Comparison of mesh plug and prosthesis requiring dissection of preperitoneal space for inguinal hernia repair

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Original Contribution Kitasato Med J 2014; 44: 178-182 Comparison of mesh plug and prosthesis requiring dissection of preperitoneal space for inguinal hernia repair Eiichiro Watanabe, 1,2 Takumi Miyamoto, 1 Atsuo Tokuka, 1 Yoshimasa Kosaka, 2 Noriko Takeda 2 1 Department of Surgery, Shimane Prefectural Central Hospital 2 Department of Surgery, Kitasato University School of Medicine Objective: Hernioplasty is one of the most basic operative procedures in the field of general surgery. We evaluate our 5-year period of clinical experiences of inguinal hernia. Methods: Adult patients with hernioplasty from January 2006 through December 2010, in our department, were recruited for this study. In the first 4 years, we mainly performed the mesh plug technique (MPT); whereas in the last year, we mainly used the ULTRAPRO plugs and the ULTRAPRO Hernia System repair. Results were compared statistically using Fisher's exact test where values of P < 0.05 were considered significant. Results: In the 4 years from 2006 through 2009, hernioplasty was performed on 460 hernias. There were 122 (26.5%) postoperative complications, including 17 hematomas (3.7%) and 21 recurrent cases (4.6%). In 2010, hernioplasty was performed for 129 hernias. There were 22 (17.1%) postoperative complications, including 9 hematomas (7.0%), and 2 recurrent cases (1.6%). Conclusions: The use of heparin before surgery (P < 0.01) and prosthesis requiring dissection of preperitoneal space (P = 0.048) were risk factors for postoperative hematoma; in the case of direct hernia, the MPT was a risk factor for recurrence (P = 0.0036). Key words: inguinal hernia, mesh plug, hematoma, recurrence Introduction H ernioplasty is perhaps the most basic operative procedure in the field of general surgery. Since Edoardo Bassini reported his method in 1887, more than 70 operative techniques of hernioplasty have been described. 1 As technology has advanced, not only laparoscopic hernioplasty but also that using lightweight and large-pore meshes such as the ULTRAPRO plug (UPP) and the ULTRAPRO Hernia System (UHS) (Johnson & Johnson, Somerville, NJ, USA) have become more prevalent worldwide. Nowadays, there are regional differences in terms of hernioplastic operative procedures. We evaluated our clinical experiences of inguinal hernia repair to improve our clinical outcomes. Material and Methods Adult hernioplasties were performed in 532 cases for 589 hernias from January 2006 through December 2010 Table 1. Patient characteristics from 2006 through 2010 Variable Indirect Direct Concurrent Bilateral Femoral Recurrence Patients (male) 361 (313) 66 (59) 22 (19) 28 (27) 37 (4) 18 (17) Age (yrs) 63.2 ± 16.4 67.2 ± 12.3 70.5 ± 8.20 67.8 ± 10.2 76.2 ± 10.7 69.8 ± 14.0 Scheduled operations 355 65 22 28 19 18 Urgent operations 6 1 0 0 18 0 Operation time (min) 66.7 ± 16.4 63.2 ± 31.0 62.5 ± 10.5 96.8 ± 22.6 65.6 ± 20.0 85.7 ± 52.9 Hospital stay (days) 3.47 ± 0.77 3.51 ± 1.24 4.09 ± 2.09 4.63 ± 1.93 4.62 ± 2.33 3.94 ± 1.34 Received 16 January 2014, accepted 31 March 2014 Correspondence to: Eiichiro Watanabe, Department of Surgery, Kitasato University School of Medicine 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan E-mail: eiichiryoma@hotmail.com 178

