powell: Agree. Hernias continue to be bread-and-butter cases for the practicing general surgeon in the community. The hernias that tend to find their way to academic centers tend to be the more complicated, recurrent types. Any model that allows for clinical outcomes research such as a CoE does potentially allow for better care of the complicated hernia patient.
Dr. Voeller: Disagree. Many of the CoEs in hospitals are all about marketing and true quality is not the main focus. The way to ensure high quality is better training and analysis of results of surgeons and applying continuous quality improvement analysis to the surgeons and their techniques. SAGES [the Society of American Gastrointestinal and Endoscopic Surgeons] is looking at better training through the Hernia Task Force and the American Hernia Society is looking at quality improvement through the Hernia Outcomes Group.
Dr. Pryor: Disagree. CoE programs have gained in popularity over the past several years, and are now necessary for insurance coverage in many specialties. However, for a broad field central to general surgery such as hernia, such programs are not practical. Additionally, tracking true outcomes requires extensive follow-up that is less common in many hernia practices.
Dr. Richards: Absolutely not, because the hernia repair should be in the domain of every general surgeon.
Dr. LeBlanc: Disagree. I do not believe that the CoE model will assure this because the usual model requires a certain minimum number of cases to be included. Sometimes all the required items in such models really do not achieve a meaningful difference in outcomes. I would venture to guess that very few of the experts on this panel are participants of a CoE program. Additionally, I am unaware of validated standards for any CoE hernia program that is certified by either the American Hernia Society or European Hernia Society.
Dr. Hutcher: Agree. I understand the controversy and fears associated with this concept; however, using bariatric surgery as a model, several benefits are evident. Standardization of processes and procedures coupled with robust collection and review of data is worthwhile. Even considering the increased rate of minimally invasive surgery and introduction of the [gastric] band, the mortality of bariatric surgery has continued to drop along with the [hospital] length of stay—to the point that the insurance industry tried to declare all bariatric surgery be done on an outpatient basis. The fact that surgeons had their own data on more than 400,000 patients (CoE database), this inappropriate assault was reversed. An independent CoE with input from hernia leaders with credible data will allow this specialty to not only survive health care reform, but to thrive. We all will be accountable for outcomes, cost, transparency and patient satisfaction.
Dr. Park: Not so much!
Drs. Amid, Chen: Selectively. Component separation in patients who have large defects and an adynamic abdominal wall is a crucial adjunct to successful repair and restoration of function.
Dr. Sarr: Disagree. Too many people are having a separation of components (in my opinion because the charges for the procedure are so exorbitant—a crime for a procedure that takes 20 minutes, but the surgeon can charge an inordinate amount of money)—not all hernias need it!
Dr. Pomp: It certainly seems so given the recent epidemic of courses, seminars and publications. Nonetheless, it is my experience that component separation without medial and/or lateral reinforcement with nonabsorbable mesh that the recurrence rate is unacceptably high.
Dr. Rosen: I think the term component separation has really led to a lot of confusion about abdominal wall reconstruction. In principle, there is a multitude of ways to perform this procedure. Although each has its own advantages and disadvantages, in my opinion the key point is to understand the objective of the procedure and not necessarily how one performs it. In practice, the concept of a component separation is to reapproximate the midline. This should be done in the least invasive way possible, while providing adequate advancement, as well as preservation of the neurovascular anatomy of the anterior abdominal wall. The lack of good comparative data, with relatively short-term follow-up, and a broad spectrum of patients undergoing this procedure prevents the classification of standard of care at this point.
Dr. Voeller: Standard of care for what? I am always hesitant to use a legal term when talking about surgery. Lawyers love it when we doctors say something is the standard of care. Component separation is an important tool for herniologists to understand and be able to apply as they see fit. As I see it, its role is still being defined.
Dr. Powell: It is the standard of care for improved cosmesis and returning a functional abdominal wall. For patients with larger defects, it is the best method when coupled with mesh prosthesis. For patients with small Swiss cheese—type defects, laparoscopic ventral hernia repair still plays a role.
Dr. Pryor: Disagree. Although component separation is a great tool to facilitate native tissue abdominal wall reconstruction, it is not the ideal technique for repair of all hernias in all patients. Therefore, I consider it an acceptable option, but not standard of care.
Dr. Richards: It’s not standard of care, but it is a really valuable technique in the right circumstances.
Dr. LeBlanc: It is the standard of care in “the appropriate setting.” The issue here is the term appropriate setting, as well as the fact that there are many variations of the component separation procedure itself. There are many other unanswered questions such as should mesh be used? If so, which mesh? Where should it be placed? Although there is definitely a need for this procedure, and I do believe that there are still many issues related to its use, the biggest problem with it is the fact that there are many surgeons performing the procedure with little understanding of its anatomic changes and the resulting physiologic alternations, including the management of its frequent complications.
Dr. Ramshaw: Disagree. For any complex medical condition, there can never be a “standard of care.” Any “best practice” will be of value and help many patients. However, that same “best practice” also will be of less value than other options for some patients and may actually harm some patients. We are beginning to see this throughout health care, from screening tests, such as breast mammography, to drug therapies and invasive procedures. We need to gain a better understanding of how to apply the best therapy for each patient subpopulation, not as a “best practice” or “standard of care” for all patients.
