Does the “Endoscopic Surgical Skill Qualification System” Reduce Serious Intraoperative Complications in the Field of Pediatric Surgery?

Abstract

Background:

The Japanese endoscopic surgical skill qualification system (ESSQS) in pediatric surgery was started 10 years ago to encourage safe and appropriate pediatric minimally invasive procedures and avoid severe complications. The present study investigated the impact of the ESSQS on the incidence of serious complications in the field of pediatric endoscopic surgery.

Materials and Methods:

We sent a questionnaire to institutes belonging to the Japanese Pediatric Endoscopic Surgery Group. Institutes were divided into two groups: institutes with (Group A) or without (Group B) ESSQS-qualified pediatric surgeons at any point in the last 10 years. Intraoperative complications (grade 3 and 4 under the Classification of Intraoperative Complications [CLASSIC] classification), postoperative complications (grade ≥IIIb under the Clavien/Dindo classification), and the number and rate of endoscopic procedures and complications of advanced and common procedures were compared between the two groups. This study is an exempt survey since no patient identifier has been collected.

Results:

We collected answers from 46 of 102 institutes (response rate: 45%) (Group A: 18 institutes, Group B: 28 institutes). Intra/postoperative complications were significantly more frequent in Group A than in Group B (P = .02 and P < .001, respectively). Endoscopic operations accounted for a larger proportion of advanced and common surgeries in Group A than in Group B, and the rate of postoperative complications of advanced procedures was significantly higher in Group A than in Group B (P = .012).

Conclusion:

While endoscopic surgery was performed more frequently in Group A than in Group B, the incidence of intra/postoperative serious complications was significantly higher in Group A. The current Japanese ESSQS was unable to markedly reduce the rate of serious complications.

Introduction

The indications and targets of endoscopic surgery are rapidly expanding, even in the field of pediatric surgery. Characteristic of Japan, pediatric surgery is performed in many facilities, and the number of so-called advanced surgeries performed in each facility is limited.

In 2008, following its introduction in other fields (e.g., gastrointestinal surgery, urology, and gynecology), the endoscopic surgical skill qualification system (ESSQS) was introduced in pediatric surgery through the joint efforts of the Japanese Society of Pediatric Endoscopic Surgeons and the Japan Society for Endoscopic Surgery. The standard requirement for the ESSQS is the ability of the applicant to complete common types of endoscopic surgery, and the main goal of this system is to reduce the rate of complications of endoscopic surgery by certifying applicants as having sufficient skills to perform endoscopic surgery safely.¹

The details of the ESSQS in pediatric surgery have been described previously.² In brief, the minimum requirements for applicants are as follows: completion of at least 7 years of surgical training (general and pediatric); experience with more than 50 pediatric minimally invasive surgeries, including 20 advanced surgeries; being certified by the Board of the Japanese Society of Pediatric Surgeons (JSPS); and having recommendations from at least 2 supervisors with knowledge of the applicant's endoscopic surgical skills. Applicants are required to submit an unedited video recording of them performing laparoscopic fundoplication or splenectomy. Two referees assign a score out of 100 points according to the checklist, and applicants with scores of ≥75 points are subsequently certified.

We conducted a questionnaire survey to determine the current status of endoscopic surgery over the last 10 years since the introduction of the ESSQS to the field of pediatric surgery.

Materials and Methods

Survey procedure

The questionnaires were sent to all 102 institutions covered by the Japanese Society of Pediatric Endoscopic Surgeons. The questionnaire inquired about the following items: institutional characteristics, type of facility (university hospital, children's hospital, general hospital, and others), total number of pediatric surgeons, and total number of ESSQS-qualified pediatric surgeons.

Surgical statistics (in patients <15 years old, January 2009 to December 2018) were also collected, as follows: number of total and endoscopic surgeries and intra/postoperative complications with or without the involvement of ESSQS-qualified pediatric surgeons. Regarding the number of operations and intra/postoperative complications, the following operations were separately tabulated: advanced procedures (lung resection, neonatal congenital diaphragmatic hernia repair, esophageal atresia repair, choledochal cyst operation, fundoplication, and splenectomy), and common procedures (appendectomy, inguinal herniorrhaphy, and pyloromyotomy). Only for fundoplication, patients over 16 years of age were also included, according to the rules of the ESSQS. Replies were requested to be made anonymously.

Definition of intraoperative and postoperative complications

In this study, intraoperative complications were defined as those of Grade 3 and 4 under the Classification of Intraoperative Complications (CLASSIC),³ which covers any deviation from the ideal intraoperative course leading to a life-threatening condition and/or permanent disability (Grade 3) or death (Grade 4).

