Giampiero Campanelli

European Hernia Society guidelines on the treatment of inguinal hernia in adult patients

The European Hernia Society (EHS) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS. They are evidence-based and, when necessary, a consensus was reached among all members. The Guidelines have been reviewed by a Steering Committee. Before finalisation, feedback from different national hernia societies was obtained. The Appraisal of Guidelines for REsearch and Evaluation (AGREE) instrument was used by the Cochrane Association to validate the Guidelines. The Guidelines can be used to adjust local protocols, for training purposes and quality control. They will be revised in 2012 in order to keep them updated. In between revisions, it is the intention of the Working Group to provide every year, during the EHS annual congress, a short update of new high-level evidence (randomised controlled trials [RCTs] and meta-analyses). Developing guidelines leads to questions that remain to be answered by specific research. Therefore, we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment. In addition, a short summary, specifically for the general practitioner, is given. In order to increase the practical use of the Guidelines by consultants and residents, more details on the most important surgical techniques, local infiltration anaesthesia and a patient information sheet is provided. The most important challenge now will be the implementation of the Guidelines in daily surgical practice. This remains an important task for the EHS. The establishment of an EHS school for teaching inguinal hernia repair surgical techniques, including tips and tricks from experts to overcome the learning curve (especially in endoscopic repair), will be the next step. Working together on this project was a great learning experience, and it was worthwhile and fun. Cultural differences between members were easily overcome by educating each other, respecting different views and always coming back to the principles of evidence-based medicine. The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project.

Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients

Purpose In 2009, the European Hernia Society published the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. The guidelines expired January 1, 2012. To keep them updated, a revision of the guidelines was planned including new level 1 evidence.MethodsThe original Oxford Centre for Evidence-Based Medicine ranking was used. All relevant level 1A and level 1B literature from May 2008 to June 2010 was searched (Medline and Cochrane) by the Working Group members. All chapters were attributed to the two responsible authors in the initial guidelines document. One new chapter on fixation techniques was added. The quality was assessed by the Working Group members during a 2-day meeting and the data were analysed, especially with respect to any change in the level and/or text of any of the conclusions or recommendations of the initial guidelines. In the end, all relevant references published until January 1, 2013 were included. The final text was approved by all Working Group members.ResultsFor the following topics, the conclusions and/or recommendations have been changed: indications for treatment, treatment of inguinal hernia, day surgery, antibiotic prophylaxis, training, postoperative pain control and chronic pain. The addendum contains all current level 1 conclusions, Grade A recommendations and new Grade B recommendations based on new level 1 evidence (with the changes in bold).ConclusionsDespite the fact that the Working Group responsible for it tried to represent most kinds of surgeons treating inguinal hernias, such general guidelines inevitably must be fitted to the daily practice of every individual surgeon treating his/her patients. There is no doubt that the future of guideline implementation will strongly depend on the development of easy to use decision support algorithms tailored to the individual patient and on evaluating the effect of guideline implementation on surgical outcome. At the 35th International Congress of the EHS in Gdansk, Poland (May 12–15, 2013), it was decided that the EHS, IEHS and EAES will collaborate from now on with the final goal to publish new joint guidelines, most likely in 2015.

EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair

BackgroundAlthough the repair of ventral abdominal wall hernias is one of the most commonly performed operations, many aspects of their treatment are still under debate or poorly studied. In addition, there is a lack of good definitions and classifications that make the evaluation of studies and meta-analyses in this field of surgery difficult.Materials and methodsUnder the auspices of the board of the European Hernia Society and following the previously published classifications on inguinal and on ventral hernias, a working group was formed to create an online platform for registration and outcome measurement of operations for ventral abdominal wall hernias. Development of such a registry involved reaching agreement about clear definitions and classifications on patient variables, surgical procedures and mesh materials used, as well as outcome parameters. The EuraHS working group (European registry for abdominal wall hernias) comprised of a multinational European expert panel with specific interest in abdominal wall hernias. Over five working group meetings, consensus was reached on definitions for the data to be recorded in the registry.ResultsA set of well-described definitions was made. The previously reported EHS classifications of hernias will be used. Risk factors for recurrences and co-morbidities of patients were listed. A new severity of comorbidity score was defined. Post-operative complications were classified according to existing classifications as described for other fields of surgery. A new 3-dimensional numerical quality-of-life score, EuraHS-QoL score, was defined. An online platform is created based on the definitions and classifications, which can be used by individual surgeons, surgical teams or for multicentre studies. A EuraHS website is constructed with easy access to all the definitions, classifications and results from the database.ConclusionAn online platform for registration and outcome measurement of abdominal wall hernia repairs with clear definitions and classifications is offered to the surgical community. It is hoped that this registry could lead to better evidence-based guidelines for treatment of abdominal wall hernias based on hernia variables, patient variables, available hernia repair materials and techniques.

