Surg Today DOI 10.1007/s00595-014-0967-4
ORIGINAL ARTICLE
Single-incision totally extraperitoneal inguinal hernia repair: our initial 100 cases and comparison with conventional three-port laparoscopic totally extraperitoneal inguinal hernia repair Masaki Wakasugi • Toru Masuzawa • Mitsuyoshi Tei • Takeshi Omori • Shigeyuki Ueshima Masayuki Tori • Hiroki Akamatsu
•
Received: 29 March 2014 / Accepted: 25 May 2014 Ó Springer Japan 2014
Abstract Purpose To compare the outcomes of single-incision laparoscopic surgery for totally extraperitoneal inguinal hernia repair (SILS-TEP) and conventional three-port totally extraperitoneal (TEP) repair. Methods We performed a retrospective analysis of 137 patients (SILS-TEP, 100; conventional TEP, 37) scheduled to undergo elective inguinal hernia from January 2011 to July 2013 at Osaka Police Hospital. Results There were no significant differences in the patient demographics. There were no significant differences in the length of the operation between the two groups (SILS-TEP group, 93 min vs. conventional TEP group, 92 min for unilateral hernias, p = 0.8; SILS-TEP group, 142 min vs. conventional TEP, 128 min for bilateral hernias, p = 0.4). The postoperative hospital stay, total medical charge for the hospital stay and the numerical rating scale before and 3 months after surgery were comparable in both groups. Two cases treated by SILS-TEP repair were converted to conventional three-port TEP repair (one case) and mesh-plug method (one case). The postoperative complications were comparable in both groups, and these were managed conservatively. One recurrence (2 %, 1/37) developed in the conventional TEP group, compared with 0 recurrences (0/100) in the SILS-TEP group. Conclusions SILS-TEP repair seems to be safe and feasible, with no significant differences in the total medical charges for the hospital stay or the postoperative pain score
3 months after surgery compared with conventional threeport TEP repair. Keywords Single-incision laparoscopic surgery (SILS) Totally extraperitoneal repair (TEP) Inguinal hernia
Introduction Inguinal hernia repair is the most frequently performed operation in general surgery. In addition to the tension-free repair [1] described by Lichtenstein in 1989, which significantly reduced the recurrence rates, the two most common laparoscopic techniques for the treatment of inguinal hernia, totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repairs, have also revolutionized the general surgical field [2]. The laparoscopic approach offers advantages in terms of less postoperative pain and a faster recovery, with a low incidence of recurrence. In the last few years, SILS has been introduced to further improve the surgical outcomes and cosmetic results. The first case of SILS-TEP repair was reported in 2009 [3], but relatively few descriptions and comparisons with the conventional three-port TEP have been published to date [4–6]. In this report, our results with SILS-TEP repair are presented, and the outcomes for SILS-TEP and conventional TEP repair are compared.
Materials and methods M. Wakasugi (&) T. Masuzawa M. Tei T. Omori S. Ueshima M. Tori H. Akamatsu Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Ten-nouji-ku, Osaka 543-0035, Japan e-mail: [email protected]
Patients We performed a retrospective analysis of adult patients scheduled for SILS-TEP or conventional three-port TEP
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Surg Today Fig. 1 a The appearance of the Lap-Protector Mini in the incision. b The three ports secured to the EZ Access for the operation
inguinal hernia repair from January 2011 to November 2013 at Osaka Police Hospital. A total of 137 patients (SILS-TEP, 100; conventional TEP, 37) were evaluated. Until September 2011, we had performed the conventional three-port TEP repair method, but thereafter, we consecutively performed SILS-TEP repair [7, 8] for all patients undergoing laparoscopic inguinal hernia surgery. The patients with the following conditions were excluded from undergoing both procedures: patients with a previous history of radical prostatectomy; those with a recurrent hernia who had previously undergone preperitoneal hernia repair, such as the PHS repair [9, 10] or the Kugel repair [11] and patients who were not suitable for general anesthesia. Surgical technique Under general anesthesia with a transversus abdominis plane block, the patient was