Inguinal hernia repair in our department (Table 1). Surgical residents performed almost all of the operations while being supervised by general surgeons who each had 10 or more years of clinical experience in traditional hernia repair. Clinical cases in the first 4 years, when the mesh plug technique (MPT) and the modified Kugel patch (MK) were mainly used, were examined retrospectively regarding clinical characteristics, such as types of hernia and prosthesis, and postoperative complications. In the last year of this period, we reflected on our outcomes of the first 4 years and incorporated new prostheses, e.g., the UPP and the UHS. In all cases, the operation was performed with a 3.0 5.0-cm skin incision parallel to the inguinal ligament between the internal and external rings. After the inguinal canal was opened, the type of hernia was diagnosed according to the Japanese Hernia Society classifications (Table 2). Other than in urgent cases, we have mainly used the UPP in I-1 and I-2 cases and the UHS in I-3, II, and III cases (Table 2). In addition to this strategy, the MPT is available in cases in which dissection of the preperitoneal space is difficult due to adhesions, such as those from radiation therapy and postoperative conditions near the inguinal area. Heparin was administered preoperatively to the patients regularly using anticoagulants and antithrombotics. We examined these cases retrospectively, and the results were compared statistically using Fisher's exact test where P values of <0.05 were considered significant. We defined recurrence as inguinal reprotrusion, and hematoma as coagulated blood collection in tissue after surgery. Both of these were diagnosed by general surgeons. Results In the first 4-year period, hernioplasty was performed in 460 hernias in 422 cases. The types of hernia were: indirect in 293, direct in 50, concurrent in 12, bilateral in 22, femoral in 27, and recurrent in 16 (Table 3). Postoperative complications included: 8 wound dehiscences (1.7%), 17 hematomas (3.7%), 18 seromas (3.9%), 18 cases with postoperative pain (3.9%), and 22 Table 2. Hernia classifications of the Japanese Hernia Society (JHS) I Indirect hernia I-1 Mild (hernia orifice <1 cm) I-2 Moderate (hernia orifice <3 cm) I-3 Severe (hernia orifice 3 cm II Direct hernia II-1 Supravesical (hernia orifice <3 cm) II-2 Localized (hernia orifice <3 cm) II-3 Diffused (hernia orifice 3 cm III Femoral hernia IV Concurrent hernia V Specialized (none of the above) Recurrent hernia is categorized along with the JHS classification. Table 4. Postoperative complications from 2006 through 2009 Complication Number (%) SSIs 22 (4.8) Recurrence 21 (4.6) Postoperative pain 18 (3.9) Seroma 18 (3.9) Hematoma 17 (3.7) Wound dehiscence 8 (1.7) Discomfort 6 (1.3) Induration 6 (1.3) Mesh trouble 4 (0.9) Re-recurrence 2 (0.4) Total 122 (26.5) Table 3. Patient characteristics from 2006 through 2009 Variable Indirect Direct Concurrent Bilateral Femoral Recurrence Patients (male) 293 (253) 50 (46) 12 (11) 22 (22) 27 (1) 16 (15) Age (yrs) 63.2 ± 16.7 64.7 ± 12.9 73.8 ± 6.49 68.0 ± 10.3 76.3 ± 11.7 67.1 ± 79.1 Prosthesis mainly used MP MP MP MP MP - Scheduled operations 288 49 12 22 13 16 Urgent operations 5 1 0 0 14 0 Operation time (min) 58.9 ± 22.7 62.1 ± 33.0 62.8 ± 11.0 109 ± 28.6 45.3 ± 20.2 70.3 ± 106 Hospital stay (days) 3.58 ± 1.98 3.55 ± 1.35 4.25 ± 2.56 4.86 ± 2.48 7.84 ± 7.03 4.07 ± 1.39 179

Watanabe, et al. surgical site infections (SSIs) (4.9%). There were 21 recurrent (4.6%) and 2 re-recurrent (0.4%) cases in this period (Table 4). Regarding postoperative hematoma, univariate analysis revealed that the use of heparin before surgery (with heparin or without heparin = 7/26 or 10/ 396, respectively, P < 0.01) and prosthesis requiring dissection of preperitoneal spaces were risk factors of postoperative hematoma (P = 0.048). Moreover, in the aspect of recurrence, the use of the MPT for repair of direct hernia was a significant risk factor of recurrence (P = 0.0036). In the last year of the study period, hernioplasty was performed on 129 hernias in 112 cases. The types of hernia were: indirect