L. D’Amore

Long-term discomfort after plug and patch hernioplasty

collected 5 years after hernioplasty by an expert in locating people. Of 839 patients, 764 (91%) were contacted by a physician and answered a telephone questionnaire. Only 75 patients were lost at follow-up because of change of address. Among the more important questions were: Do you feel any painful sensation? Do you feel anything abnormal in the groin? Do you have any recurrence or any other symptom? All patients (119 of 764) complaining of any sign consistent with discomfort or painful sensation throughout the groin attended a physical examination by an independent surgeon, with experience in hernia surgery. As in the study of Berndsen, the importance of pain was graduated as mild (occasional discomfort or pain that does not interfere with daily activity), moderate (discomfort or pain that occasionally interferes with daily activity) and severe (discomfort or pain that interferes with daily activity). Results are shown in Table 1. At physical examination, 19 of 24 patients turned from moderate to mild. Overall discomfort after 5 years was 6.5%, with only 0.9% of patients complaining of moderate (0.6%) or severe (0.3%) pain. We found no relationship between late discomfort and early postoperative pain. On the contrary, a correlation with preoperative pain was evidenced, but it was not statistically signiWcant. Our results from this large series, with high follow-up percentage (91%) and supplemental physical examination after 5 years, have demonstrated that the incidence of late discomfort after plug and patch hernioplasty is as low as it is for the TAPP procedure in Berndsen’s study. Our present purpose is not to compare late results of plug and patch repair with that technique but to stress that the true incidence of long-term discomfort after prosthetic hernioplasty could not be as high for all well-standardised techniques as believed.

Bioabsorbable Gore BIO-A plug and patch hernia repair in young adults

We read with great interest the report by Efthimiou et al. [1] on plug and patch hernia repair using a polyglycolic acid-trimethylene carbonate mesh. The purpose of this pilot study (ten patients with direct and indirect inguinal hernia with a mean age of 65.6 years) was to evaluate the efficacy of using a totally absorbable device (Gore BIO-A Tissue Reinforcement patch and Gore BIO-A plug), looking primarily at recurrence and chronic pain assessed 1 year after the operation. The authors stress, and we agree with, that an ideal mesh for inguinal hernia repair should cause the minimum foreign body reaction. Moreover, the excessive local inflammatory reaction that occurs when a polypropylene (PP) mesh, especially heavyweight PP, is implanted, may cause prosthetic shrinkage and chronic pain. For these reasons, surgeons would consider the use of PP with different characteristics (low-weight large porous PP, PP/polyglactine composite, PP with polytetrafluorethylene surface) or other materials as polyvinyliden fluoride (PVDF). Gore BIO-A mesh is made of a biocompatible synthetic polymer. Its design structure (with open highly interconnected pores) creates a scaffold that facilitates tissue generation, mimicking native collagen fibres. This material is fully absorbed in approximately 6 months. At 1 year follow-up, none of the patients from Efthimiou’s study had clinical signs of recurrence. Only one patient experienced intermittent pain without the need for any medication. On the other hand, the authors do not highlight any protective role on the vas deferens that could possibly be played by Gore BIO-A plug and patch repair, probably because all patients in their study were elderly. Many experimental studies in animals have shown that PP mesh can adversely affect spermatic cord structure and/ or function [2–5]. On the contrary, little clinical information is available regarding the long-term effects of PP mesh on the vas deferens. One possible reason is that most men undergoing hernia repair tend to be elderly, and thus not so concerned about maintaining their reproductive potential. However, a multiinstitutional experiment and some casereports [6–8] have confirmed the potential risk of injury when a PP mesh is placed in contact with the bare vas deferens, as in the case of plug and patch repair. PP herniorraphy is being offered to young adults whose fertility status will be an issue in the future. At present, we are unable to determine whether PP mesh will result in an higher incidence of inguinal vasal obstruction and infertility. In 2009, we began a prospective multicentre study on the use of BIO-A prosthesis in young adults (maximum age 45 years) to try to answer these questions, and to offer a safer repair to patients. Only primary indirect (L, lateral, according to EHS’s classification) hernias were included in the study. All patients underwent open plug and patch repair. C-reactive protein (CRP) samples were collected to estimate the inflammatory response. Pain was evaluated using VAS score, and quality of life status by the SF-36 system. Mid-term results (at 2 years) will be published soon. In the meantime, we wish to point out that, at 18-month follow-up, none of the 15 patients enrolled by our Centre had any complications and all patients were totally satisfied. We can also assume that no adverse events affected the cord structure. P. Negro (&) F. Gossetti M. R. Dassatti J. Andreuccetti L. D’Amore Department of General Surgery ‘‘P. Stefanini’’, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy e-mail: pal.negro@libero.it