placed supine with both arms adducted. The patient was placed in the Trendelenburg position with the side contralateral to the hernia site tilted down. A single 25-mm subumbilical incision was made, followed by dissection of the subcutaneous tissue down to the rectus abdominis sheath. The anterior sheath was opened with an incision approximately 3 cm in length, and blunt dissection using a finger or gauze was performed between the muscle and the posterior sheath to create a preperitoneal space. Until April 2013, a single port access device (EZ Access; Hakko Co., Ltd., Nagano, Japan), through which three trocars (one 10-mm for a 10-mm flexible scope and two 5-mm) were inserted, and it was used to maintain the inflation of the preperitoneal space with carbon dioxide (CO2) gas, after a Lap-Protector Mini (Hakko Co., Ltd) was placed in the incision [9]. Thereafter, three 5-mm trocars for a 5-mm flexible scope were used (Fig. 1). In the SILS-TEP repair, the preperitoneal space was dissected gradually using conventional laparoscopic instruments without a dissection balloon. The conventional TEP repair was performed with three midline ports (one
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Fig. 2 The postoperative scar 3 months after SILS-TEP repair for bilateral inguinal hernias
10-mm port for a 10-mm flexible scope and two 5-mm ports with a skin incision of 17 ± 8 mm 9 2 = approximately 33 mm in length total) after the dissection of the preperitoneal space under the midline from the subumbilical incision using the 10-mm flexible scope. A polypropylene mesh (3D Max LightÒ; C. R. BARD, Murray Hill, NJ, USA) was placed in this preperitoneal space, covering the inguinal floor, and fixation of the mesh was performed by the application of three absorbable tacks (AbsorbaTackTM; Covidien, Mansfield, MA, USA) at the pubic bone, at Cooper’s ligament and above the iliopubic tract. After completion of the operation, the preperitoneal space was deflated with care to avoid displacing the mesh. The anterior rectus sheath was closed with a 2-0 Vicryl suture, and the skin was closed with a 3-0 PDS suture (Fig. 2). The medical costs of the devices used for the two procedures were approximately 420 US dollars in the SILSTEP repair and 220 US dollars for the three-port TEP repair, respectively, with the approximately 200 US dollars higher for the SILS-TEP being due to the EZ Access and Lap-Protector Mini. The patients routinely took loxoprofen at 180 mg/day, rebamipide at 300 mg/day and cefcapene
Surg Today
pivoxil at 300 mg/day orally for 3 days from the first postoperative day.
Table 1 The characteristics of the patients and hernias Characteristics
SILS-TEP (n = 100)
Conventional TEP (n = 37)
p value
Age (years)
65 ± 12
61 ± 14
0.1
Male sex
87 (87)
34 (92)
0.6
BMI (kg/m2)
23 ± 3
24 ± 3
0.1
Median ASA (range)
2 (1–3)
2 (1–3)
0.8
Unilateral
88 (88)
32 (86)
0.8
Bilateral
12 (12)
5 (14)
0.8
36 (36)
11 (30)
0.5
Indirect hernia
75 (75)
31 (84)
0.4
Femoral hernia
3 (3)
0
0.6
Recurrent hernia
5 (5)
0
0.3
Scrotal hernia
1 (1)
1 (3)
0.4
Incarcerated hernia
0
0
1
Data collection The patients’ age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, site and type of hernia, length of operation, blood loss, postoperative hospital stay, medical charges for the hospital stay, follow-up duration, numerical rating scale (NRS) scores before and 3 months after surgery, postoperative complications, conversion to a different procedure and hernia recurrence were recorded. Pain was measured using an 11-point pain intensity NRS, where 0 = no pain and 10 = worst possible pain before and 3 months after surgery. Some patients were followed-up by phone calls, but for patients not available by phone, the last follow-up findings were used in the analysis. The results are expressed as the mean ± SD or numbers (percentages). Statistical analysis Student’s t test, Fisher’s exact probability test and the Mann–Whitney U test were used for the analysis of parametric and non-parametric data, as appropriate. The paired t test was used to analyze the NRS scores before and 3 months after surgery. Differences at p \ 0.05 were considered to be significant. All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for the R software program (The Foundation for Statistical Computing); more precisely, it is a modified version of R commander designed to add statistical functions frequently used in biostatistics [12].
