Francesco Gossetti

A Western single-center experience with endoscopic submucosal dissection for early gastrointestinal cancers

Endoscopic submucosal dissection (ESD) has gained worldwide acceptance as a treatment for early gastrointestinal cancers (EGICs). However, the management of these tumors in the Western world is still mainly surgical. Our aim was to evaluate the safety and feasibility of ESD at a European center. Based on the knowledge transferred by one of the most experienced Japanese institutions, we conducted a pilot study on 25 consecutive patients with EGICs located in the esophagus (n = 3), stomach (n = 7), duodenum (n = 1), and colon (n = 14) at our tertiary center over a 2-year-period. The main outcome measurements were complete (R0) resection, as well as en-bloc resection and the management of complications. The R0 and en-bloc resection rates were 100% and 84%, respectively. There were three cases of bleeding and five cases of perforation. With a median follow up of 18 months, two recurrences were observed. We conclude that ESD for early esophageal and gastric cancers is feasible and effective, while colonic ESD requires more expertise.

Italian Biological Prosthesis Work-Group (IBPWG): proposal for a decisional model in using biological prosthesis

IntroductionIndications for repair of abdominal hernia are well established and widely diffused. Controversies still exist about the indication in using the different prosthetic materials and principally about the biological ones.Material and methodsIn February 2012, the Italian Biological Prosthesis Work-Group (IBPWG), counting a background of 264 biologic implants, met in Bergamo (Italy) for 1-day meeting with the aim to elaborate a decisional model on biological prosthesis use in abdominal surgery.ResultsA diagram to simplify the decisional process in using biologics has been elaborated.ConclusionThe present score represents a first attempt to combine scientific knowledge and clinical expertise in order to offer precise indications about the kind of biological mesh to use.

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

The Italian Register of Biological Prostheses

Background: A wide variety of meshes are available for surgical treatment of abdominal wall defects. These meshes are constructed with different materials with different biological properties. Methods: A prospective database was instituted (January 2009-December 2010) to register biological prostheses (BPs) implanted in Italy. Results: A total of 193 cases were registered. The mean age of the patients was 53.1 years (SD ±7.4). The ratio of males to females was 1.3 to 1. The mean body mass index was 28.2 (SD ±4.1). The breakdown of American Society of Anesthesiologists (ASA) scores was as follows: ASA I, 35.7%; ASA II, 27.5%; ASA III, 31.6%, and ASA IV, 5.2%. For ventral-incisional hernias, the mean duration of surgery was 101.1 min (SD ±25.3), while for inguinal-femoral hernias it was 49.2 min (SD ±19.1). The rate of urgent procedures was 36.7%. The surgical field was clean in 57.4% of cases, clean-contaminated in 21.3%, contaminated in 12.3% and dirty in 9%. Techniques used for inguinal-femoral hernias were as follows: Lichtenstein in 66.7%, plug and mesh in 3.8%, transabdominal-preperitoneal in 25.7% and intraperitoneal onlay mesh in 3.8%. The following prostheses were used: swine intestinal submucosa in 54.9%, porcine dermal collagen in 39.9% and bovine pericardium in 5.2%. In 45.1% of cases the prostheses were cross-linked. Techniques used for ventral-incisional hernias were as follows: onlay in 3.6%, inlay in 5.5%, sublay in 62.7% and underlay via laparoscopy in 28.2%. The mean overlap was 4.1 cm (SD ±1.2). No intestinal anastomosis was necessary in 65.3% of cases; however, small/large bowel resection and anastomoses were necessary in 22.3 and 12.4% of cases, respectively. Intraoperative blood transfusion was necessary in 10.4% of procedures. The skin was completely closed in 84% of procedures. At the 1-month follow-up, there were no complications in 54.4% of cases. Among the cases with complications, 10 patients (5.8%) experienced recurrence, and the postoperative readmission rate was 12.9%. The average visual analog scale (VAS) score for pain was 2.9 (SD ±1.2) at rest. At the 1-year follow-up, there were no complications in 96.4% of cases. Two patients experienced recurrence, and the postoperative readmission rate was 3.6%. The average VAS score for pain was 1.8 (SD ±0.8) at rest. Conclusions: This register shows that BPs are highly versatile and can be used in either open or laparoscopic surgery in all kinds of patients and in contaminated surgical fields. However, due to the very good outcomes of synthetic meshes and the high costs of BPs, the latter should only be used in selected cases.

Low anterior resection versus abdominoperineal excision: A comparison of local recurrence after curative surgery for “very low” rectal cancer

In the controversy regarding whether sphinctersaving resection (SSR) or abdominoperineal resection (APER) is more appropriate for the treatment of very low rectal cancer, local recurrence rates seem to play a fundamental role in patient outcome. In order to operate an effective patient selection, very low rectal cancer is defined herein as being located within 4.5 to 7.5 cm from the anal verge. This retrospective report investigates the incidence of local recurrence after curative surgery for very low rectal carcinoma in 24 consecutive patients treated by the same surgical team over a 15-year period using the above surgical procedures. In the APER group, the local recurrence rate was 45.5%, occurring in 5 of 11 cases; and in the SSR group 46.1%, occurring in 6 of 13 cases, with no significant difference between the two groups. Recurrence was found within one year of surgical treatment in all except one case. Despite the strict follow-up program, it was only possible to perform reoperation in two recurrent cases, both previously submitted to SSR and diagnosed by means of transanal ultrasonography and macrobiopsy. The high incidence of local recurrence in this series is explained by the advanced stage of disease in the majority of cases. Thus, as the choice between APER and SSR does not seem to affect the incidence of local recurrence, which is related more to tumor size, site, stage, and grading, preservation of the sphincters and restoration of digestive continuity should be achieved whenever technically possible.

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