Postoperative complications were defined as those of Grade IIIb (requiring surgical, endoscopic, or radiological intervention under general anesthesia) or above under the Clavien/Dindo classification of surgical complications.⁴

Groups

Institutes were divided into two groups: Group A, institutes with an ESSQS-qualified pediatric surgeon at any point in the last 10 years; and Group B, institutes without an ESSQS-qualified pediatric surgeon in the last 10 years.

Outcomes

The primary outcomes were serious intraoperative and postoperative complications described above. Secondary outcomes were the number and percentage of endoscopic surgeries for each procedure (lung resection, neonatal congenital diaphragmatic hernia repair, esophageal atresia repair, choledochal cyst operation, fundoplication, splenectomy, appendectomy, inguinal herniorrhaphy, and pyloromyotomy). We also evaluated the adoption rate for each procedure. These outcomes were compared between the two groups. The adoption rate of endoscopic surgery was calculated as follows: first, institutions with no cases of specific diseases during the period were excluded; institutions with at least one endoscopic operation were considered to have adopted the approach.

Statistical analyses

Continuous data are expressed as the mean ± standard deviation values. The statistical significance was calculated using Student's t-test and chi-squared test. All statistical analyses were performed with the JMP software program (version 10; SAS Institute, Inc., Cary, NC). A value of P < .05 was considered to be statistically significant.

Results

We sent questionnaires to 102 institutions and received responses from 46 (45.1%). Of these, 28 were university hospitals, 9 children's hospitals, and 9 general hospitals. To date, 41 pediatric surgeons have passed the skill qualification evaluation, with an average pass rate of ∼30% (data not shown). As a result, 18 institutes were classified into Group A, and 28 institutes were classified into Group B.

Although there was no significant difference in the hospital type, the total number of pediatric surgeons, or total number of all operations, the number of endoscopic surgeries (laparoscopic and thoracoscopic) was significantly larger in Group A than in Group B (P = .024) (Table 1).

Table 1.

Background Characteristics of Each Group

	Group A (n = 18)	Group B (n = 28)	P
Hospital classification			.889
University	11	17
Children's	4	5
General	3	6
No. of total pediatric surgeons	6.5 ± 3.6	5.2 ± 3.1	.204
No. of total operation	3793 ± 2597	2960 ± 1681	.203
No. of endoscopic surgery	1050 ± 854	591 ± 538	.024

The rates of intraoperative and postoperative complications in endoscopic surgery were compared between the groups (Table 2). The total number of endoscopic surgeries was 18,901 in Group A and 16,813 in Group B. Regarding intraoperative complications, all complication reports were Grade 3. Intraoperative complications were significantly more frequent in Group A (13 cases, 0.07%) than in Group B (3 cases, 0.02%) (P = .023). There were 78 postoperative complications in Group A (0.41%) and 14 in Group B (0.08%). Neither group had any Grade V postoperative complication. In Group A, 6 cases were reported as Grade IV postoperative complications. The rate of postoperative complications was significantly higher in Group A than in Group B (P < .001) (Table 2).

Table 2.

Intraoperative and Postoperative Complications (Overall)

	Group A (n = 18,901)	Group B (n = 16,813)	P
Intraoperative complications	0.07% (13)	0.02% (3)	.023
Grade 3	13	3
Grade 4	0	0
Postoperative complications	0.41% (78)	0.08% (14)	<.001
Grade IIIb	72	14
Grade IV	6	0
Grade V	0	0

Tables 3 and 4 show the total operations, endoscopic operation rate, and the rate of intra/postoperative complications in advanced and common procedures. Regarding advanced procedures, the rates of endoscopic operations and postoperative complications were significantly higher in Group A than in Group B (Table 3). However, even though the endoscopic operation rate was higher in Group A, the complication rates were not significantly different between the two groups in common procedures (Table 4).

Table 3.

Intraoperative and Postoperative Complications (Advanced Procedures)

	Group A	Group B	P
Total operations	3808	3050
Endoscopic operation rate	57.40%	38.20%	<.001
Intraoperative complications, rate (cases)	0.54% (12)	0.26% (3)	.228
Postoperative complications, rate (cases)	1.74% (38)	0.69% (8)	.012

Table 4.

Intraoperative and Postoperative Complications (Common Procedures)

	Group A	Group B	P
Total operations	23,982	32,061
Endoscopic operation rate	46.80%	40.00%	<.001
Intraoperative complications, rate (cases)	0% (0)	0% (0)	.228
Postoperative complications, rate (cases)	0.16% (18)	0.10% (13)	.203

Although significant differences in the adoption rate were confirmed in only cases of esophageal atresia and choledochal cyst, the adoption rates were higher in Group A than in Group B for all other procedures (Table 5).