Results The patients’ demographic data are shown in Table 1. There were no significant differences between the two groups with regard to the patient and the inguinal hernia characteristics. The recurrent hernias in the SILS-TEP group included two cases of recurrence after mesh-plug repair and three cases repaired without mesh. The perioperative data for the SILS and conventional TEP repair groups are summarized in Table 2. The mean length of the operation for a unilateral hernia in the SILS-TEP and conventional TEP groups was 93 ± 26 min (range 41–204 min) and 92 ± 29 min (range 55–166 min), respectively (p = 0.8). The mean length of the operation for bilateral hernias in the SILS-TEP and conventional TEP groups was 142 ± 28 min (range 102–182 min) and
Site of hernia
Type of hernia Direct hernia
The data are given as the mean ± SD or number (%), unless otherwise specified SD standard deviation, BMI body mass index, ASA American Society of Anesthesiologists
128 ± 36 min (range 88–173 min), respectively (p = 0.4). The blood loss was minimal in all cases. The mean postoperative hospital stay in the SILS-TEP and conventional TEP groups was 3.3 ± 1.0 days (range 1–7 days) and 3.4 ± 1.3 days (range 1–7 days), respectively (p = 0.9). The total medical charges for the hospital stay in the SILS-TEP and conventional TEP groups were 5800 ± 700 US dollars (range 4300–7700 dollars) and 5700 ± 700 US dollars (range 4700–7500 dollars) (p = 0.2). The mean follow-up period was 15 ± 7 months for the SILS-TEP cases and 29 ± 8 months for the conventional TEP cases, which was significantly shorter in the SILS-TEP group than in the conventional TEP group (p \ 0.05). The NRS score at 3 months after surgery was significantly lower than the NRS score before surgery in both groups (p \ 0.05), but there were no significant differences between the two groups before and 3 months after surgery. Postoperative complications were seen in 11 % (11/100) of the patients in the SILS-TEP group and 5 % (2/37) of the patients in the conventional TEP group (p = 0.5). A seroma was seen in 11 % (11/100) of the patients in the SILSTEP group and 2 % (1/37) of the patients in the conventional TEP group (p = 0.2). A hematoma in the umbilical wound was seen in 2 % (1/37) of the patients in the SILSTEP group and 0 % (0/100) of the patients in the
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Surg Today Table 2 The perioperative data for the SILS and conventional TEP repair groups Variable
SILS-TEP (n = 100)
Conventional TEP (n = 37)
p value
Length of operation 93 ± 26
92 ± 29
0.8
Bilateral (min) Blood loss
Unilateral (min)
142 ± 28 Minimal
128 ± 33 Minimal
0.6 –
Postoperative hospital stay, days
3.3 ± 1.0
3.4 ± 1.3
0.9
Medical charge for hospital stay, dollars
5800 ± 700
5700 ± 700
0.2
Follow-up duration, months
18 ± 7
32 ± 8
\0.05
Numerical rating scale Before surgery
2.8 ± 2.9
2.6 ± 3.0
0.8
3 months after surgery
0.4 ± 1.0
0.2 ± 0.9
0.3
Complications
11 (11)
2 (5)
0.5
Seroma
11 (11)
1 (2)
0.2
Hematoma
0
1 (2)
0.3
Wound infection
0
0
1
Umbilical hernia
0
0
1
Conversion
2 (2)
0
1
Recurrence
0
1 (2)
0.3
The data are given as the mean ± SD or number (%), unless otherwise specified SD standard deviation
conventional TEP group (p = 0.3). These seromas and hematomas were managed conservatively and had disappeared within 3 months after surgery. No other major complications, such as wound infections or umbilical hernias, were noted during the follow-up in either group. All conventional three-port TEP cases were completed without any conversion to open surgery. Two cases of SILS-TEP repair were converted to one conventional threeport TEP repair and one mesh-plug repair. The five cases with recurrent hernias in the SILS-TEP group were completed without conversion. One recurrence was found in the conventional TEP group during the follow-up period, but no recurrence was found in the SILS-TEP group. There were no significant differences between the two groups with regard to hernia recurrence (p = 0.3).
