Development and Validation of a Laparoscopy Simulation Model of Pyeloplasty for Pediatric Patients

Abstract

Introduction:

Given the extensive training required for laparoscopic pyeloplasty and the difficulties achieving this training, there is a need to recreate the activity in a controlled environment, but high-fidelity models are unavailable or expensive. Our objective was to develop a model of pyeloureteral junction stenosis, resembling the anatomical details and consistency of natural tissue, for a replicable, cheaper, and realistic simulation model of laparoscopic pyeloplasty in children.

Materials and Methods:

A three-dimensional, printed synthetic model was created from magnetic resonance urography. The model comprises a plastic kidney as the reusable structure and a silicone renal pelvis and ureter as the interchangeable structure. We evaluated realism and performance with surgeons and residents at different levels of training, comparing operative time and complications of the procedure.

Results:

Twenty-four participants were recruited; 41.7% had previous experience in laparoscopic pyeloplasty, with 5.5 years of experience in laparoscopic surgery (interquartile range [IQR] 2–7.75). There were no cases of stenosis, but leaks accounted for 41.7%. The procedure lasted 72 minutes (IQR 55–90), with significant differences according to the level of training (85 minutes for residents, 68 minutes for pediatric surgeons and urologists, and 40 minutes for laparoscopic surgeons; P: .011) and years of previous experience in laparoscopic surgery (P: .003).

Conclusions:

A high-fidelity, replicable, and low-cost pyeloureteral stenosis model was developed to simulate laparoscopic pyeloplasty in pediatric patients.

Introduction

Pyeloureteral stenosis is a common congenital condition with an incidence of 1/750–1500 live births, causing 5%–20% of prenatal hydronephrosis.^1–4 It is characterized by partial or total obstruction of urinary flow between the renal pelvis and the ureter, which can gradually deteriorate renal function, requiring timely surgical intervention.¹ Surgical intervention is suggested when there is deterioration of renal function (greater than 10%), decrease in relative function to 40% or less, T½ > 20 minutes in 99mTc-DTPA and 99mTc-MAG3 renal scintigraphy, and progressive or massive hydronephrosis (pelvis >50 mm).²

The treatment of choice is dismembered pyeloplasty, with similar outcomes for laparoscopic and open approaches. Although dismembered pyeloplasty requires a longer operative time, it is a minimally invasive surgery with image magnification; shorter hospitalization; less surgical trauma, pain, and bleeding; and fewer infection rates, but similar complication rates in children.^3–5 The suture technique was applied according to the surgeon's preference with no influence on outcomes.^3,6

Dismembered pyeloplasty is a complex procedure requiring advanced training, coordination, precision, and skills in intracorporeal suturing and knot tying with a learning curve of 15–30 procedures.^1,7 Given the complexity of the procedure, advances in technology, and lower exposure, there are serious ethical issues that need to be considered when performing it for the first time in a patient.

In most surgical programs in our country, the skills in minimally invasive surgery are developed after direct exposure to patients and a certain number of procedures have been performed as a camera assistant, then first assistant, and finally, as the lead surgeon, always under the supervision of a senior surgeon.⁸ This traditional model is limited to the teacher's experience and ability to teach, as well as the fear of frustration and patient complications.⁹

Since 1985, simulation has become a fundamental tool for development and improvement of skills in minimally invasive surgery, leading to safer and more efficient practices.^10,11 Simulators are classified according to their precision (low or high fidelity), complexity (low or high), and purpose (complete procedure or partial tasks).¹¹ The simulation model seeks to resemble reality and is accessible, low cost, and reproducible, helping develop specific skills to perform the surgical procedure—in this case, laparoscopic pyeloplasty, a treatment for children with pyeloureteral stenosis.

