Feasibility of Single-Incision Laparoscopic Percutaneous Extraperitoneal Closure for Inguinal Hernia by Inexperienced Pediatric Surgeons: Single-Incision Versus Multi-Incision Randomized Trial for 2 Years

Abstract

Purpose:

This study evaluated the stability and risk of single-incision laparoscopic percutaneous extraperitoneal closure (SILPEC) for pediatric inguinal hernia performed by inexperienced pediatric surgeons versus conventional LPEC procedure.

Methods:

Between 2011 and 2012, a randomized prospective study was performed comparing SILPEC (n = 37, 16 uni- and 21 bilateral patent processus vaginalis [PPV]) to LPEC (n = 72, 39 uni- and 33 bilateral PPV). The procedures were performed in girls with inguinal hernia by inexperienced pediatric surgeons with the assistance of an expert pediatric surgeon. In SILPEC, a laparoscope was placed through a transumbilical incision. A 2-mm trocar for the grasper was inserted through the same incision and introduced into the extraperitoneal cavity. The tip of the trocar was inserted in the abdominal cavity distant from the umbilical incision by the expert surgeon to avoid any complications caused by the in-line view. Using a special needle, the hernial sac was closed extraperitoneally by the inexperienced surgeon. A statistical survey of the mean age at operation, mean operative time, intra- and postoperative complications, and recurrence in the SILPEC and LPEC groups was performed.

Results:

There were no significant differences in the mean age or operative time. There were fewer total number of postoperative complications in the SILPEC group compared with the LPEC group (P = .0707). No intraoperative complications or recurrence occurred.

Conclusions:

Considering the risks and need to improve endoscopic surgical skills with useful instruments specialized for SILPEC, inexperienced surgeons can successfully perform SILPEC safely under expert pediatric surgeons.

Introduction

Laparoscopic percutaneous extraperitoneal closure (LPEC) for pediatric inguinal hernia is one of the most simple and reliable methods used in Japan. The method was introduced by Takehara et al. in 1995,¹ and has become the most applied laparoscopic approach in Japan because of its simplicity and effectiveness.² In LPEC, the orifice of the hernial sac is closed extraperitoneally with circuit suturing around the internal inguinal ring using a special needle (LPEC needle).¹ Recently, the single-incision approach for pediatric inguinal hernia was developed—single-incision laparoscopic percutaneous extraperitoneal closure (SILPEC)—in order to improve the safety and reduce the invasiveness of the conventional LPEC procedure. The biggest benefit for patients undergoing SILPEC is cosmetic appearance, as the operative scar is only that of an intra-umbilical incision and needle puncture. Some authors have reported on the safety and feasibility of SILPEC,^3,4 and LPEC/SILPEC procedures are performed by inexperienced pediatric surgeons with the assistance of an attending expert surgeon. Although LPEC/SILPEC is a simple technique, the operators require training in how to use the special equipment as well as basic endoscopic surgical skills. A combination of needle and forceps manipulation is a specific technique for these procedures, which is different from bi-hand forceps manipulation used in conventional endoscopic surgery.

At the authors' institution, the LPEC procedure was introduced in January 2007, and was further introduced for inexperienced pediatric surgeons in August 2007 in order to train these physicians in endoscopic surgical procedures. Since January 2011, the SILPEC procedure has been attempted as a reduced-port surgical approach.

There have been many reports about the use of SILPEC and LPEC procedures by experienced pediatric surgeons. However, there are no reports about the SILPEC procedure performed by inexperienced pediatric surgeons, such as residents. This study aimed to verify the feasibility and risk of the SILPEC procedure performed by inexperienced pediatric surgeons in comparison to the LPEC procedure.

Materials and Methods

Study design

Between January 2011 and December 2012, a randomized prospective study was conducted among patients undergoing SILPEC (n = 37 patients, 16 uni- and 21 bilateral patent processus vaginalis [PPV]) and LPEC (n = 72, 39 uni- and 33 bilateral PPV) procedures at the authors' institution, according to the Ethical Guidelines for Clinical Research published by the Ministry of Health, Labour, and Welfare of Japan on July 30, 2003 (revised in 2008), and in compliance with the Helsinki Declaration of 1964 (revised in 2008). Both procedures were described to each patient and their parents during the informed consent process before surgery, and the parents chose the procedure for hernia closure.

Surgical procedures

Fifteen inexperienced pediatric surgeons, who had not done the SILPEC or LPEC procedure before or who were within a year of their initial 2-year clinical training after graduation from medical school, performed inguinal hernia repairs as operators with the assistance of an expert pediatric surgeon, with experience of endoscopic surgery (e.g., >30 SIPEC or LPEC or >10 laparoscopic Nissen fundoplication procedures). Laparoscopic repair of pediatric inguinal hernias was performed in girls only, whereas the groin incision approach was employed in boys in order to prevent tying the vas and gonadal vessels in the LPEC procedure.