Discussion In this study, there were two important clinical observations. First, SILS-TEP repair seems to be safe and feasible, and offers good cosmetic results. There were also no significant differences between the two groups with regard to the total medical charges for the hospital stay. To many
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surgeons, the major concern about SILS-TEP repair is that the limitation of movement may lead to a longer operation, more postoperative complications and an increased recurrence rate. In the present study, there were no significant differences in terms of the length of the operation, blood loss, postoperative hospital stay, postoperative complications, conversion or the recurrence rate. These perioperative data were similar to those with open tension-free repair or laparoscopic repair that were reported previously [13]. In our institution, the introduction of SILS-TEP after 37 cases of conventional TEP was unproblematic, and there was almost no learning curve for SILS-TEP. We think that the learning curve for SILS-TEP is relatively easily overcome if the surgeon is experienced with conventional TEP, although Kim et al. [5] suggested that the learning curve for SILS-TEP is about 40 cases. Several studies have demonstrated that the conventional TEP repair technique is safe and feasible for complicated inguinal hernias, such as recurrent, scrotal or incarcerated hernias [14]. Garg et al. [15] reported that laparoscopic TEP repair is safe and feasible for recurrent hernias in a retrospective analysis of 52 recurrent hernias in a cohort of 937 patients. In the present SILS-TEP group, five recurrent hernias, including two recurrences after mesh-plug repair, were managed successfully without increasing the length of the operation or the perioperative complications. More experience is needed to demonstrate the safety and the feasibility of the SILS-TEP technique for treating complicated inguinal hernias. Second, SILS-TEP repair is comparable to conventional TEP repair in terms of the postoperative pain scores 3 months after surgery. Tsai et al. reported that the SILSTEP technique decreased the immediate postoperative pain (2-hour postoperative Visual Analogue Scale (VAS): 2.6 vs. 3.9 at rest, p = 0.02; 4.8 vs. 5.7, during cough, p = 0.09) and presumed that this may result from the reduced number of skin incisions made during SILS-TEP. Although we also hypothesized that the use of fewer ports and a shorter total skin incision length would reduce the postoperative pain, most patients complained of pain in the inguinal dissection area rather than at the post-insertion site, and the inguinal dissection area in the two groups was the same. The present trial showed no significant differences in the NRS scores between the two groups at 3 months after surgery. This result might have been affected by the choice of mesh or the use of mesh fixation, rather than the number of ports or the total length of the skin incision. The present study is associated with several possible limitations. First, the number of patients was small, and the patients were retrospectively selected. Therefore, some demographic and hernia characteristics were not comparable between the two groups. Second, the follow-up time
Surg Today
after SILS-TEP repair was significantly shorter than that after conventional TEP repair. Third, this study included cases managed during the learning curve. Therefore, some perioperative data may not have been comparable between the two groups. In conclusion, SILS-TEP repair seems to be safe and feasible, and offers good cosmetic results. There were no significant differences between the two groups with regard to the total medical charges for the hospital stay. The conventional TEP and SILS-TEP repair groups showed no significant difference in the postoperative pain scores 3 months after surgery. There were few complications and no recurrence during the short-term follow-up in the SILSTEP group. Further large-scale, randomized, controlled trials are needed to confirm our findings regarding the outcomes of SILS-TEP repair in comparison with conventional three-port TEP repair. Conflict of interest To declares a potential conflict of interest not directly related to the submitted work (a speaker’s fee). The other authors (MW, TM, MT, SU, MT, HA) each declare that they have no potential conflicts of interest.
References 1. Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989;157:188–93. 2. Gong K, Zhang N, Lu Y, Zhu B, Zhang Z, Du D, et al. Comparison of the open tension-free mesh-plug, transabdominal preperitoneal (TAPP), and totally extraperitoneal (TEP) laparoscopic techniques for primary unilateral inguinal hernia repair: a prospective randomized controlled trial. Surg Endosc. 2011;25: 234–9. 3. Filipovic-Cugura J, Kirac I, Kulis T, Jankovic J, Bekavac-Beslin M. Single-incision laparoscopic surgery (SILS) for totally extraperitoneal (TEP) inguinal hernia repair: first case. Surg Endosc. 2009;23:920–1. 4. Tai HC, Lin CD, Chung SD, Chueh SC, Tsai YC, Yang SS. A comparative study of standard versus laparoendoscopic singlesite surgery (LESS) totally extraperitoneal (TEP) inguinal hernia repair. Surg Endosc. 2011;25:2879–83.