Despite the growing number of simulators in pediatric surgery,¹² the experience in our setting is limited. Basic skills in laparoscopic surgery are taught in residency and fellowship programs, but there are no appropriate models for specific surgical interventions, and high-fidelity models are not available or are costly. Therefore, this work's objective was to develop a pyeloureteral junction stenosis model, resembling the anatomical details and consistency of natural tissue, which is replicable and cheaper and can be used for simulating pediatric laparoscopic pyeloplasty. Its evaluation was done with a group of surgeons with different levels of training and surgical experience.

Materials and Methods

An experimental, cross-sectional, and quantitative study was designed to build a synthetic model of pediatric kidneys with pyeloureteral stenosis based on the analysis of anatomical details of magnetic resonance urography of a child (between 4 and 8 years of age) with the disease. The model was designed using the open-source software, Blender 2.91 (http://www.blender.org) and 3D Slicer 4.11 (http://www.slicer.org; Fig. 1).

FIG. 1.

Development of a simulation model of laparoscopic pyeloplasty. (A) Magnetic resonance urography images of a pediatric patient with pyeloureteral stenosis, (B) image processing in programs, (C) final appearance of the model, renal pelvis and right kidney for a patient with pyeloureteral stenosis; (D) structures in the simulation model: kidney with renal pelvis and ureter and inferior vena cava and abdominal aorta, covered with adhesive film representing the peritoneum; and (E) simulator and laparoscopy tower at the simulation laboratory of the Faculty of Medicine of the University of Antioquia.

This was a two-part model, including a three-dimensional (3D), printed, reusable plastic (polylactic acid) kidney and a single-use renal pelvis and ureter made of silicone and platinum cure silicone Dragon Skin™ FX-Pro, respectively. Artificial liquid food coloring (www.colorisa.com.co) was added to generate a light yellow color.

The pediatric simulator was built inside a generic mannequin torso representing the size of an 8-year-old child (approximately) and filled with self-expanding polyurethane foam to resemble retroperitoneal tissue. The simulator was lightweight, allowing the correct position for the intervention (lateral decubitus), and the access points in the anterior abdominal wall were made with silicone sheets 1–1.5 cm thick, allowing the placement of trocars and tensile points (Fig. 1).

The structures were fixed to the simulator for each practice with a magnet and coated with transparent polyurethane or yellow polyester adhesive film (3M™ Ioban™), simulating the peritoneum. Specific equipment and instruments required for laparoscopic surgery included a laparoscopic tower with a 30°, 5- or 10-mm lens, high-definition video with recording equipment, and a light source. For each practice, 5–0 monofilament sutures for the anastomosis (No. 2), 4–0 sutures for the traction points, one Double-J 3.4Fr stent, one 14-gauge catheter, and a 20-cc syringe for the leak test (the latter three are reusable) were used.

A pilot test was performed to make corrections to the model, and this was evaluated by a group of residents and specialists in pediatric surgery, laparoscopic surgery, oncologic surgery, and urology. Each participant was provided with information about the simulator as well as theoretical information on the pathology and procedure to be performed, the objectives of the practice, and critical steps to follow during the simulation (Fig. 2). Two short videos were shown, including pyeloplasty in a real patient and guidance of the procedure in the simulation model (Fig. 2E).

FIG. 2.

Steps of the practice performed in the model developed for pediatric laparoscopic pyeloplasty. (A) Dissection of the ureter and renal pelvis and the peritoneum (adhesive film), (B) point of traction in the renal pelvis through the abdominal wall, (C) resection of the pyeloureteral junction—stenosis zone, (D) ureteral spatulation on its lateral face, (E) traction point in the ureter, (F) anastomosis of the renal pelvis to ureter until the posterior face, (G) insertion of the Double-J stent through catheter No. 14 in the abdominal wall, and (H) anastomosis from the renal pelvis to the ureter is completed. (I) Anastomosis is completed when removed from the model.

The procedures were carried out at the simulation laboratory of the Faculty of Medicine of the University of Antioquia. We included surgeons and residents with any experience in basic laparoscopy and who were active in the field of pediatric surgery, general surgery, laparoscopic surgery, or urology. Those who did not complete the surveys were excluded.