After general anesthesia, the patients were placed in the supine position. The following procedures were performed using modified methods of the original method developed by Takehara et al.¹ A laparoscope (30°, 3 mm) was placed through a transumbilical incision by the inexperienced pediatric surgeon with the aid of the expert surgeon for SILPEC and LPEC. For SILPEC, a 2-mm trocar for the 2-mm grasper was inserted through the same transumbilical incision and introduced into the extraperitoneal space, and the tip of the trocar was inserted in the abdominal cavity distant from the umbilical incision by the expert surgeon. The expert surgeon inserted the 2-mm trocar in order to prevent erroneous puncture of the intestines, inferior epigastric artery, or lower lateral abdomen because the distance between the laparoscope and the site of the 2-mm trocar was so close that the insertion of the trocar was performed almost under in-line view. On the other hand, for LPEC, the 2-mm trocar for the 2-mm grasper was inserted in the abdominal wall between the umbilicus and pubic tubercle by the inexperienced pediatric surgeon. Using a 19-gauge special needle (with a wire loop to hold the material at the tip; Lapaherclosure^™; Hakko, Nagano, Japan) with non-absorbable thread (2-0 Surgilon, Covidien, Mansfield, MA), the hernial sac was closed extraperitoneally by the inexperienced surgeon. The first half of the circuit suturing was begun extraperitoneally from the anterior to the posterior edge of half of the internal inguinal ring using Lapaherclosure with non-absorbable thread. After half of the circuit suturing was completed, the thread was removed from the Lapaherclosure. The circuit suturing of the opposite half of the rim of the internal ring was placed extraperitoneally using the same technique, and the thread was held by the wire loop inside the Lapaherclosure. The Lapaherclosure was then removed from the abdomen, together with the thread. The circuit suturing was tied extraperitoneally, and the internal inguinal ring was completely closed. When an asymptomatic contralateral large PPV was observed, bilateral closure was performed according to the same procedure.

The umbilical wound was closed by suturing the peritoneum and fascia by the inexperienced pediatric surgeon. The 2-mm wounds and the needle wound were closed by surgical tapes by the inexperienced pediatric surgeon.

All patients were scheduled to be admitted to the hospital 1 day before the operation, and discharged from the hospital 1 day after the operation, except in cases of severe complications such as hemorrhage or pneumonia. After being discharged from the hospital, all patients were scheduled for follow-up visits at 1 week, 1 month, 3 months, 6 months, and 1 year.

Analysis

The mean age at operation, mean operative time, erroneous puncture of the intestine, inferior epigastric artery, or lower lateral abdomen, surgical-site infection (SSI) or umbilical proptosis as intra- or postoperative complications, respectively, and recurrence were surveyed in the SILPEC and LPEC groups. In the same way, subgroups of uni- and bilateral PPV were surveyed in each major group. For the statistical analysis, the unpaired Student's t-test and Mann–Whitney U-test were used. A P value of <.05 was considered to be significant.

Results

Fifteen inexperienced pediatric surgeons participated in this study. Tables 1 and 2 show the results. Overall, there were no significant differences in the mean age at the time of the operation (SILPEC versus LPEC: 4.55 ± 2.74 versus 4.19 ± 2.68 years, P = .509) or the mean operative time (SILPEC versus LPEC: 45.16 ± 13.37 versus 50.97 ± 19.23 minutes, P = .103). During the follow-up period (1 week–1 year after surgery), the total number of postoperative complications was lower in the SILPEC group than it was in the LPEC group (SILPEC: 1 [2.7%]; LPEC: 8 [11.1%], P = .133). There were no intraoperative complications, such as erroneous puncture of the intestine, inferior epigastric artery, or lower lateral abdomen, or episodes of recurrence during the follow-up period in either the SILPEC or the LPEC group (Table 1). The same results were obtained for both the uni- and bilateral subgroups (P > .05 respectively; Table 2). No apparent SSI occurred during the follow-up period, but superficial prolonged wound healing occurred within a week after surgery (SILPEC versus LPEC—total: 1 [2.7%] versus 8 [8.3%], P = .258; unilateral: 1 [6.3%] versus 5 [12.8%], P = .487; bilateral: 0 versus 1 [3.0%], P = .798), all of which were superficial and were cured conservatively within a month. Postoperative umbilical proptosis occurred within 3 months after surgery (SILPEC versus LPEC—total: 0 versus 2 [2.8%], P = 1.0185; unilateral: 0 versus 1 [2.6%], P = .6405; bilateral: 0 versus 1 [3.0%], P = .798), all of which became reduced in size and improved by the final follow-up period.

Table 1.

Comparison Between the SILPEC and LPEC Groups

	Total
	SILPEC (n = 37)	LPEC (n = 72)	P value
Age (years)	4.55 ± 2.74	4.19 ± 2.68	.5091
Operating time (minutes)	45.16 ± 3.37	50.97 ± 19.23	.1033
Postoperative complications
Total	1 (2.7%)	8 (11.1%)	.1327
Superficial prolonged wound healing	1 (2.7%)	6 (8.3%)	.2584
Umbilical proptosis	0	2 (8.3%)	1.0185
Recurrence	0	0

SILPEC, single-incision laparoscopic percutaneous extraperitoneal closure; LPEC, laparoscopic percutaneous extraperitoneal closure.