Selective use of bioabsorbable Gore BIO-A plug and patch for groin hernia repair

We read with great interest the report by Symeonidis et al. on long-term results of a pilot study on plug and patch hernia repair using a fully absorbable mesh (polyglycolic acid/trimethylene carbonate—Gore BIO-A) [1], previously described [2]. At the 3-year follow-up, clinical examination revealed recurrence in three out of the eight patients (37.5 %). We agree with the authors when affirming that this result represents a crucial finding requiring appropriate critical interpretation. In 2009, we started a prospective multicentre study on the use of BIO-A plug and patch in groin hernia repair, as announced in a previous note [3]. In our study, the rationale for the use of BIO-A was the reduction of the potential risk of injury when a polypropylene (PP) mesh is placed in contact with the bare vas deferens, as in the case of plug and patch hernia repair; the goal was the evaluation of any higher long-term recurrence rate. On a pilot basis, we enrolled 15 young adults (\45 years), including only primary lateral (L-lateral according to EHS’s classification) hernias. At surgery, the hernia was classified as L1, L2 and L3 in 5, 8 and 2 cases, respectively. All patients underwent clinical examination 18 months after the procedure (medium term results). None of them presented any complication and all patients were totally satisfied. After 30 months (long-term follow-up), patients were contacted again. Two of them moved to a new address and for this reason were invited to a telephone interview. All the remaining patients were submitted to clinical examination. A recurrence was clinically diagnosed in two cases (2 patients aged 45, with L3 hernia), both revealing a medial (M) hernia at reoperation. No patient without recurrence complained foreign body sensation or pain, including the patients undergoing telephone inquiry. The recurrence rate in our study has proved to be three times lower than in Symeonidis et al.’s study (13 vs. 37.5 %). We believe that this might be due to two reasons. The first concerns the patients’ selection (different study design). In fact, Symeonidis et al. enrolled patients irrespective of the hernia type, lateral or medial, and of the age. Conversely in our study, we selected only patients aged\45, with lateral hernias. The second reason is related to the surgical technique. Symeonidis et al. finally restored the anatomy of the inguinal canal by closing the external oblique aponeurosis superficially to the spermatic cord. In our procedure, the external oblique aponeurosis was placed dorsally to the cord, as we routinely perform in all inguinal hernia repair. The adoption of these parameters by Symeonidis et al. could have probably reduced their recurrence rate to our values. Despite this, the incidence of 13 %, we have registered, appears unacceptable and requires a critical update. Based on the results of our pilot study, it seems that the polyglycolic acid/trimethylene carbonate absorbable mesh (Gore BIO-A Tissue Reinforcement ) patch cannot guarantee a solid reinforcement of the posterior wall of the inguinal canal, or prevent a medial hernia. Current data This comment refers to the article available at doi: 10.1007/s10029-012-1016-0.

Mesh plug repair: can we reduce the risk of plug erosion into the sigmoid colon?

We read with great interest the article by Yilmaz et al. [1], presenting a case-report of mechanic bowel obstruction in a patient previously submitted to left inguinal hernia repair with mesh plug technique. During surgery, it was found that the plug was migrated into the sigmoid mesentery, thus occluding the sigmoid colon. Mesh plug repair (MPR) is a worldwide largely used technique mostly for the treatment of lateral groin hernia. The main criticism to MPR is that the plug can migrate and/or erode the surrounding structures. The 3-D rigid structure and the profile of the plug may be responsible for this complication even if it may occasionally complicate flat mesh preperitoneal hernia repair (such as Stoppa’s, Prolene Hernia System or laparoscopic repair). Since 1997, our literature database has collected 2 coecum [2, 3] and 5 left colonic involvement after plug repair [4–8]. The case-report by Yilmaz and a personal case (a 70 year-old patient with plug erosion into the sigmoid colon 9 years later a MPR, requiring sigmoidectomy) should be added to these. It is important to underline that 5 of 7 patients (mean age, 71) suffered from diverticular disease. This fact can suggest that diverticular inflammation might cause attraction of the plug with consequent erosion into the colon. Probably other cases of plug migration did not come to publication for medico-legal implications, indifference of authors or lack of recognition and the rate therefore could be underestimated. Can we avoid this risk? Some authors believe that lack of fixation of mesh plug predisposes to its migration [9], but other technical details could also contribute to reduce this complication, such as to avoid the excision of the sac, identify and repair any hole in the peritoneal sac, use preshaped devices, choose the proper size and light material. When dealing with aged patients suffering from left inguinal hernia and colonic diverticular disease, we suggest to consider avoiding plug repair and preferring the Lichtenstein procedure.

