A Simulation Model to Support Laparoscopic ...

JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES Volume 28, Number 6, 2018 ª Mary Ann Liebert, Inc. DOI: 10.1089/lap.2017.0263

A Simulation Model to Support Laparoscopic Pyloromyotomy Teaching Quentin Ballouhey, MD,1 Liviu Micle, MD,1 Ce´line Grosos, MD,1 Yohan Robert, MD,2 Aure´lien Binet, MD, PhD,3 Alexis Arnaud, MD,4 Olivier Abbo, MD, PhD,5 Hubert Lardy, MD, PhD,3 Bernard Longis, MD,1 Jean Bre´aud, MD, PhD,6 and Laurent Fourcade, MD, PhD1

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Abstract

Introduction: A key concern regarding laparoscopic pyloromyotomy (LP) lies with the process of learning this skill. The learning processes for open pyloromyotomy and LP appear to be different, with an earlier increased risk of perforation or incomplete pyloromyotomy (IP) for LP. Our aim was to develop a simple simulation tool to reduce these specific complications. Materials and Methods: A model of hypertrophic pyloric stenosis was created and inserted into a pediatric laparoscopic surgery simulator. A cohort of experts completed a six-item questionnaire, using a 4-point scale regarding the model’s realistic nature and accuracy. Evaluation of the LP procedure was based on a dedicated Objective Structured Assessment of Technical Skills score. Surgical residents and students were enrolled for the final evaluation to assess the relative performance of trainees who had practiced with this model (Group 1) versus those who had observed its use (Group 2). Results: Reproducibility of the model construction was considered to be satisfactory. The experts agreed that the model accurately simulated essential components of LP (mean 3.03 – 0.7). They scored significantly better than the residents (27.2 – 1.8 versus 22.8 – 2.9; P < .001), with a lower rate of complications. Group 1 (39 trainees) performed significantly better than Group 2 (26 trainees), with a significant decrease in the risk of an IP (P < .05). Conclusions: This model appears to be sufficiently accurate to teach LP. In light of this, it can be considered to be an efficient tool for LP simulation teaching in our fellows’ educational program. Keywords: pyloromyotomy, laparoscopic, simulation, teaching

Introduction

A

laparoscopic pyloromyotomy (LP) approach for the treatment of hypertrophic pyloric stenosis (HPS) was first described 25 years ago.1 This technique has been taught extensively throughout the world, and its merits have been extensively documented.2 The potential advantages of LP are shorter hospital stays, improved cosmetic outcomes, and less postoperative pain. A key issue regarding LP is with regard to the process by which this surgical technique is learned. Surgical procedures, and especially laparoscopic procedures, need to be undertaken a minimal number of times before the techniques

can be safely performed and a performance plateau is reached by the whole surgical team. Oomen et al.3 demonstrated that after 35 LP procedures, the occurrence of complications decreased dramatically. The learning processes with regard to open pyloromyotomy and LP surgeries appear to be different, with the latter being associated with a higher and earlier increased risk of specific complications such as mucosal perforation (MP) or incomplete pyloromyotomy (IP). The learning process for the LP technique continues to be an issue of concern, and an investigation of individual skill levels during the learning process4 has reported that the risk of specific complications was particularly high during the first 10 procedures.

1

Service de Chirurgie Visce´rale Pe´diatrique, Hoˆpital des Enfants, Limoges, France. Service de Chirurgie Pe´diatrique de Grenoble, Faculte´ de me´decine de Grenoble-Alpes, Grenoble, France. Service de Chirurgie Pe´diatrique de Tours, Faculte´ de me´decine de Tours-Franc¸ois Rabelais, Tours, France. 4 Service de Chirurgie Pe´diatrique de Rennes, Faculte´ de me´decine de Rennes-1, Rennes, France. 5 Service de Chirurgie Pe´diatrique de Toulouse, Faculte´ de me´decine de Toulouse-Paul Sabatier, Toulouse, France. 6 Service de Chirurgie Pe´diatrique de Nice, Faculte´ de me´decine de Nice-Sophia Antipolis, Nice, France. A video demonstrating this technique is available at www.liebertpub.com/lap 2 3