Table 2.

Comparison Between the Uni- and Bilateral PPV Subgroups of the SILPEC and LPEC Groups

	Unilateral PPV			Bilateral PPV
	SILPEC (n = 16)	LPEC (n = 39)	P value	SILPEC (n = 21)	LPEC (n = 33)	P value
Age (years)	5.28 ± 2.41	4.35 ± 2.84	.2568	4.00 ± 2.91	4.01 ± 2.51	.9965
Operating time (minutes)	41.19 ± 12.80	46.31 ± 18.31	.3130	48.19 ± 13.29	56.48 ± 19.10	.0881
Postoperative complications
Total	1 (6.3%)	6 (15.4%)	.3603	0	2 (6.1%)	.2586
Superficial prolonged wound healing	1 (6.3%)	5 (12.8%)	.4869	0	1 (3.0%)	.7977
Umbilical proptosis	0	1 (2.6%)	.6405	0	1 (3.0%)	.7977

PPV, patent processus vaginalis.

Discussion

The first report of laparoscopic herniorrhaphy in the pediatric population was in 1998, with successful management.⁵ Since then, several procedures have been developed, and the safety and feasibility of laparoscopic procedures have been reported.^6–8

Among the several procedures or laparoscopic herniorrhaphy, the most popular procedure in Japan is LPEC. This procedure was reported by Takehara et al. in 1995¹ with a simple method. Other procedures for treating pediatric inguinal hernias have been reported^5,9,10 with three ports required (one for the laparoscope, one for the grasper, and one for the needle holder), whereas LPEC requires just two ports (one for the laparoscopy and one for the grasper). Based on its simplicity and reduced complications, this procedure was introduced for use by young pediatric surgeons as for the first steps in endoscopic surgical techniques as well as appendectomy in Japan. Although LPEC is a simple procedure, it requires specific techniques, such handling the special needle. In addition, in SILPEC, insertion of the second trocar must be done with almost a blind view. Therefore, it is difficult for inexperienced pediatric surgeons, and there is possibility of erroneous puncture of the intestines or inferior epigastric artery.

SILPEC for pediatric inguinal hernia was first reported in 2010 and compared to the conventional LPEC procedure.³ In that report, SILPEC proved to be a successful operative procedure, similar to LPEC, and produced excellent cosmetic results. Another report suggested that the advantages of SILPEC include not only a cosmetic benefit, but also a lower risk of injury to the spermatic duct and vessels.⁴

At the authors' institution, the LPEC procedure was introduced in August 2007 for inexperienced pediatric surgeons to train them in endoscopic surgical procedures as laparoscopic operators. The SILPEC procedure has been attempted as a reduced-port surgical approach since January 2011. Against this background, this study aimed to verify the stability and risk of SILPEC performed by inexperienced pediatric surgeons compared to the LPEC procedure.

This study has some limitations, such as the number of the patients. There was a difference in the number of patients in each group (SILPEC: n = 37; LPEC: n = 72). This may have resulted in no significant difference in the prevalence of SSI or postoperative umbilical proptosis.

There were also no significant differences in the mean operative time (SILPEC versus LPEC: 45.16 ± 13.37 versus 50.97 ± 19.23 minutes, P = .103), which was longer than that observed in previous reports.^{3, 4} This is because all operators were inexperienced pediatric surgeons. On the other hand, during the follow-up period (1 week–1 year after surgery), there was no recurrence in either the SILPEC or the LPEC group.

There were postoperative complications, including prolonged wound healing. The total number of postoperative complications was lower in the SILPEC group than it was in the LPEC group (SILPEC: 1; LPEC: 8; P = .133). Specifically, the number of prolonged wound healing was lower in the SILPEC group than it was in the LPEC group. In the LPEC group, there were two trocars compared with one in the SILPEC group. There is therefore a possibility that the number of wounds increased according to the number of trocars. In addition, there were no major complications, such as intraoperative puncture of the intestines or inferior epigastric artery. In the SILPEC group, a 2-mm trocar was inserted through the same transumbilical incision and introduced into the extraperitoneal space. The tip of the trocar was inserted into the abdominal cavity distant from the umbilical incision by the expert surgeon under an in-line view. This maneuver is performed almost blind. Hence, the risk increases for inexperienced pediatric surgeons.

In conclusion, the findings of this randomized study show that SILPEC achieves equivalent outcomes to LPEC when performed by an inexperienced pediatric surgeon with the assistance of an expert surgeon. However, in the SILPEC group, the trocars for the grasper had to be inserted in almost a blind manner, which is risky for inexperienced doctors, thus increasing the possibility of erroneous puncture of the intestines or inferior epigastric artery. Considering this risk and the efficacy in improving endoscopic surgical skills using instruments specialized for SILPEC, even inexperienced surgeons can perform the SILPEC procedure safely, with reduced invasiveness compared with conventional LPEC.

Footnotes

Acknowledgment

We thank Mr. Brian Quinn for his comments and help with the manuscript.

Disclosure Statement

No competing financial interest exists.

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