Dr. Kaufman: This may not be considered the standard of care at this time secondary to the fact that many surgeons may not yet be sufficiently experienced with this technique. It has evolved to either anterior or posterior TAR [transversus abdominis release] techniques. These are applied to different types of patients and in different settings based on how much fascial advancement is required. This should be used as an adjunct procedure in the setting where closure of the midline is not possible, so that you can assure tension-free closure of the linea alba where it would not otherwise be able to be achieved.
Dr. Hutcher: On the fence. This is an important tool in difficult situations, especially in contaminated wounds, recurrences and trauma. I don’t believe there are enough data from multiple sources to label it as standard of care, which is a term that only further emboldens plaintiff attorneys.
Dr. Voeller: My favorite topic. I don’t think we should say preferred because sutures and tacks, when used properly, give very good results. However, since 2003, in more 1,500 inguinal repairs, I have used fibrin glue for my TEP [totally experitoneal procedure] and Lichtenstein repairs and it is my method of choice. I can use the glue for fixation where tacks are not safe laparoscopically. Excellent experimental studies by Kes, Schwab, Katkhouda and others show the many advantages of fibrin glue. There are also many, many clinical studies that support its superiority over tacks.
Dr. Pomp: Fibrin glue is expensive
and confers little advantage over no tacks or sutures in a TEP repair. It may serve some function in TAPP [transabdominal
preperitoneal] repairs to close the
peritoneum, but I have had no episodes of
inguinodynia/nerve entrapment even in thin patients with absorbable tacks.
Dr. Park: There is only a handful of small prospective randomized trials addressing this question, none of them multicentered. So I would not yet agree that it is the preferred fixation modality.
Drs. Amid, Chen: This depends on the method of operation and the type and size of hernia. Although data have been favorable, we still need longer-term evidence, particularly for direct and large hernias.
Dr. Sarr: It’s debatable. Another trial that needs to be done using the
Dr. Powell: I currently use fibrin glue for my TEP repairs and think it works nicely. It doesn’t cost more than a tacker, and allows the mesh to conform nicely to the preperitoneal space. Earlier this year, there was a study that demonstrated a similar recurrence rate with tacks and fibrin glue, but the patients with tacks had more pain at three months postoperatively. Longer-term data are somewhat lacking. There have been a few other studies that lean toward similar results. It is likely that more and more surgeons will use glue for their laparoscopic inguinal hernia repairs going forward.
Dr. Kaufman: This approach should be studied in a randomized controlled trial with head-to-head comparisons to all of the available products on the market. There is a great deal of variability with the properties of the current glues that are available on the market. When the ideal glue is identified, fixation will be readily achieved without tacks or sutures. This transition should have a significant effect on postoperative pain and may completely alleviate periostitis pubis sometimes seen with laparoscopic hernia repairs.
Dr. Ramshaw: Disagree. It is not that simple. Although I think glues do play a role in improving the value for the patient, we will need to apply the principles of clinical quality improvement and determine the real value of products and techniques over the patient’s entire cycle of care to determine where glues have the best value and where other fixation strategies have the best value. For a complex medical problem, there will rarely be one strategy that has the best value in all situations.
Dr. Rosen: I am not sure it is preferred over tacks or sutures, but it definitely should be considered. One of the biggest advantages of fibrin glue is that it allows you to secure the mesh over the vessels and triangle of pain without risk of neurovascular injury. I think for those surgeons who use no fixation, this is a very viable option.
Dr. Pryor: I still prefer tacks, although I now use absorbable ones, and use them sparingly in the groin. I also use suture fixation for ventral hernia mesh.
Dr. Bowers: Lightweight mesh should be fixated.
Dr. Richards: I continue to use tacks for the laparoscopic repair and suture for open repair.
Dr. LeBlanc: There is enough evidence to support this claim. At the very least, fewer sutures should be chosen and absorbable ones at that. I do not believe that permanent tacks should be preferred for an inguinal hernia repair, especially the open method. Permanent products (sutures or tacks) result in an increased incidence of chronic inguinodynia. There are a few products available that require no fixation of any kind (which might be the future of meshes in inguinal hernia repair).
Dr. Hutcher: Disagree—my short answer is neither! I have done laparotomies on many patients who have previously had tacks. I have found these tacks migrated in every nook and cranny of the abdomen, including deep in the wall of the colon, small bowel and iliac artery. My experience with glue in surgery and home repairs has never lived up to advertisements. I keep coming back to the database. Each of these questions could have its own module for detailed study.
Dr. Rosen reported being a speaker for Davol and Lifecell and reciving a research grant from W.L. Gore. Dr. Pryor reported owning stock in Transenterix; having stock options in Barosense and being a speaker for and receiving research support from Novadaq. Dr. Ramshaw reported offering speaking, teaching and/or advisory board services to Atrium, Bard/Davol, Baxter, Covidien Ethicon, LifeCell, Novus Scientific, MTF, STS and WL Gore.
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IRB, institutional review board