Face validity and content validity assessments were carried out by registering opinions about the realism of the model, its content, and capacity for training, and type B construct validity assessment between groups of experts and nonexperts identified the ability of the model to distinguish between different levels of experience.^13–18 Given the variability in the definition of expert^1,7,19 and considering the scarcity of measurement data, the comparison was based on years of experience in laparoscopic surgery, prior experience in laparoscopic pyeloplasty, and level of training or rank of the participant.

The variables included were age, sex, dominant hand, years of experience in laparoscopic surgery, prior experience in laparoscopic pyeloplasty, and the number of laparoscopic pyeloplasties performed in the last year. Data gathered included procedure time in minutes, leak/stenosis test with water or methylene blue, and a semistructured, anonymous Likert survey on the model and perception of the procedure. The results were recorded in Google Forms™ (open-source app) and later in a Microsoft Excel™ sheet. Survey questions were about esthetics (thickness, appearance, color, consistency, and resistance), utility, and importance of the model.

The characteristics of participants were analyzed with the variables included. Continuous variables are described using medians and interquartile ranges or means and standard deviations according to their distribution. Categorical variables are described as frequencies and proportions. The comparison between groups for continuous variables was performed using the Mann–Whitney U test for two groups and the Kruskal–Wallis test for three or more groups, and categorical variables were compared using Pearson's chi-square test or Fisher's exact value. All statistical analyses were performed with STATA, V.14, software (StataCorp, College Station, TX, USA).

For the statistical analysis, participants were grouped according to previous experience in laparoscopic pyeloplasty (Group A) or no experience with the procedure (Group B); according to the years of experience in laparoscopic surgery of <10 years (nonexperts) or at least 10 years of experience (experts); and according to the level of training in residents (Group 1), pediatric surgeons and urologists (Group 2), and laparoscopic surgeons (Group 3).

The study was classified under resolution 008430 of 1993 of the Ministry of Health of Colombia and considered a risk-free study. Informed consent was obtained from legal guardians of children for the acquisition of images, and informed consent was also obtained from all participants. The project was approved by the program committee and research committee of the University of Antioquia.

Results

Twenty-four participants were included from July 2020 to February 2021, with a median age of 36 years (interquartile range [IQR] 31–44.5), 70.8% were men (ratio 2.4: 1) and 91.6% were right-handed. There were 2 urology residents, 4 pediatric surgery residents, 3 laparoscopic or oncologic surgery residents, 4 laparoscopic surgeons, 2 urologists, and 9 pediatric surgeons; 41.7% had prior experience in laparoscopic pyeloplasty, with a median of 2.5 laparoscopic pyeloplasties in the past year (IQR 2–8.75), and previous experience in laparoscopy of 5.5 years (IQR 2–7.75); 45.8% had <5 years of experience; and 25% had greater than or equal to 10 years of experience (Table 1).

Table 1.

Demographic Characteristics of the Participants

Variable	Total 24 (100%)
Participant—level of training, n (%)
Residents	9 (37.5)
Pediatric surgeons and urologists	11 (45.8)
Laparoscopic surgeons	4 (16.7)
Age (years)^a	36 (31–45)
Gender, n (%)
Female	7 (29.2)
Male	17 (70.8)
Dominant hand, n (%)
Ambidextrous	1 (4.2)
Right-handed	22 (91.7)
Left-handed	1 (4.2)
Years of experience in laparoscopy^a	5.5 (2–8.5)
Years of experience in laparoscopy, n (%)
<10 years	18 (75)
10 years or more	6 (25)
Experience in pyeloplasty, n (%)
No	14 (58.3)
Yes	10 (41.7)
Number of pyeloplasties/year (n = 10)	2.5 (2–10)
Number of pyeloplasties/year (n = 10), n (%)
<5	6 (60)
≥5	4 (40)
Pelvic traction point (Yes), n (%)	24 (100)
Ureteral spatulation (Yes), n (%)	24 (100)
Traction point in the ureter, n (%)
No	8 (33.3)
Yes	16 (66.7)
Stenosis (No), n (%)	24 (100)
Tear, n (%)
No	14 (58.3)
Yes	10 (41.7)
Double-J placement, n (%)
No	2 (8.3)
Yes	22 (91.7)
Completed the procedure, n (%)
No	2 (8.3)
Yes	22 (91.7)
Filtration, n (%)
No	14 (58.3)
Yes	10 (41.7)
Time (minutes)^a	72 (55–90)

