This month in Part 2 of the Art of Herniology, I am focusing on topics such as the need for randomized controlled trials in hernia care; treatment of sportsman hernia; and biologic mesh versus lightweight, large-pore synthetic mesh in contaminated situations.
As with Part 1 [February 2013], responses highlight the variability in hernia management and the difficulty for these thought leaders to agree or disagree with any of these statements without qualifying their responses. Although in some areas of hernia management, there is a place for standard processes and procedures as well as for a collection of longitudinal data to analyze the effects of these processes, these surgeons’ responses also illustrate the difficulty of 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 in medicine in general. These contributors have informed opinions from which we all can learn, and the result of their collective thinking is a balanced look at the issues and the complex variables that also must be considered.
One other note: I asked participants to weigh in on the most overrated new technology in surgical care for the Gut Reaction table on page 29, and after reading the responses, you will see there is clearly consensus on one point (hint: the robot). That said, there is discussion to be had on this topic, and in an upcoming issue, On the Spot will tackle the relevant debates in robotics for a balanced look at this new and intriguing technology.
Please feel free to email me (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 and comment online as well. I always like hearing from you!
Ms. Hutchinson is a medical communications consultant based in Philadelphia.
Parviz Amid, MD, FACS, is clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles.
Steven Bowers, MD, is assistant professor of surgery, Mayo Clinic, Jacksonville, Florida.
David Chen, MD, MD, FACS, is assistant clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles.
Neil Hutcher, MD, is chairman, Board of Directors, and chief medical officer and vice president of clinical quality and compliance, Surgical Review Corporation, Raleigh, North Carolina.
Jarrod P. Kaufman, MD, FACS, is general and advanced laparoscopic surgeon, Advanced Surgical Associates of Central Jersey, Freehold, New Jersey.
Karl A. LeBlanc, MD, MBA, FACS, is associate medical director at Our Lady of the Lake Physician Group, director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, Baton Rouge, Louisiana.
Adrian Park, MD, is chair, Department of Surgery, AAMC Surgical Specialists, Annapolis, Maryland.
Alfons Pomp, MD, FACS, FRCSC, is chief of laparoscopy and bariatric surgery, vice chairman, Department of Surgery, and the Leon C. Hirsch Professor of Surgery and attending surgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York City.
Benjamin S. Powell, MD, FACS, is with Mid-South Center for Minimally Invasive Surgery, Germantown, Tenn., and is assistant professor of surgery, University of Tennessee Health Science Center, Memphis.
Aurora D. Pryor, MD, is professor of surgery and vice chair for clinical affairs, chief, general surgery director, Bariatric and Metabolic Weight Loss Center, Department of Surgery, Stony Brook University School of Medicine, Stony Brook, New York.
Bruce Ramshaw, MD, is co-founder, chairman and chief medical officer at Transformative Care Institute, and director, Advanced Hernia Solutions, Daytona Beach, Florida.
William Richards, MD, FACS, is professor and chair, Department of Surgery, University of South Alabama, Mobile.
Michael J. Rosen, MD, FACS, is associate professor of surgery and chief of the Division of GI and General Surgery at University Hospitals of Cleveland, Case Medical Center, and the director of the Case Comprehensive Hernia Center, Cleveland, Ohio.
Michael G. Sarr, MD, FACS, is the J.C. Masson Professor of Surgery and vice chair of research in the Department of Surgery at Mayo Clinic, Rochester, Minnesota.
Guy R. Voeller, MD, is professor of surgery, University of Tennessee Health Science Center, Memphis.
The gold standard for determining the best procedure or hernia mesh for hernia repair is the prospective, randomized controlled clinical trial.
Dr. Bowers: It takes several years to complete and publish the results from such trials, but the technologies involved in hernia repair change substantially every year. The U.S. surgeon generally performs the procedure that is best for him or her to perform. Regarding hernia repair, surgeons should only do what they do well.
Dr. Voeller: I have said for years there is no one best procedure or mesh for hernia repairs. There are many excellent repairs and meshes that give good results. The controlled trial often leaves many questions unanswered and poses new ones. Trials are important but very difficult to do well. I think we must pay more attention to long-term longitudinal or observational studies. Now that quality is the key issue in surgery, we can learn a lot from a surgeon who does hundreds of the same operation a year and has superb results. We don’t need a controlled trial to tell us he or she has a “gold standard.”
Dr. Sarr: Unfortunately, I think it probably is in 2013 primarily because the population that everyone studies is so heterogeneous, especially for the biologics. The study would have to have very strict entry criteria.
Dr. Pomp: International currency is no longer based on a “gold standard” and the term is outdated. Laparoscopic and “open” expertise varies and, as the VA trial showed [N Engl J Med 2004;350:1819-1927], comparing types of repair and establishing superiority in a heterogeneous population is difficult. There are several different types of hernia repair that give good outcomes when done by proficient surgeons. Bilateral and recurrent hernia after a previous open approach is likely done better laparoscopically (TEP [totally extraperitoneal] or TAPP [transabdominal preperitoneal]) by an experienced surgeon; otherwise, the literature can (and does) show support for many types of repair.