in 68, direct in 16, concurrent in 10, bilateral in 6, femoral in 10, and recurrent in 2 cases (Table 5). Postoperative complications included: 1 wound dehiscence (0.8%), 2 seromas (1.6%), 2 cases of postoperative pain (1.6%), 6 SSIs (4.7%), and 9 hematomas (7.0%). There have been 2 recurrent cases since 2010 (Table 6). Discussion Hernioplasty remains to date one of the most basic operative procedures in the field of general surgery. The European Hernia Society recommended the Lichtenstein repair for inguinal hernias, which has been as widely used as in 60% of European cases and 30% of those in Table 5. Patient characteristics in 2010 Variables Indirect Direct Concurrent Bilateral Femoral Recurrence Patients (male) 68 (61) 16 (13) 10 (8) 6 (5) 10 (3) 2 (2) Age (yrs) 66.7 ±15.0 71.0 ± 9.47 66.5 ± 8.53 68.0 ± 10.3 75.7 ± 7.54 66.5 ± 8.50 Prosthesis mainly used UHS UHS UHS UHS UHS - Scheduled operations 67 16 10 6 6 2 Urgent operations 1 0 0 0 4 0 Operation time (min) 66.7 ± 16.4 66.4 ± 24.7 62.1 ± 10.4 102 ± 14.7 56.7 ± 14.0 74 Hospital stay (days) 3.47 ± 0.77 3.38 ± 0.86 3.90 ± 1.45 4.83 ±1.94 4.62 ± 2.33 3 Table 6. Postoperative complications in 2010 Complication Number (%) Hematoma 9 (7.0) SSIs 6 (5.4) Seroma 2 (1.6) Recurrence 2 (1.6) Postoperative pain 2 (1.6) Wound dehiscence 1 (0.8) Total 22 (17.1) Table 7. Clinical characteristics of recurrent cases Case Sex Age Hernia Prosthesis used Recurrent portion 1 M 56 Indirect MP Unknown 2 M 64 Direct MP Indirect hernia 3 M 58 Concurrent MP Pubic side 4 M 76 Concurrent MP Pubic side 5 M 79 Indirect MP Unknown 6 M 89 Concurrent MP Pubic side 7 M 64 Direct MP Pubic side 8 M 81 Indirect MP Unknown 9 M 69 Indirect MP Unknown 10 M 47 Indirect MP Femoral hernia 11 W 54 Direct MP Femoral hernia 12 M 59 Concurrent MP Pubic side 13 M 56 Direct MK Pubic side 14 M 65 Direct MP Unknown 15 M 77 Direct MK Unknown 16 M 80 Indirect MP Unknown 17 M 69 Direct MP Pubic side 18 M 65 Direct MP Unknown 19 M 76 Indirect MP Direct hernia 20 M 90 Direct MP Femoral hernia 21 M 73 Indirect MP Indirect hernia MP, mesh plug; MK, modified Kugel patch 180

Inguinal hernia repair the USA. 2 In Japan, on the other hand, the MPT has been the most common prosthesis for many decades. The Japanese Endoscopic Association reported that the MPT was used in 45% of cases in Japan, whereas the Lichtenstein repair is not as common. Many reports with regard to postoperative complications after inguinal hernia repairs have been published. The European Hernia Society reported that the total number of the postoperative complications was 15% 20% for all procedures and would likely exceed 17% 50% with a more detailed survey. Most common postoperative complications were hematoma (5.6% 16%), seroma (0.2% 12.2%), and wound infection (1.0% 3.0%). 2 Some reports regarding MPT revealed seroma (1.0% 3.7%), wound infection (0.2% 2.9%), and hematoma (3.5% 6.7%), 3,4 and of those regarding MK, seroma (2.1% 4.8%), hematoma (2.1% 2.3%), and wound infection (2.1% 2.3%) were described. 1,5 The recurrence rate exceeds 10% 15% in the conventional tension repairs, such as Bassini, iliopubic tract repair, and McVay repair; otherwise, it decreases 0.25% 3.4% in the field of the tension-free repair. 