Median (interquartile range).

There was a leak in 41.7% of cases, 2 participants did not complete the procedure for lack of adequate knot-tying skills, and there was no stenosis of the anastomosis in any case. (Table 2). The median time of the practice session was 72 minutes (IQR 55–90).

Table 2.

Comparison of Variables with Respect to the Presentation of Filtration

Variable	Total 24 (100%)	Filtration		P
Variable	Total 24 (100%)	No 14 (58.3%)	Yes 10 (41.7%)	P
Age (years)^a	36 (31–45)	40 (36–47)	31 (29–35)	.006
Gender, n (%)
Female	7 (29.2)	2 (14.3)	5 (50)	.075
Male	17 (70.8)	12 (85.7)	5 (50)
Dominant hand, n (%)
Ambidextrous	1 (4.2)	1 (7.1)	0
Right-handed	22 (91.7)	13 (92.9)	9 (90)	.670
Left-handed	1 (4.2)	0	1 (10)
Level of training, n (%)
Residents	9 (37.5)	2 (14.3)	7 (70)
Pediatric surgeons and urologists	11 (45.8)	8 (57.1)	3 (30)	.017
Laparoscopic surgeons	4 (16.7)	4 (28.6)	0

Median (interquartile range).

There was a statistically significant difference in the procedure time between nonexperts and experts (83 minutes versus 42 minutes, P: .003, respectively) and according to the level of training of the participant, with a median of 85 minutes for Group 1, 68 minutes for Group 2, and 40 minutes for Group 3 (P: .011). The group of experts (P: .022) and Group 3 (P: .017) had significantly fewer leaks compared with the other two groups. Table 3 compares the different groups.

Table 3.

Results Comparing Experts and Nonexperts, Construct Validity, and Objective

	Previous experience in laparoscopic surgery			Previous experience in laparoscopic pyeloplasty			Level of training of the participant
Group	<10 years	≥10 years	P	No	Yes	P	Residents	Pediatric surgeons or urologists	Laparoscopic surgeons	P
Outcome, n (%)	18 (75)	6 (25)		14 (58.3)	10 (41.7)		9 (37.5)	11 (45.8%)	4 (16.7)
Tear, n (%)	8 (44.4)	2 (33.3)	.506	6 (42.9)	4 (40)	.611	7 (77.8)	2 (18.2)	1 (25)	.025
Double-J stent placement, n (%)	17 (94.4)	5 (83.3)	.446	12 (85.7)	10 (100)	.330	9 (100)	10 (90.9)	3 (75)	.442
Filtration, n (%)	10 (55.6)	0	.022	6 (42.7%)	4 (40)	.611	7 (77.8)	3 (27.3)	0	.017
Time of completion^a	83 (65–92)	42 (39–60)	.003	65 (40–85)	77 (65–90)	.177	85 (80–110)	68 (65–90)	40 (37–42)	.011

Median (interquartile range).

The group of experts had the highest degree of symmetry and firmness of the knot, suture, and closure of the anastomosis, which are directly related to the absence of leaks and tears. No significant differences were found between groups A and B.

All participants completed the survey about the perception of the model and the simulation corresponding to face validation and the usefulness and importance of learning the skills required to complete the procedure or content validation (Fig. 3).

FIG. 3.