5. Kim JH, Lee YS, Kim JJ, Park SM. Single port laparoscopic totally extraperitoneal hernioplasty: a comparative study of shortterm outcome with conventional laparoscopic totally extraperitoneal hernioplasty. World J Surg. 2013;37:746–51. 6. Tsai YC, Ho CH, Tai HC, Chung SD, Chueh SC. Laparoendoscopic single-site versus conventional laparoscopic total extraperitoneal hernia repair: a prospective randomized clinical trial. Surg Endosc. 2013;27:4684–92. 7. Wakasugi M, Akamatsu H, Tori M, Ueshima S, Omori T, Tei M, et al. Short-term outcome of single-incision laparoscopic totally extra-peritoneal inguinal hernia repair. Asian J Endosc Surg. 2013;6:143–6. 8. Wakasugi M, Akamatsu H, Yoshidome K, Tori M, Ueshima S, Omori T, et al. Totally extraperitoneal inguinal hernia repair in patients on antithrombotic therapy: a retrospective analysis. Surg Today. 2013;43:942–5. 9. Nakagawa M, Nagase T, Akatsu T, Imai S, Fujimura N, Asagoe T, et al. A randomized prospective trial comparing clinical outcomes 3 years after surgery by Marcy repair and Prolene Hernia System repair for adult indirect inguinal hernia. Surg Today. 2013;43:1109–15. 10. Hayashi Y, Miyata K, Yuasa N, Takeuchi E, Goto Y, Miyake H, et al. Short- and long-term outcomes of open inguinal hernia repair: comparison of the Prolene Hernia System and the Mesh Plug method. Surg Today. 2014. [Epub ahead of print]. 11. Kugel RD. Minimally invasive, nonlaparoscopic, preperitoneal, and sutureless, inguinal herniorrhaphy. Am J Surg. 1999;178: 298–302. 12. Kanda Y. Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant. 2013;48:452–8. 13. Choi YY, Han SW, Bae SH, Kim SY, Hur KY, Kang GH. Comparison of the outcomes between laparoscopic totally extraperitoneal repair and prolene hernia system for inguinal hernia; review of one surgeon’s experience. J Korean Surg Soc. 2012;82:40–4. 14. Bittner R, Arregui ME, Bisgaard T, Dudai M, Ferzli GS, Fitzgibbons RJ, et al. Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia [International Endohernia Society (IEHS)]. Surg Endosc. 2011;25:2773–843. 15. Garg P, Menon GR, Rajagopal M, Ismail M. Laparoscopic total extraperitoneal repair of recurrent inguinal hernias. Surg Endosc. 2010;24:450–4.
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ORIGINAL ARTICLE
Single-incision totally extraperitoneal inguinal hernia repair: our initial 100 cases and comparison with conventional three-port laparoscopic totally extraperitoneal inguinal hernia repair Masaki Wakasugi • Toru Masuzawa • Mitsuyoshi Tei • Takeshi Omori • Shigeyuki Ueshima Masayuki Tori • Hiroki Akamatsu
•
Received: 29 March 2014 / Accepted: 25 May 2014 Ó Springer Japan 2014
Abstract Purpose To compare the outcomes of single-incision laparoscopic surgery for totally extraperitoneal inguinal hernia repair (SILS-TEP) and conventional three-port totally extraperitoneal (TEP) repair. Methods We performed a retrospective analysis of 137 patients (SILS-TEP, 100; conventional TEP, 37) scheduled to undergo elective inguinal hernia from January 2011 to July 2013 at Osaka Police Hospital. Results There were no significant differences in the patient demographics. There were no significant differences in the length of the operation between the two groups (SILS-TEP group, 93 min vs. conventional TEP group, 92 min for unilateral hernias, p = 0.8; SILS-TEP group, 142 min vs. conventional TEP, 128 min for bilateral hernias, p = 0.4). The postoperative hospital stay, total medical charge for the hospital stay and the numerical rating scale before and 3 months after surgery were comparable in both groups. Two cases treated by SILS-TEP repair were converted to conventional three-port TEP repair (one case) and mesh-plug method (one case). The postoperative complications were comparable in both groups, and these were managed conservatively. One recurrence (2 %, 1/37) developed in the conventional TEP group, compared with 0 recurrences (0/100) in the SILS-TEP group. Conclusions SILS-TEP repair seems to be safe and feasible, with no significant differences in the total medical charges for the hospital stay or the postoperative pain score
3 months after surgery compared with conventional threeport TEP repair. Keywords Single-incision laparoscopic surgery (SILS) Totally extraperitoneal repair (TEP) Inguinal hernia
Introduction Inguinal hernia repair is the most frequently performed operation in general surgery. In addition to the tension-free repair [1] described by Lichtenstein in 1989, which significantly reduced the recurrence rates, the two most common laparoscopic techniques for the treatment of inguinal hernia, totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repairs, have also revolutionized the general surgical field [2]. The laparoscopic approach offers advantages in terms of less postoperative pain and a faster recovery, with a low incidence of recurrence. In the last few years, SILS has been introduced to further improve the surgical outcomes and cosmetic results. The first case of SILS-TEP repair was reported in 2009 [3], but relatively few descriptions and comparisons with the conventional three-port TEP have been published to date [4–6]. In this report, our results with SILS-TEP repair are presented, and the outcomes for SILS-TEP and conventional TEP repair are compared.