1 In our experience, the MPT for direct hernia repair has a risk factor of recurrence (P = 0.0036), and 7 of 12 (58%) recurrent cases in direct hernia showed a recurrent hernia sac on the pubic side (Table 7). This result may lead to the conclusion that, in cases using the MPT for direct hernia, it is important not only to dissect the supravesical portion correctly to detect the hernia sac but also to attain good preperitoneal placement of the plug, as its outer petals are best stretched and flattened, 6 followed by fixation of the on-lay mesh strictly to the pubic side to prevent recurrent hernia. Moreover, careful investigation of other types of hernias, such as femoral hernia, in every case is important. In addition, in cases using MK and UHS, it is essential not only to dissect the preperitoneal space carefully to prevent postoperative hematoma, but also to spread the pubic side of the underlay patch completely to prevent recurrence (Figure 1). Our department has adopted lightweight and largepore meshes, such as the UPP and UHS prostheses, since 2010 in order to improve our clinical outcomes with reflection on the first 4 years of the period in the present study. Many reports on lightweight and large-pore meshes have been published revealing that the mesh attaches to the tissues very gently and reduces postoperative discomfort. 7-9 Of course, both the UPP and the UHS are effective; but the MPT is still needed in cases in which the preperitoneal space is difficult to dissect, such as in patients after radiation therapy and with postoperative conditions close to the inguinal area such as those seen in patients with colon cancer or prostate cancer. With our new strategy, the total number of postoperative complications decreased from 26.5% (122/460) to 17.1% (22/129) and there have only been two recurrences since 2010. Moreover, the rate of postoperative hematoma decreased from 13.9% (5/36) to 7.1% (7/97) in cases in which dissection of the preperitoneal space was required. In direct hernia repair, the MPT is not recommended; however, the UHS and MK are feasible to prevent recurrent hernia. In addition, both using heparin preoperatively and dissecting the preperitoneal space carry risk factors of postoperative hematoma. Proper strategies with detailed studies in each facility are warranted and will lead to better clinical outcomes in inguinal hernia repair. A. The hernia orifice on the left side is not covered with an underlay patch because it does not spread correctly. Figure 1. Recurrent left direct hernia after modified Kugel patch repair 181 B. The underlay patch spreads correctly and covers the hernia orifice perfectly in the right direct hernia.

Watanabe, et al. References 1. Li J, Zhang Y, Hu H, et al. Early experience of performing a modified Kugel hernia repair with local anesthesia. Surg Today 2008; 38: 603-8. 2. Simons MP, Aufenacker T, Bay-Nielsen M, et al. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia 2009; 13: 343-403. 3. Dalenbäck J, Andersson C, Anesten B, et al. Prolene Hernia System, Lichtenstein mesh and plug-andpatch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial. The BOOP study: bi-layer and connector, on-lay, and on-lay with plug for inguinal hernia repair. Hernia 2009; 13: 121-9. 4. Bringman S, Ramel S, Heikkinen TJ, et al. Tensionfree inguinal hernia repair: TEP versus mesh-plug versus Lichtenstein: a prospective randomized controlled trial. Ann Surg 2003; 237: 142-7. 5. Kurihara Y, Yamakawa T, Yoshino M, et al. Experience with direct Kugel patch method for repair of adult inguinal hernia. J Nippon Med Sch 2008; 75: 28-31. 6. Frost BM, Hilton J, Stephenson BM. Millikan KW, Doolas A (2007) A long-term evaluation of the modified mesh-plug hernioplasty in over 2,000 patients. Hernia 2008; 12: 327-8. 7. Khan LR, Kumar S, Nixon SJ. Early results for new lightweight mesh in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia 2006; 10: 303-8. 8. Polish Hernia Study Group1, Smietański M. Randomized clinical trial comparing a polypropylene with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty. Br J Surg 2008; 95: 1462-8. 9. Khan LR, Liong S, de Beaux AC, et al. Lightweight mesh improves functional outcome in laparoscopic totally extra-peritoneal inguinal hernia repair. Hernia 2010; 14: 39-45. 182