Likert surveys conducted on participants and face and content validity (subjective). P, professionals; T, trainees.

The cost for the model, including the reusable structure, pediatric simulator developed for practice, and interchangeable structure, was low, costing Colombian pesos (COP) 109,000 (US$28.41) for the reusable structure, with each additional practice costing COP 4000 (1.04 USD September 2021), compared with a suture simulator available on the market for between COP 100,000 and COP 300,000 (26.06–78.18 USD). The total cost of the simulator was COP 235,500 (US$61.24) compared with a simulator on the market costing 3,500,000 COP or US$912.11.

Discussion

This study allowed us to develop a 3D, printed synthetic model of a patient with pyeloureteral stenosis to simulate laparoscopic pyeloplasty in pediatric patients. The use of image evaluation and 3D printing confers greater fidelity^13,20 with specific anatomical relationships of the pathology. This technology has also been described for surgical planning and training of rare and complex procedures.^13,21 The interchangeable silicone segment from an actual patient's image reproduces the esthetics of the structures and allows more surgical attempts at a low cost.^4,11,22

Synthetic models have the advantages of being reusable, usually portable, and easily accessible, with minimal risks and without the limitations of biological models, which include ethical issues in using living animal models or the need for preservation of animal parts.^23–25 High-fidelity synthetic models are expensive,²⁰ and low-cost models are often unrealistic despite their practicality and availability.²⁶ In this case, an unexpensive model was created while maintaining fidelity.

On the other hand, virtual simulators recreate real scenarios with sequenced learning to achieve the objectives of basic techniques and complex cases¹³; their effectiveness depends on the software's design and validation and can be improved through haptic interfaces that allow movement feedback. High-fidelity systems and complex procedures imply high costs and difficulty in acquiring them, limiting their usefulness and availability.^27,28

Several porcine and chicken models for laparoscopic pyeloplasty have been described and are applicable for developing skills at low cost.^29–31 A review by Villamizar and colleagues found 17 model studies for laparoscopic pyeloplasty; 70.6% of biological models included pig kidneys or intestine and chicken esophagus, intestine, crop, and skin and 29.4% of artificial models used silicone, a latex glove, and a plastinated kidney. They evaluated surgical realism, usefulness, esthetics, and operative time and found that all models decreased the intervention time matching the open intervention.³

The preparation time for our model varies from ∼30 to 60 minutes, which is greater than that reported in a biological model (6–14 minutes).²⁹ The procedure was performed using the laparoscopy tower available at the simulation laboratory of the Faculty of Medicine of the University of Antioquia, managing to realistically recreate the environment and equipment to be used.

The simulation seeks to provide better care and safety for the patient by improving surgical skills in a controlled space and recreating specific conditions, which are of particular interest in children.³² Given the increase of these simulators, it is essential to ensure their quality and include them in curricular programs. This study included face and content validity assessment through a semistructured Likert survey with excellent results and high acceptability by surgeons and residents.

The median time for the simulation was 72 minutes (IQR 55–90), with statistically significant differences between the groups and greater variability in the time taken by the group of nonexperts or residents (Group 1). This is unlikely to be comparable with other studies, considering the differences in surgical steps. A time of 43–65 minutes has been described for an animal model²⁹ and 47–160 minutes for the latex glove model, also with a difference between expert and nonexpert groups.²⁶ Panek et al described an average time of 155 minutes (88–350) for the procedure in patients.⁷

One of the lead causes for longer times in our model was the difficulty in placing the Double-J stent. It has been demonstrated that repeated practice can shorten the operation time and improve suture firmness.³³ However, this was not evaluated in this work.

Subjectively, the anastomoses performed by the expert group and Group 3 were better than those performed by nonexperts, based on symmetry, esthetics, knot firmness, and closure of anterior and posterior walls. Due to technical difficulties, videos of all the practice sessions were not available for an objective double-blind analysis using the Objective Structured Assessment of Technical Skills scale³⁴ or implementation of educational strategies such as the black box,³⁵ which is proposed for subsequent works.