Abdominal wall reconstruction (AWR): the need to identify the hospital units and referral centers entitled to perform it

Criteria to identify hospital units and referral centers in Italy entitled to perform major general surgery, such as esophageal, hepato-pancreatic and colo-rectal surgery were recently proposed [1]. The role of indicators of effectiveness and quality of care, and dramatic innovations in modern surgical subspecialty concur with this proposal [2]. Furthermore there is a robust evidence of improved outcomes of patients treated by specialist multidisciplinary teams. Abdominal wall reconstruction (AWR) for primary or incisional hernia remains a challenging problem for primary care physicians, surgeons, and patients. Cochrane collaboration places the number of AWRs performed in Europe at about 400,000/year and at 300,000/year in USA [3]. In USA this number is expected to increase of 11,000 procedures each year in the near future. Taking into account the number of repairs performed in 2006, the total estimated procedural cost for AWR was US

Comment to “Long-term outcomes (>5 year follow-up) with porcine acellular dermal matrix (Permacol™) in incisional hernias at risk for infection” by Abdelfatah MM, Rostambeigi N, Podgaetz E, Sarr MG (DOI 10.1007/s10029-013-1165-9)

3.2 billion [4]. We personally calculated that 40,000 AWRs (ICD-9 procedural code 53.51, 53.61, 53.59, 53.69) were performed in Italy in 2014 with an estimated cost of 200 million euro, without taking in account economic costs to society including time lost for work and chronic disability (associated with hernias). Approximately a quarter of all incisional hernia repairs needs a reoperation, even with the use of meshes, and the recurrence exponentially increases with subsequent repairs [5]. This could cause significant further rises in healthcare costs mainly if technologically advanced meshes or biologic implants are required [6]. In USA each 1% reduction in hernia recurrence would result in a US

Lichtenstein repair of inguinal hernia: fibrin glue or suture for mesh fixation?

32 million yearly savings in procedural cost alone. Moreover, other complications, such as surgical site occurrence (SSO), mainly the surgical site infection (SSI), length of hospital stay and quality of life should be taken in account. The cost for an outpatient AWR rises from US

Mesh plug and Lichtenstein patch repairs at 12 months follow-up: no differences in outcome

16,000 to 65,000 and 82,000, in cases of SSI and mesh infection, respectively [4, 7, 8]. Over the last 20 years a great number of innovations both in operative techniques and technologies have revolutionized surgical treatment. New reconstructive procedures, including component separation, gained popularity with the additional potential benefit of restoring functionality of the abdominal wall. Furthermore, laparoscopic ventral hernia repair (LVHR) improves patient-centered outcomes and represents a viable option in selected cases [9]. Mesh repair significantly reduces the number of recurrences but it needs a strong knowledge of the characteristics of devices, more and more largely proposed on the market [10–12]. Careful matching of patient characteristics and surgical techniques in the choice of prosthetics could minimize postoperative complications and readmissions [13]. In conclusion, it seems inevitable that surgeons are specializing in abdominal wall surgery to an increasing extent [5]. Are AWRs ‘‘complex’’ enough to warrant hospital units and referral centers entitled to perform them? Despite the development of prosthetic techniques, results following abdominal hernia repair are not so good as expected, in term of recurrence and wound complications. Numerous factors should be taken in account, including that in several cases of ventral hernia the best technique and the proper device have not been utilized [5]. This principally happens in case of complex abdominal wall hernias, when clear criteria of & Francesco Gossetti gossetti@tiscalinet.it