Materials and methods M. Wakasugi (&) T. Masuzawa M. Tei T. Omori S. Ueshima M. Tori H. Akamatsu Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Ten-nouji-ku, Osaka 543-0035, Japan e-mail: [email protected]
Patients We performed a retrospective analysis of adult patients scheduled for SILS-TEP or conventional three-port TEP
123
Surg Today Fig. 1 a The appearance of the Lap-Protector Mini in the incision. b The three ports secured to the EZ Access for the operation
inguinal hernia repair from January 2011 to November 2013 at Osaka Police Hospital. A total of 137 patients (SILS-TEP, 100; conventional TEP, 37) were evaluated. Until September 2011, we had performed the conventional three-port TEP repair method, but thereafter, we consecutively performed SILS-TEP repair [7, 8] for all patients undergoing laparoscopic inguinal hernia surgery. The patients with the following conditions were excluded from undergoing both procedures: patients with a previous history of radical prostatectomy; those with a recurrent hernia who had previously undergone preperitoneal hernia repair, such as the PHS repair [9, 10] or the Kugel repair [11] and patients who were not suitable for general anesthesia. Surgical technique Under general anesthesia with a transversus abdominis plane block, the patient was placed supine with both arms adducted. The patient was placed in the Trendelenburg position with the side contralateral to the hernia site tilted down. A single 25-mm subumbilical incision was made, followed by dissection of the subcutaneous tissue down to the rectus abdominis sheath. The anterior sheath was opened with an incision approximately 3 cm in length, and blunt dissection using a finger or gauze was performed between the muscle and the posterior sheath to create a preperitoneal space. Until April 2013, a single port access device (EZ Access; Hakko Co., Ltd., Nagano, Japan), through which three trocars (one 10-mm for a 10-mm flexible scope and two 5-mm) were inserted, and it was used to maintain the inflation of the preperitoneal space with carbon dioxide (CO2) gas, after a Lap-Protector Mini (Hakko Co., Ltd) was placed in the incision [9]. Thereafter, three 5-mm trocars for a 5-mm flexible scope were used (Fig. 1). In the SILS-TEP repair, the preperitoneal space was dissected gradually using conventional laparoscopic instruments without a dissection balloon. The conventional TEP repair was performed with three midline ports (one
123
Fig. 2 The postoperative scar 3 months after SILS-TEP repair for bilateral inguinal hernias
10-mm port for a 10-mm flexible scope and two 5-mm ports with a skin incision of 17 ± 8 mm 9 2 = approximately 33 mm in length total) after the dissection of the preperitoneal space under the midline from the subumbilical incision using the 10-mm flexible scope. A polypropylene mesh (3D Max LightÒ; C. R. BARD, Murray Hill, NJ, USA) was placed in this preperitoneal space, covering the inguinal floor, and fixation of the mesh was performed by the application of three absorbable tacks (AbsorbaTackTM; Covidien, Mansfield, MA, USA) at the pubic bone, at Cooper’s ligament and above the iliopubic tract. After completion of the operation, the preperitoneal space was deflated with care to avoid displacing the mesh. The anterior rectus sheath was closed with a 2-0 Vicryl suture, and the skin was closed with a 3-0 PDS suture (Fig. 2). The medical costs of the devices used for the two procedures were approximately 420 US dollars in the SILSTEP repair and 220 US dollars for the three-port TEP repair, respectively, with the approximately 200 US dollars higher for the SILS-TEP being due to the EZ Access and Lap-Protector Mini. The patients routinely took loxoprofen at 180 mg/day, rebamipide at 300 mg/day and cefcapene
Surg Today
pivoxil at 300 mg/day orally for 3 days from the first postoperative day.