Dr. Rosen: Agree—I think that today that is the correct answer. However, any good, prospective randomized trial really asks a very specific question and the results are not always applicable to everyday practice. If surgeons are going to use the data from a randomized trial to guide their practices, it is important they look very closely at the inclusion and exclusion criteria to see if their clinical situation is actually addressed in the study. The current problem with using randomized controlled trials to guide our practice is that it is very hard to complete these trials, including obtaining funding and enrolling patients in a timely fashion. I think the only way we will ever get to this level is if every surgeon decides he or she will not use a new product, mesh or technique until there is some higher level of data to support its use. This will force medical device companies (like pharmaceuticals) to provide adequate data to support their claims.
Dr. Pryor: Although I completely agree that prospective, randomized clinical trials are the highest level of scientific rigor available, they are not practical for many facets of the rapidly evolving and variable field of hernia management. Mesh choices are constantly evolving and new techniques are coming to the forefront in ventral hernia repair, for example. Large clinical trials are difficult in these circumstances. However, for specific applications such as uncomplicated inguinal hernia, prospective randomized studies are more reasonable and do help us define ideal management.
Dr. Ramshaw: Disagree. Until now, the prospective, randomized controlled, clinical trial has been considered the gold standard for medical research. This type of scientific tool is a product of reductionist science. It works well for simple and complex mechanical systems. However, it is severely inadequate to explain complex adaptive or biologic systems. To determine what mesh, technique, etc., is best for which patient subpopulation will require the tools that are being developed from complexity science, like clinical quality improvement research (which is actually what we should be doing as a normal part of our care delivery). I recommend watching Malcolm Gladwell’s TED talk about spaghetti sauce to help understand how these concepts were applied to the consumer food industry several decades ago.
Dr. Powell: Theoretically yes, but that is difficult to do. Not all hernias are uniform in nature, and it can be difficult to compare apples to apples. The other issue is continuing long-term follow-up on a lot of these patients.
Dr. Kaufman: Prospective randomized trials are the appropriate way to prove efficacy and/or superiority (or inferiority) of comparable treatments or devices and minimize the bias. They are the best way to test items head to head, but these studies are also costly to administer and require a large number of ancillary staff to assist in completing these types of tasks. However, it becomes increasingly difficult to accrue patients to certain types of trials in the modern health care environment.
Dr. Park: The “ultimate” gold standard to determine best hernia repair or any other intervention is, in fact, the multicenter, randomized prospective trial. These are extremely difficult to design and execute, and it is why so few such hernia studies have been successfully performed, with adequate accrual, etc. So we often are left with lesser levels of evidence—more practically achieved—to inform our hernia management decisions.
Dr. Richards: Agreed, there is no question that these types of clinical trials have been instrumental in demonstrating best methods for approaching the repair of hernias.
Statement: Regarding the treatment of sportsman hernia, rest and medical treatment is the preferred method of care over surgery.
Dr. Pryor: I recommend rest and nonsteroidal [anti-inflammatory drug] therapy for most patients with sports hernia as first-line treatment. For patients presenting with severe pain or with an acute onset of symptoms and a tearing sensation, surgery should be considered earlier.
Dr. Rosen: No-brainer! I think that all surgeons should take a serious pause and put the knife away for a disease that really makes no sense if you think about it!
Dr. Powell: I feel that there is still some controversy in this area. Some studies show that athletes who undergo repair have a higher chance of returning to full activity in three months as opposed to rest and medical treatment. The tricky part is seeing exactly which patients will likely benefit from repair. These patients really should go to a center that has a multidisciplinary approach to athletic pubalgia to tailor a recovery program that is best for the athlete.
Dr. Voeller: On the fence. Depends on pathology and surgeon. Both approaches are important, but nonoperative therapy frequently fails. If you are using the term “sportsman hernia” as created by Malycha in 1992 to mean a weak inguinal floor only with no other pathology, then repairing this weakness gives good results in the majority (not all) of cases. Surgery also is indicated in some of the other causes of groin pain in the athlete.
Dr. Richards: Agreed, surgery should be reserved for true hernias.
Dr. Ramshaw: Agree and disagree. If it worked in a reasonable time period, I think everyone would agree that conservative treatment would be preferred over surgery. However, there can’t be a “preferred method” that will work for all patients. Some patients will not be able to return to their sport or activity without more aggressive treatment, including surgery. It will be best when we can identify the subpopulation of patients who would respond well to conservative therapy and those who would require surgery to return to a full quality of life.
Dr. Sarr: Disagree. Virtually all studies have shown that operating is better and gets the patient back to normal function much faster. There is, however, a problem with the diagnosis of “sports hernia,” and not all surgeons are talking about the same etiology/pathogenesis! We need a classification system for the spectrum of diseases of sports hernia.