EAES Consensus Development Conference on endoscopic repair of groin hernias

Groin hernia repair is one of the most common surgeries,performed globally in more than 20 million people per year[1, 2]. Historically, the first surgeries for groin hernias wereperformed by the end of the 16th century [3, 4]. Repairsthat involved reduction and resection of the hernial sac andenforcement of the posterior wall of the inguinal canal byapproximating its muscular and fascial components wereperformed by the end of the 19th century. Utilization ofprosthetic material was introduced in the 1960s, initiallyonly in elderly patients with recurrent inguinal hernias.Favorable long-term results of these mesh repairs allowedadoption of mesh repair in a larger group of patients. At thepresent time, the majority of surgeons prefer mesh repair ofinguinal hernias.In the early 1980s, minimally invasive techniques forgroin hernia repair were first reported, adding anothermodality to the management of these hernias [4]. Trans-peritoneal laparoscopic and extraperitoneal endoscopictechniques, collectively known as endoscopic surgery, havebeen developed. There is considerable variation of surgical

Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial.

Objective:Test the hypothesis that fibrin sealant mesh fixation can reduce the incidence of postoperative pain/numbness/groin discomfort by up to 50% compared with sutures for repair of inguinal hernias using the Lichtenstein technique. Background:Inguinal hernia repair is the most common procedure in general surgery, thus improvements in surgical techniques, which reduce the burden of undesirable postoperative outcomes, are of clinical importance. Methods:A randomized, controlled, patient- and evaluator-blinded study (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair [TIMELI]; trial NCT00306839) was conducted among patients eligible for Lichtenstein repair of uncomplicated unilateral primary inguinal small–medium sized hernia. Patients were subject to mesh fixation with either fibrin sealant or sutures. Main outcome measures were visual analogue scale (VAS) assessments for “pain,” “numbness,” and “groin discomfort” on a scale of 0 = best and 100 = worst outcome. The primary endpoint was a composite that evaluated the prevalence of chronic disabling complications (VAS score >30 for pain/numbness/groin discomfort) at 12 months after surgery. Results:In total, 319 patients were randomized between January 2006 and April 2007 (159 fibrin sealant, 160 sutures). At 12 months, the prevalence of 1 or more disabling complication was significantly lower in the fibrin sealant group than in the sutures group (8.1% vs 14.8%; P = 0.0344). Less pain was reported in the fibrin sealant group than in the sutures group at 1 and 6 months (P = 0.0132; P = 0.0052), as reflected by a lower proportion of patients using analgesics in the fibrin group over the study duration (65.2% vs 79.7%; P = 0.0009). Only 3 of 316 patients (0.9%) experienced recurrence. The incidences of wound-healing complications and other adverse events were comparable between groups. Conclusions:Fibrin sealant for mesh fixation in Lichtenstein repair of small–medium sized inguinal hernias is well tolerated and reduces the rate of pain/numbness/groin discomfort by 45% relative to sutures without increasing hernia recurrence (NCT00306839).

Recommendations for reporting outcome results in abdominal wall repair

BackgroundThe literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology.Materials and methodsThe EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction.ResultsA list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of “time-to-event analysis” to report data on “freedom-of-recurrence” rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods.ConclusionA set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.

Pubic inguinal pain syndrome: the so-called sports hernia

Sports hernia (SH) is a controversial condition which presents itself as chronic groin pain. It is responsible for signiWcant time away from work and sports competition, with an incidence of between 0.5 and 6.2% [1–3]. Groin injury is common in soccer and ice hockey players, but SH can be encountered in a variety of sports, and even in normally physically active people [1, 3]. For this reason, we think that it is more appropriate to speak of pubic inguinal pain syndrome (PIPS). Over the past decade, the number of sports-related injuries has increased as a function of increased athletic activities, and the demand for an early return to work and competitive sports puts pressure on the doctor for immediate diagnosis and treatment [1–3]. The anatomy involved, diagnostic criteria and treatment modalities are inconsistently described in the medical, surgical and orthopaedic literature. In fact, there is no evidence-based consensus available to guide the decisionmaking, and most of the studies are level IV investigations [1, 3, 4]. A literature search for SH produces a list of various conditions which may or may not include the real disease: “athletic pubalgia,” incipient hernia, osteitis pubis, “Gilmore’s groin,” “hockey groin syndrome” and “Ashby’s inguinal ligament enthesopathy” are several of the terms that have complete or partial overlap with SH and pubalgia; this is another reason to unite the terminology as PIPS [4]. The diYculty in giving a correct deWnition of this obscure cause of chronic groin pain is due to its unclear aetio-pathophysiology. The majority of the published studies and reviews articles include young adult soccer players as the most frequent victims of SH; however, runners, American football players and ice hockey players frequently suVer groin injuries [1, 5]. It does appear that kicking sports and those involving rapid changes of direction while running predispose an athlete to this condition. Chronic groin pain may originate from the muscles, tendons, bones, bursas, fascial structures, nerves and joints, both in the athletes and in the general population [2, 6]. A deWciency of the posterior inguinal wall is the most common operative Wnding in these patients [7, 8]. A weakened posterior inguinal wall develops an imbalance between the adductors and lower abdominal musculature in these athletes. The strong pull of the adductors, particularly against a Wxed lower extremity, in the presence of relatively under-conditioned abdominal muscles creates a shearing force across the hemipelvis, resulting in attenuation or tearing of the transversalis fascia and/or overlying musculature [1–3, 8–10]. Malycha, Lovell et al. reported an incidence of incipient direct hernia of 50% in their series of 189 athletes. The herniography study revealed a symptomatic impalpable hernia in 51% of male and 21% of female patients, and another study reported a hernia in 84% of elite athletes with groin pain [2, 11]. Gilmore has described a more extensive injury and he has coined the term “Gilmore’s groin.” The injury, which has primarily been described in soccer players with chronic groin pain, consists of a torn external oblique aponeurosis, a torn conjoined tendon, with avulsion of the conjoined tendon and inguinal ligament, and the absence of a hernia [2, 3, 11–13]. Some have disputed Gilmore’s description of G. Campanelli (&) Unit of General Surgery, Day and Week Surgery, Department of Surgical Sciences, University of Insubria, Varese, Multimedica Holding S.p.A., Castellanza, Italy e-mail: giampiero.campanelli@uninsubria.it