Table 1 The characteristics of the patients and hernias Characteristics
SILS-TEP (n = 100)
Conventional TEP (n = 37)
p value
Age (years)
65 ± 12
61 ± 14
0.1
Male sex
87 (87)
34 (92)
0.6
BMI (kg/m2)
23 ± 3
24 ± 3
0.1
Median ASA (range)
2 (1–3)
2 (1–3)
0.8
Unilateral
88 (88)
32 (86)
0.8
Bilateral
12 (12)
5 (14)
0.8
36 (36)
11 (30)
0.5
Indirect hernia
75 (75)
31 (84)
0.4
Femoral hernia
3 (3)
0
0.6
Recurrent hernia
5 (5)
0
0.3
Scrotal hernia
1 (1)
1 (3)
0.4
Incarcerated hernia
0
0
1
Data collection The patients’ age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, site and type of hernia, length of operation, blood loss, postoperative hospital stay, medical charges for the hospital stay, follow-up duration, numerical rating scale (NRS) scores before and 3 months after surgery, postoperative complications, conversion to a different procedure and hernia recurrence were recorded. Pain was measured using an 11-point pain intensity NRS, where 0 = no pain and 10 = worst possible pain before and 3 months after surgery. Some patients were followed-up by phone calls, but for patients not available by phone, the last follow-up findings were used in the analysis. The results are expressed as the mean ± SD or numbers (percentages). Statistical analysis Student’s t test, Fisher’s exact probability test and the Mann–Whitney U test were used for the analysis of parametric and non-parametric data, as appropriate. The paired t test was used to analyze the NRS scores before and 3 months after surgery. Differences at p \ 0.05 were considered to be significant. All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for the R software program (The Foundation for Statistical Computing); more precisely, it is a modified version of R commander designed to add statistical functions frequently used in biostatistics [12].
Results The patients’ demographic data are shown in Table 1. There were no significant differences between the two groups with regard to the patient and the inguinal hernia characteristics. The recurrent hernias in the SILS-TEP group included two cases of recurrence after mesh-plug repair and three cases repaired without mesh. The perioperative data for the SILS and conventional TEP repair groups are summarized in Table 2. The mean length of the operation for a unilateral hernia in the SILS-TEP and conventional TEP groups was 93 ± 26 min (range 41–204 min) and 92 ± 29 min (range 55–166 min), respectively (p = 0.8). The mean length of the operation for bilateral hernias in the SILS-TEP and conventional TEP groups was 142 ± 28 min (range 102–182 min) and
Site of hernia
Type of hernia Direct hernia
The data are given as the mean ± SD or number (%), unless otherwise specified SD standard deviation, BMI body mass index, ASA American Society of Anesthesiologists
128 ± 36 min (range 88–173 min), respectively (p = 0.4). The blood loss was minimal in all cases. The mean postoperative hospital stay in the SILS-TEP and conventional TEP groups was 3.3 ± 1.0 days (range 1–7 days) and 3.4 ± 1.3 days (range 1–7 days), respectively (p = 0.9). The total medical charges for the hospital stay in the SILS-TEP and conventional TEP groups were 5800 ± 700 US dollars (range 4300–7700 dollars) and 5700 ± 700 US dollars (range 4700–7500 dollars) (p = 0.2). The mean follow-up period was 15 ± 7 months for the SILS-TEP cases and 29 ± 8 months for the conventional TEP cases, which was significantly shorter in the SILS-TEP group than in the conventional TEP group (p \ 0.05). The NRS score at 3 months after surgery was significantly lower than the NRS score before surgery in both groups (p \ 0.05), but there were no significant differences between the two groups before and 3 months after surgery. Postoperative complications were seen in 11 % (11/100) of the patients in the SILS-TEP group and 5 % (2/37) of the patients in the conventional TEP group (p = 0.5). A seroma was seen in 11 % (11/100) of the patients in the SILSTEP group and 2 % (1/37) of the patients in the conventional TEP group (p = 0.2). A hematoma in the umbilical wound was seen in 2 % (1/37) of the patients in the SILSTEP group and 0 % (0/100) of the patients in the
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Surg Today Table 2 The perioperative data for the SILS and conventional TEP repair groups Variable
SILS-TEP (n = 100)
Conventional TEP (n = 37)
p value
Length of operation 93 ± 26
92 ± 29
0.8
Bilateral (min) Blood loss
Unilateral (min)
142 ± 28 Minimal
128 ± 33 Minimal
0.6 –
Postoperative hospital stay, days
3.3 ± 1.0
3.4 ± 1.3
0.9
Medical charge for hospital stay, dollars
5800 ± 700
5700 ± 700
0.2
Follow-up duration, months
18 ± 7
32 ± 8
\0.05
Numerical rating scale Before surgery
2.8 ± 2.9
2.6 ± 3.0
0.8
3 months after surgery
0.4 ± 1.0
0.2 ± 0.9
0.3
Complications
11 (11)
2 (5)
0.5
Seroma
11 (11)
1 (2)
0.2
Hematoma
0
1 (2)
0.3
Wound infection
0
0
1
Umbilical hernia
0
0
1
Conversion
2 (2)
0
1
Recurrence
0
1 (2)
0.3
The data are given as the mean ± SD or number (%), unless otherwise specified SD standard deviation
conventional TEP group (p = 0.3). These seromas and hematomas were managed conservatively and had disappeared within 3 months after surgery. No other major complications, such as wound infections or umbilical hernias, were noted during the follow-up in either group. All conventional three-port TEP cases were completed without any conversion to open surgery. Two cases of SILS-TEP repair were converted to one conventional threeport TEP repair and one mesh-plug repair. The five cases with recurrent hernias in the SILS-TEP group were completed without conversion. One recurrence was found in the conventional TEP group during the follow-up period, but no recurrence was found in the SILS-TEP group. There were no significant differences between the two groups with regard to hernia recurrence (p = 0.3).