Table 5.

Adoption Rate of Each Endoscopic Procedures in Both Groups

	Group A (%)	Group B (%)	P
Lung resection	94.10	83.30	.29
Esopageal atresia repair	41.10	12.00	.03
Neonatal CDH repair	58.80	30.40	.07
Fundoplication	100	100	—
Choledochal cyst operation	66.60	28.50	.01
Splenectomy	94.10	91.60	.76
Inguinal herniorrhaphy	94.40	92.80	.83
Appendectomy	100	96.40	.41
Pyloromyotomy	27.70	10.70	.13

CDH, congenital diaphragmatic hernia.

Discussion

Endoscopic surgery is spreading rapidly because it is associated with small incisions, reduced postoperative pain, reduced postoperative adhesion, and good vision, even in a deep surgical field. In 2008, the Japanese ESSQS was introduced in pediatric surgery through the joint efforts of the Japanese Society of Pediatric Endoscopic Surgeons and the Japan Society for Endoscopic Surgery. This is the first extensive review of the ESSQS of pediatric surgery in Japan over the past decade. The main goal of this system is to reduce the number of complications associated with endoscopic surgery, therefore, we conducted the present study to clarify whether or not the frequency of severe intraoperative and postoperative complications is associated with the presence of ESSQS-qualified pediatric surgeon.

There were no marked differences in the size of the departments and total number of operations, but the number of endoscopic operations was higher in Group A than in Group B, suggesting that endoscopic surgery was being aggressively performed. Contrary to expectations, intraoperative and postoperative complications were both more frequent in Group A than in Group B. Even when limiting our analysis to advanced surgeries, the rates of postoperative complications were significantly higher in Group A than in Group B. These findings indicate that advanced and common endoscopic surgeries can be performed safely despite the absence of ESSQS-qualified pediatric surgeons.

One reason for the unexpected results may be due to the fact that “advanced” endoscopic operations tended to be aggressively performed at the institutes of Group A, as expected from the results of adoption rate for advanced procedures. In addition, training in endoscopic surgeries may have been performed more generally in Group A than in Group B. In Group A, ESSQS-qualified pediatric surgeons participated in most advanced endoscopic operations. Therefore, statistical processing of subgroup analyses in Group A could not be performed. In addition, there was no marked difference in the incidence, even for just surgeries involving ESSQS-qualified pediatric surgeons (data not shown).

There have been several reports on Japanese ESSQS, including other fields.^1,2,5–8 Kimura et al. reported that the incidence of complications was significantly lower in patients treated by successful applicants than by failed applicants in gastrointestinal surgery.⁵ However, there were limitations in that the definition of complications was imprecise, and the frequency of complications was self-reported at the time of application and may not have been the results after qualification. Habuchi et al. reported the results of an extensive follow-up of ESSQS-qualified urologists.⁶ Although they reported excellent surgical results (intraoperative and postoperative complications, mortality, conversion rate, and blood loss), it was not a census or comparative study.

This is the first report on the evaluation of Japanese ESSQS of pediatric surgery. These results revealed that the ESSQS, which has a primary goal of reducing complications of endoscopic surgery, was unable to reduce the rates of serious intraoperative and postoperative complications. This lack of promising results in the field of pediatric surgery, in contrast to the findings in other fields, may be due to several reasons. First, ESSQS-qualified pediatric surgeons were a small group, accounting for only 10% of the pediatric surgeons certificated by the JSPS. This may have caused a significant bias in the results. Second, the procedures subjected to video judgment (limited to fundoplication and splenectomy) might not be included among the various techniques required for advanced surgery. Finally, the video judgments were often inconsistent among referees (data not shown). This interrater agreement was also not high (0.21–0.59) in other regions.⁸ The current video judgment system may thus not be objective. High interrater agreement is essential for such an examination method.

The limitations of this study are that the complications were limited to serious ones, it did not allow for an assessment of the quality (e.g., operation time and blood loss), it did not consider patients' risk, and it had a low response rate. More detailed surgical quality studies will be required to evaluate the effect of the ESSQS on the outcomes of pediatric surgery.

In conclusion, according to our data, the current pediatric ESSQS has failed to reduce the incidence of serious complications related to pediatric endoscopic surgery. It may be necessary to improve the system by regularly examining the intraoperative and postoperative results in the future.

Footnotes

Acknowledgment

The authors thank the members of the Japanese Pediatric Endoscopic Surgery Group for their cooperation with this survey.

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

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