New “biological” meshes: the need for a register. The EHS Registry for Biological Prostheses

Non-absorbable prosthetic materials in hernia surgery can cause relatively rare complications, which include chronic pain, a feeling of stiffness with reduced compliance of the abdominal wall, prosthetic erosion/fistulisation and an increased risk of persistent deep infection. Recently, to avoid these problems, new “biological” prosthetic materials have been developed and proposed for clinical use. These materials are all essentially composed of an extracellular matrix stripped of its cellular components, and differ substantially only in their source (porcine small intestine submucosa, porcine dermis or cadaveric human dermis). Because of the numerous variables involved, it is very difficult to conduct a randomised controlled trial. Therefore, the European Hernia Society (EHS) has decided to start the EHS Registry for Biological Prostheses (ERBP). This is a prospective registry in Europe on the use of collagen meshes in (potentially) contaminated circumstances or clean surgical fields. The registry intends to collect some preoperative data on the patient and indication, intraoperative data and outcome data.

Global Outreach Using a Systematic, Competency-Based Training Paradigm for Inguinal Hernioplasty

Importance Sustainable, capacity-building educational collaborations are essential to address the global burden of surgical disease. Objective To assess an international, competency-based training paradigm for hernia surgery in underserved countries. Design, Setting, and Participants In this prospective, observational study performed from November 1, 2013, through October 31, 2015, at 16 hospitals in Brazil, Ecuador, Haiti, Paraguay, and the Dominican Republic, surgeons completed initial training programs in hernia repair, underwent interval proficiency assessments, and were appointed regional trainers. Competency-based evaluations of technical proficiency were performed using the Operative Performance Rating Scale (OPRS). Maintenance of proficiency was evaluated by video assessments 6 months after training. Certified trainees received incentives to document independent surgical outcomes after training. Main Outcomes and Measures An OPRS score of 3.0 (scale of 1 [poor] to 5 [excellent]) indicated proficiency. Secondary outcomes included initial vs final scores by country, scores among surgeons trained by the regional trainers (second-order trainees), interval scores 6 months after training, and postoperative complications. Results A total of 20 surgeon trainers, 81 local surgeons, and 364 patients (343 adult, 21 pediatric) participated in the study (mean [SD] age, 47.5 [16.3] years; age range, 16-83 years). All 81 surgeons successfully completed the program, and all 364 patients received successful operations. Mean (SD) OPRS scores improved from 4.06 (0.87) before the initial training program to 4.52 (0.57) after training (P < .001). No significant variation was found by country in final scores. On trainee certification, 20 became regional trainers. The mean (SD) OPRS score among 53 second-order trainees was 4.34 (0.68). After 6-month intervals, the mean (SD) OPRS score among participating surgeons was 4.34 (0.55). The overall operative complication rate during training series was 1.1%. Conclusions and Relevance Competency-based training helps address the global burden of surgical disease. The OPRS establishes an international standard of technical assessment. Additional studies of long-term surgeon trainer proficiency, community-specific quality initiatives, and expansion to other operations are warranted.

Prevention of Pain: Optimizing the Open Primary Inguinal Hernia Repair Technique

The prevention of pain requires that surgeons should take care not only during the entire surgical procedure but also before and after, following these steps: 1. Preoperative patient selection: preoperative pain, preoperative pain response to heat, intraoperative nerve injury, early postoperative pain intensity, younger age, and open surgery are risk factors for postoperative chronic pain. 2. Anesthesia: local anesthesia seems to be followed by less postoperative pain. 3. Approach: open anterior for all primary inguinal hernias. 4. Identification and respect of the three nerves when possible, otherwise pragmatic neurectomy. 5. Choice of the prosthesis: light- or medium-weight polypropylene flat mesh for “normal” patients. 6. Choice of fixation: sutureless or fibrin glue fixation should be advised. 7. Always provide proper postoperative therapy.