Discussion In this study, there were two important clinical observations. First, SILS-TEP repair seems to be safe and feasible, and offers good cosmetic results. There were also no significant differences between the two groups with regard to the total medical charges for the hospital stay. To many
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surgeons, the major concern about SILS-TEP repair is that the limitation of movement may lead to a longer operation, more postoperative complications and an increased recurrence rate. In the present study, there were no significant differences in terms of the length of the operation, blood loss, postoperative hospital stay, postoperative complications, conversion or the recurrence rate. These perioperative data were similar to those with open tension-free repair or laparoscopic repair that were reported previously [13]. In our institution, the introduction of SILS-TEP after 37 cases of conventional TEP was unproblematic, and there was almost no learning curve for SILS-TEP. We think that the learning curve for SILS-TEP is relatively easily overcome if the surgeon is experienced with conventional TEP, although Kim et al. [5] suggested that the learning curve for SILS-TEP is about 40 cases. Several studies have demonstrated that the conventional TEP repair technique is safe and feasible for complicated inguinal hernias, such as recurrent, scrotal or incarcerated hernias [14]. Garg et al. [15] reported that laparoscopic TEP repair is safe and feasible for recurrent hernias in a retrospective analysis of 52 recurrent hernias in a cohort of 937 patients. In the present SILS-TEP group, five recurrent hernias, including two recurrences after mesh-plug repair, were managed successfully without increasing the length of the operation or the perioperative complications. More experience is needed to demonstrate the safety and the feasibility of the SILS-TEP technique for treating complicated inguinal hernias. Second, SILS-TEP repair is comparable to conventional TEP repair in terms of the postoperative pain scores 3 months after surgery. Tsai et al. reported that the SILSTEP technique decreased the immediate postoperative pain (2-hour postoperative Visual Analogue Scale (VAS): 2.6 vs. 3.9 at rest, p = 0.02; 4.8 vs. 5.7, during cough, p = 0.09) and presumed that this may result from the reduced number of skin incisions made during SILS-TEP. Although we also hypothesized that the use of fewer ports and a shorter total skin incision length would reduce the postoperative pain, most patients complained of pain in the inguinal dissection area rather than at the post-insertion site, and the inguinal dissection area in the two groups was the same. The present trial showed no significant differences in the NRS scores between the two groups at 3 months after surgery. This result might have been affected by the choice of mesh or the use of mesh fixation, rather than the number of ports or the total length of the skin incision. The present study is associated with several possible limitations. First, the number of patients was small, and the patients were retrospectively selected. Therefore, some demographic and hernia characteristics were not comparable between the two groups. Second, the follow-up time
Surg Today
after SILS-TEP repair was significantly shorter than that after conventional TEP repair. Third, this study included cases managed during the learning curve. Therefore, some perioperative data may not have been comparable between the two groups. In conclusion, SILS-TEP repair seems to be safe and feasible, and offers good cosmetic results. There were no significant differences between the two groups with regard to the total medical charges for the hospital stay. The conventional TEP and SILS-TEP repair groups showed no significant difference in the postoperative pain scores 3 months after surgery. There were few complications and no recurrence during the short-term follow-up in the SILSTEP group. Further large-scale, randomized, controlled trials are needed to confirm our findings regarding the outcomes of SILS-TEP repair in comparison with conventional three-port TEP repair. Conflict of interest To declares a potential conflict of interest not directly related to the submitted work (a speaker’s fee). The other authors (MW, TM, MT, SU, MT, HA) each declare that they have no potential conflicts of interest.
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