A Mix of Consensus And Controversy on Recommendations
Rotterdam, Netherlands—Let the voting begin. The bustling auditorium at the 2016 International Congress of the European Hernia Society (EHS) quieted as more than 200 surgeons logged onto the EHS website to cast their votes on 50 global statements and recommendations for managing groin hernias.
Although surgical societies including the EHS have created guidelines for inguinal hernia surgery in the past, this marks the first attempt at world guidelines.
“The main goal of these guidelines is to improve patient outcomes and standardize care worldwide,” Maarten Simons, MD, general surgeon in the Department of Surgery at Onze Lieve Vrouwe Gasthuis Hospital, in Amsterdam, told the audience at the “Consensus Meeting” session.
Existing guidelines, which often reflect the values and practices of a particular region, have not yet achieved this goal. The current body of literature on inguinal hernia repair still shows wide variations in surgical practice and patient outcomes, with estimates for recurrence and chronic pain as high as 15%, depending on the analysis, surgeon and institution.
“We ideally want recurrences below 5% and chronic pain below 1%,” Dr. Simons said. “But that’s difficult to achieve with so many different meshes and prosthetic devices, and the variability in the way they are used.”
In 2014, a group of 50 experts from seven hernia societies worldwide joined forces and established the HerniaSurge Group to create a set of recommendations for all hernia surgeons based on the best available evidence.
“This was a herculean effort by many people,” said Robert J. Fitzgibbons, MD, the Harry E. Stuckenhoff Professor and Chairman of Surgery at Creighton University School of Medicine, in Omaha, Neb., who helped draft the guidelines.
Over six months, these surgeons divided themselves into groups dedicated to subtopics ranging from technique and mesh preferences, to anesthesia and prophylactic antibiotic practices, to education and training requirements. After combing through more than 3,500 articles, the international cohort ultimately whittled down the evidence to 50 essential statements and recommendations, which were subsequently graded by level of evidence (very low, low, moderate or high) and recommendation strength (weak or strong).
At the 2016 EHS congress, members of the HerniaSurge Group unveiled a draft of the guidelines for the first time. The purpose of the session was to engage a larger community of surgeons in the process and to vote on each guideline.
“Today is all about the consensus,” Dr. Simons said.
Marc Miserez, MD, PhD, a general surgeon at University Hospital Gasthuisberg in Leuven, Belgium, approached the microphone to begin reading the guidelines. Dr. Miserez indicated that a consensus would be reached if 70% or more voters agreed with the recommendation as well as its strength and level of evidence.
The first guideline—“Clinical examination alone is recommended for confirming the diagnosis of an evident groin hernia”—passed that threshold with 80% of voters agreeing on the recommendation, the strength as “strong” and the level of evidence as “low.”
A handful of other recommendations achieved a strong consensus:
92% agreed, recommendation strong, evidence low: “In patients with primary bilateral hernias a laparo-endoscopic approach is recommended provided expertise is available.”
91% agreed, recommendation strong, evidence high: “Although most patients will develop symptoms and need surgery, watchful waiting for minimal or asymptomatic inguinal hernias is safe since the risk of hernia complications is low and can be recommended.”
83% agreed, recommendation strong, evidence moderate: “A mesh-based repair technique is recommended for patients with symptomatic inguinal hernias.”
83% agreed, recommendation strong, evidence low: “Nerve anatomy awareness and recognition during surgery is recommended to reduce the incidence of chronic post-herniorrhaphy pain.”
81% agreed, recommendation strong, evidence moderate: “In laparo-endoscopic inguinal hernia repair, TAPP [transabdominal preperitoneal] and TEP [total extraperitoneal] have comparable outcomes; hence it is recommended that the choice of the technique should be based on the surgeon’s skills, education and experience.”
79% agreed, recommendation strong, evidence low: “Hernia surgeons should be aware of the clinical characteristics of the meshes they use.”
74% agreed, strong, very low: “It is recommended that surgeons tailor treatments based on expertise, local/national resources, and patient- and hernia-related factors.”
But several recommendations proved more controversial. About 22% of the audience disagreed that a laparoscopic technique should be recommended in male patients with a primary unilateral inguinal hernia; 26% of voters did not concur that day-case laparoscopic inguinal hernia repair with minimal use of disposables is cost-effective; and more than 36% disagreed that general or local anesthesia is preferred over regional in patients 65 years of age and older.