Dr. Bowers: Acute tears should be repaired if they do not respond to a course of rest and medical therapy, but chronic tears are unlikely to respond to conservative measures.
Dr. Kaufman: In general, I agree with this statement, and accuracy of diagnosis for these types of patients is critical as this type of hernia tends to be “overdiagnosed.” The diagnosis can be made with physical examination and sometimes is aided by MRI [magnetic resonance imaging]. If after six to eight weeks of rest and physical therapy the patient still has severe pain to palpation and/or activity, then surgical intervention should be considered and can be done with either an open or laparoscopic approach.
Dr. Park: It is certainly the preferred initial course of treatment. Although our surgical approach of choice is laparoscopic, the difficulty in dealing with these patients is obviously not the technique or conduct of the repair, but rather appropriate patient work-up, selection for and timing of surgery.
Statement: Lightweight, large-pore synthetic mesh performs better than biologic mesh in contaminated situations.
Dr. Pomp: I will leave the discussion of this hernia to the experts, but the correction of attenuated fascia over exercise (or medication)-induced hypertrophic muscle may well require surgical repair.
Dr. Pomp: Biologic mesh in a severely contaminated wound inevitably becomes expensive biologic slush and this approach should mostly be condemned. Lightweight, large-pore synthetic mesh may tolerate infection surprisingly well. The option of synthetic (cheaper) resorbable mesh should remain part of the surgeon’s armamentarium.
Dr. Voeller: We should know soon with trials now ongoing. My own bias for several years has been a strong yes. I was never a biologic mesh user. I did not believe the hype. After Jåne’s work in 2004 on stoma hernia prevention [Arch Surg 2004;139:1356-1358], I have used large-pore synthetics to prevent parastomal hernia in my colon surgery and have never had a mesh infection. Additionally, I have many cases of onlay mesh repair of large ventral hernias with lightweight polypropylene mesh in contaminated situations. If a wound infection occurs, I open the wound and place a wound VAC [vacuum-assisted closure], and the mesh is covered quickly with granulation tissue and never lost.
Dr. Richards: Although the lightweight, large-pore mesh has shown to be superior to older mesh types, the use of biologic mesh is still preferred in contaminated fields.
Dr. Sarr: I know of no good data to support this one way or the other. I trust many surgeons are uncomfortable putting
an alloplastic prosthetic into an infected field. This topic needs a controlled trial study!
Dr. Powell: If one looks at the literature, the answer would likely be yes. Today’s lightweight, large-pore mesh seems to do fairly well in certain situations. However, I would still hesitate to use a permanent synthetic in a grossly contaminated field such as feculent peritonitis. Biologic mesh does not seem to be the answer for long-term hernia repair.
Dr. Pryor: Most hernia surgeons find contaminated fields a challenge. However, I think we are seeing increasing evidence that lightweight, large-pore synthetic mesh may be a good solution in these situations. Although biologic mesh has been used, long-term results are disappointing.
Dr. Rosen: Too early to tell at this point. There is a very compelling retrospective case series that suggests in certain circumstances, these lightweight synthetic materials can withstand contaminated situations. Whether that will result in a long-term advantage or a decrease in hernia recurrence rates is unknown at this time. Our group is actually performing an FDA-monitored, prospective, randomized trial evaluating lightweight polypropylene mesh versus a biologic mesh for the repair of clean-contaminated and contaminated ventral hernias. Until this trial is completed, I think it’s too early to make any conclusive statements.
Dr. Ramshaw: Disagree. I think we have learned the one-size-fits-all thinking is not a reality to produce the best value in health care. Neither biologic mesh nor lightweight polypropylene is “better” for contaminated situations. We also need to look at overall value for the long-term outcomes, not just short-term quality measures. There are now coated lightweight polypropylene options that may allow better durability, long-term resorbable meshes that are less costly than biologics and might work well in these situations, and the potential for next-generation biologics, such as nanoparticle crosslinking materials, which might add value to the use of a biologic mesh.
Dr. Bowers: Intraperitoneal mesh of any type is unlikely to perform well in contaminated situations, and retrorectus biologic and lightweight synthetic meshes are both likely to perform well in contaminated cases. My experience with lightweight synthetics are that they can almost always be salvaged in case of infection, provided the mesh is flat, extraperitoneal, has viable muscle coverage, and negative pressure therapy would be appropriate.
Dr. Kaufman: A well-designed, randomized controlled trial will be the optimal way to answer this very question. In some cases, this is accurate and can be achieved without major consequences with concurrent use of antibiotics and appropriate drainage and lavage of the contaminated surgical field. Depending on the degree of contamination and the clinical scenario (i.e., extent of tissue loss), I still would prefer a biologic mesh in most of these instances, unless there is minimal contamination.
Dr. Park: Not yet, although performance of biologic in this situation is still variable.