Mesh plug repair and surgeon’s satisfaction

We read with great interest the article by Abdelfatah et al. titled ‘‘Long-term outcomes ([5 year follow-up) with porcine acellular dermal matrix (Permacol) in incisional hernia at risk for infection’’ [1]. This retrospective study included 65 consecutive patients, who underwent abdominal wall reconstruction (AWR) with porcine acellular dermal matrix (PADM) for repair of incisional hernias at high risk for surgical site infection (SSI). The surgical wound was clean in 49 %, clean-contaminated or contaminated in 45 % and infected in 6 % of cases. At the end of the study, authors concluded the use of Permacol PADM is far from ideal to unsatisfactory in the overall picture. Only in selected patients its use might prove to be useful. In fact, results from Abdelfatah et al. are discouraging and PADM as bioprosthesis for ventral hernia appears unreliable as definitive repair at this time. In Abdelfatah series, SSI occurred in 20 % within 30 postoperative days and in 37 % after this period (with 25 % of PADM infection). Infection required subtotal or total removal of PADM in 15 cases. Fifty-nine patients with a follow-up C5 years displayed overall recurrence in 66 %, documented at physical examination or objective findings (CT scan or reoperation). Why these bad results? authors have full knowledge of some limitations of their study, including the heterogeneous differing types of repair, onlay, inlays and sublays with bridging (patches) or reinforcement by the PADM. We absolutely agree with them and we believe that the explanation of such discouraging results actually must be sought in the surgical technique. Abdelfatah et al. report that a bridging patch repair was performed in 31/65 patients, an onlay or intraperitoneal reinforcement of an autogenous suture repair in 28/65 and an inlay repair in 6/65. PADM was never placed as a sublay in the retromuscular space, as described by Rives and Stoppa [2, 3]. Results from our experience are different. Between July 2005 and December 2013, 45 consecutive patients underwent abdominal wall reconstruction (AWR) with PADM (32 with Permacol, Covidien and 13 with CollaMend, Bard, Davol) for incisional hernias. Four patients needed more than one implant, due to concomitant hernias in other sites (parastomal or perineal), for a total number of 50 implants. All patients were at risk of infection, 87 % of them displaying grade III, according to mod.WVHG (Table 1) [4]. In 86 % of implants, PADM was used as augmentation repair while in 14 % of them sublay bridging repair was performed (Table 2). Sixty-eight percent of defects were treated with primary suture of the midline and retromuscular PADM reinforcement (Rives–Stoppa technique). When ventral rectus sheaths could not be reapproximated, techniques of posterior components separation were performed [5, 6]. All patients were collected in a database and examined every year. The presence or absence of recurrent hernias was documented by cross-sectional imaging (CT scan or MRI) with Valsalva manoeuvre. Our short-term SSI rate was quite similar to Abdelfatah et al. (26 vs. 20 %), despite the higher risk of infection in our patients (87 vs. 50 %). In our series, one patient died due to sepsis on 30th postoperative day. Long-term SSI was demonstrated in 2 cases (4 %), both belonging to the This comment refers to the article available at doi:10.1007/s10029013-1165-9.

Teaching Hernia Surgery: The Experience of the Italian School

First of all, we wish to thank Tripoloni and Schierano [1] for the attention they paid to our trial comparing fibrin glue versus suture for open tension-free Lichtenstein hernia repair [2]. We appreciate their interest in the details. We agree that the two groups may have included subgroups that could cause bias, but we have to remember that this was a prospective observational multicenter study. The study was not randomized or blinded and, for this reason, no formal power calculations were undertaken. This is what happens with observational studies (cohort studies) which, for this reason, reach the level of evidence 2B with grade of recommendation B. Nonetheless, they can provide interesting results or suggestions for clinical practice. In our study, fewer patients in the fibrin glue group reported pain, numbness, and discomfort compared with patients in the sutures group at 1 month, and this occurred until the third month, when all differences disappeared, with the exception of numbness, which continued to be more prevalent in the sutures group. Tripoloni and Schierano [1] noted that the difference in pain intensity in favor of fibrin glue is not clinically meaningful. We agree with this, but the fact remains statistically meaningful. Anyway, in the literature, comparisons among different techniques for hernia repair, i.e., open versus laparoscopic repair, are often based on little variation in terms of mild or mild moderate pain. In our study, the mean operating time was reduced by 9% in the fibrin glue group compared to the sutures group. Although this value is statistically meaningful, Tripoloni and Schierano [1] believe that 6 min for each procedure is of little practical importance. We wish to underline that our study included 16 centers with extensive experience in hernia surgery. In less expert hands, i.e., residents and young surgeons, this saving of time is probably greater, with economic advantages. Of greater importance seems to be the remark on the risk of recurrence and that fibrin glue should expose to higher recurrence risk if compared to the sutures group. Actually, the two recurrences in our study occurred in the first group and in patients with direct hernias (type M) (more numerous in the fibrin glue group for the lack of stratification). We revised the files of both patients that were re-operated for recurrence. In both cases, a mesh of inadequate size was used. Both hernias recurred distally to the mesh, close to the pubic tubercle, type M1. The letter by Tripoloni and Schierano [1] provides us the opportunity to stress the importance of using a mesh of sufficient size to overlap the pubic tubercle, as requested also when a tension-free suture Lichtenstein repair for direct hernia is performed. With this solution, the difference in the recurrence rate between the two techniques nullifies. We, together with all the co-workers in our study, continue to believe that, in the future, the use of fibrin or synthetic glue for mesh fixation or self-gripping meshes will probably replace sutures in groin hernia repair.