After the voting ended, the panel circled back to address these more divisive recommendations. One surgeon in the audience, for instance, noted that day-case surgery may not be a financially attractive option in certain hospitals due to local insurance practices. Another surgeon explained that, in Sweden, universities teach the Lichtenstein approach, and, thus, the recommendation to use a laparoscopic technique may not be feasible in that environment.
Even the watchful waiting recommendation, with its 91% consensus and high level of evidence, may not apply universally. Neil Smart, MD, a consultant colorectal surgeon at the Royal Devon and Exeter Foundation NHS Trust, in Exeter, England, noted that in the United Kingdom, policymakers have directed general practitioners to practice watchful waiting in an effort to cut costs. But this strategy has backfired. Dr. Smart has seen patients, who were initially rejected for a surgical consult, receive approval only after the situation had become dire and required emergency surgery.
“The cost of one late inguinal hernia surgery, including hospital stay and complications, could have paid for many repairs if we’d operated sooner,” said Dr. Smart, who also is honorary senior lecturer at the University of Exeter Medical School. “Just because there are guidelines, doesn’t mean they are right or appropriate for everyone.”
Guy Voeller, MD, professor of surgery at the University of Tennessee Health Science Center, in Memphis, questioned the value of world guidelines as well. “I understand why we need to have some common ground in hernia surgery, but I think hernia guidelines are a mistake,” Dr. Voeller said. “There is no algorithmic approach to medicine.”
According to Dr. Simons, between 15% and 30% of surgeons will choose not to follow guidelines because the recommendations do not apply to their daily practice or conflict with their professional autonomy and judgment.
Dr. Fitzgibbons also expects that not all recommendations will be universally accepted. Take the recommendation that mesh repair is superior to tissue repair. “In expert centers, like the Shouldice Hospital [in Thornhill, Ontario], surgeons achieve as good results with tissue repair,” Dr. Fitzgibbons said. “That is why I suggested qualifying this recommendation to ‘in the average general surgeons’ hands.’”
Although the HerniaSurge Group tried to consider the feasibility and usefulness of each recommendation for different countries, it was impossible to account for every political nuance or cultural variation. “As such, it is important to understand that these are just guidelines based on the strongest evidence to date and cannot be considered rules,” Dr. Fitzgibbons said.
Alfredo Carbonell, DO, professor of surgery at the University of South Carolina School of Medicine Greenville, and co-director of the Hernia Center at the Greenville Health System, sees the value in guidelines as a reference for clinical practice but believes the recommendations may not be widely adopted in the United States. “I think guidelines are generally useful for informing clinical practice, particularly for hernia surgery where many questions remain unanswered,” Dr. Carbonell said. Young surgeons especially may be looking for advice on best practices. “But surgeons in the U.S. tend to do what they’re going to do, and may not necessarily wait for guidelines to adopt a new technique.”
Both Drs. Carbonell and Voeller expressed concern that the guidelines may create issues from a legal standpoint. “Guidelines can give lawyers ammunition and be a way for payors and administrators to police how we practice medicine,” Dr. Voeller said. “Attorneys love to whip out guidelines and treat them as law, but rarely understand that guidelines only inform, not dictate, practice.”
Dr. Fitzgibbons clarified that the world guidelines are not designed for government agencies, insurance companies or other regulatory bodies. “In the final version, we will put a disclaimer to reiterate that these guidelines are for surgeons, not third parties,” he said.
Still, even when it’s published, this set of guidelines will not represent the last word on inguinal hernia repair. “It is important to recognize that these guidelines will be continually updated as new data emerges,” Dr. Fitzgibbons said.
Given that surgical practices, health policies and regional resources vary significantly from location to location, the question remains: Will surgical practice actually improve with world guidelines?
“Some surgeons say yes; some say no,” Dr. Simons said. “I can’t say for certain because we don’t have evidence to confirm either way.”
In the future, the HerniaSurge Group will continue to seek consensus on the 50 key statements and recommendations from surgeons in other countries and incorporate feedback from surgeons in different specialties. The group will aim to publish the final version in 2017.