This model has a training purpose, providing feedback to the trainee and at the same time monitoring their progress as a learning tool before the procedure in the patient. This type of training has been shown to improve surgical skills.^36–38 It does not mean that simulation can replace traditional training, but it should be included in the preparation process with defined goals, leading to successful training.^12,39 Therefore, simulation should be included in a structured program or curriculum to acquire knowledge, attitude, and ethics and develop psychomotor skills.⁴⁰

This study demonstrates that the developed model is helpful in preparing residents and surgeons for performing ureteropelvic anastomosis, highlighting the technical aspects of pyeloplasty. It has significant advantages over equivalent animal or synthetic models, given its low cost and fidelity of the represented disease.

The main difficulty with the model was achieving an adequate thickness of the disposable structures, being variable, more fragile, and thinner in some cases, making them susceptible to tearing, which happened mainly in the group of residents (77.8%, P: .025); or thicker, with unrealistic consistency. Another difficulty was placement of the Double-J stent, which was not achieved in two cases, primarily due to the propensity of the ureter to collapse in the distal segment and its angulation or obstruction when joining the rigid segment. Despite this, most participants felt that it was a valuable model for the intended goal and easy to replicate and that they would like to repeat the experience.

The model's limitations do not include pneumoperitoneum, entering the abdominal cavity, bleeding, or surrounding anatomical structures since it focuses on the anastomosis process. The asymmetric distribution between experts and nonexperts, the vague definition of expertise, the lack of experts in pediatric laparoscopic pyeloplasty in our setting, and the lack of prior objective measurement of basic skills of the participant were other limitations. Another limitation was the lack of video recordings, which would have been helpful to perform a blinding analysis.

The expected number of participants was obtained, although a future study with more participants and validation of the model could have more robust results. There were some difficulties with the inability to coordinate participants and biosafety protocols of the simulation laboratory in the middle of the COVID-19 pandemic.

Other studies report the limitation of pediatric surgery residents to attend academic activities due to clinical responsibilities and the low exposure to minimally invasive techniques.³⁸

These results open an opportunity to include this type of training in curricular programs (where only time is required), with expert mentors in laparoscopic surgery, and the possibility of including virtual training for better outcomes. As a result of the COVID-19 pandemic, with the limitation of the number of cases and learning opportunities, the use of alternative educational tools has accelerated, with preoperative exercise training, video-based feedback, and telesimulation.^21,35,41

Conclusions

A high-fidelity, replicable, and low-cost pyeloureteral stenosis model was developed from the images of a patient with pyeloureteral stenosis and 3D printing, which allows reproducing the simulation of laparoscopic pyeloplasty in pediatric patients. The preliminary face, content, and construct validity assessments between groups were examined, demonstrating its capacity as a helpful tool for surgical education and training of residents and professionals in performing ureteropelvic anastomosis in laparoscopic pyeloplasty in pediatric patients, considering the scarce exposure to actual patients during residency programs.

This model is a suitable alternative for the learning process, between using low-fidelity models and task trainers and performing live patient surgery, achieving many of the skills in a controlled environment and aiming for patient safety.

Footnotes

Acknowledgments

The authors would like to thank Alejandro Mesa for the 3D design and printing of the reusable structure; Juan M. Robledo for reviewing and editing the draft and building the model; Carlos G. Correa for building the model; and Johana Ascuntar for the statistical analysis.

Authors' Contributions

J.C.R. was involved in conceptualization (lead); investigation (equal); methodology (lead); writing—original draft (lead); and writing—review and editing (equal).

W.R.E. and A.C.A. were involved in conceptualization (supporting); methodology (supporting); supervision (equal); and writing—review and editing (equal).

A.M.M.B. was involved in conceptualization (supporting); methodology (supporting); investigation (equal); and writing—review and editing (equal).

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

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