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FIG. 1. Design of the study. The model was tested with a three-phase study pattern. Models of hypertrophic pylorus stenosis were tested by pediatric surgeons as the first phase. The accuracy of the LP model was then assessed by experts before the contribution of its educational value was evaluated by comparing two groups with different levels of training with the model. HPS, hypertrophic pylorus stenosis; LP, laparoscopic pyloromyotomy. This degree of risk is generally not acceptable to patients and their parents, whereas from a surgical point of view, the elevated risk can be a source of considerable stress. In light of this, we are proponents of early and effective simulation teaching, in addition to surgical supervision for trainees, with the aim of decreasing the rate of early complications. Simulator teaching of LP has not been widely used to date for a variety of reasons, such as the accessibility of simulators in particular. Although our surgical task performance simulator5 has yielded encouraging results, one of the reasons it did not undergo full development was that it was not readily reproducible. Our aim was hence to develop an efficient and reproducible simulation tool for teaching LP surgery techniques. The underlying intention was to reduce specific LP-related complications.

and the overall accuracy of the model. A dedicated Objective Structured Assessment of Technical Skills (OSATS8; maximal score = 35) score was used to evaluate the procedure: POSATS (Pyloromyotomy OSATS score) (Supplementary Data S2). This score focused above all on qualitative parameters, although it also took into account quantitative parameters, such as the time to completion. It aimed to differentiate the performance of experienced surgeons and residents, with attention being given to instances of MP and IP in particular. For this purpose, the model was carefully examined at the end of the procedure. The first phase was the validation by the experts (Fig. 1). A cohort of pediatric surgeons were recruited who, given their extensive experience with LP, were considered to be referents in this area. They were asked to individually test the model at the 2016 French endoscopic surgeons’ annual GECI meeting,

Materials and Methods

A reproducible model of HPS was generated using basic materials (Supplementary Data S1; Supplementary Data are available online at www.liebertpub.com/lap) that approximate the stomach and the swollen pylorus. This model was placed in a pediatric laparoscopic surgery simulator6 so as to replicate a standardized workspace. The principle was to preferentially use readily available materials and a validated training box6,7 to make this model reproducible worldwide and at a minimal cost. Laparoscopic 3 mm instruments (i.e., forceps, knife, and spreader [ref 26180 VD and 26167 DFS, STORZ]; Gmbh&Co, Germany; and a camera (Quickcam-Logiteck; Carl Zeiss AG, Germany) were used. A short training session was devised, focusing on the three consistent steps of LP: a linear cut in the serosa, splitting of the muscle to begin the myotomy, and completion using the spreader (Supplementary Video S1. Supplementary Data are available online at www.liebertpub.com/ lap). A preliminary study with 3 experts confirmed the feasibility

FIG. 2. Model of HPS. (A) A cross-section of the original model. (B) The models reproduced by the pediatric surgeons of other centers. The reproducibility of the HPS model was deemed to be adequate. HPS, hypertrophic pylorus stenosis.

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Table 1. The Experts’ Level of Agreement Regarding the Model’s Level of Accuracy Level of agreement of the 15 experts Strongly disagreed

Disagreed

The current HPS model accurately simulates the following items Difficulty in holding the duodenal 0 1 (7%) Required depth of the serosal layer cut 0 1 (7%) Difficulty in initiating spreading 0 2 (13%) Required strength for spreading 1 (7%) 6 (40%) The current HPS model is a good support for teaching pyloromyotomy to Beginners 1 (7%) 3 (20%) Pediatric surgeons 0 3 (20%)

Agreed 8 12 9 5

(53%) (80%) (60%) (33%)

5 (33%) 8 (53%)

Strongly agreed 6 2 4 3

(40%) (13%) (27%) (20%)

6 (40%) 4 (27%)


The 4-point Likert scale for the model’s accuracy, and the extent to which it reflects actual surgical conditions. HPS, hypertrophic pyloric stenosis.

after a standardized explanation and individual explanatory demonstrations. After having tested the model, they were asked to complete an anonymous six-item questionnaire, using a 4-point Likert scale regarding the accuracy of the model and the extent to which it reflects actual surgical conditions. The second phase aimed to evaluate the reproducibility of the HPS model assembly. A ‘‘do it yourself simulation kit’’ of HPS with associated instructions was sent to less experienced surgeons and residents of other pediatric surgical centers. It was requested that they return the results of their efforts with any eventual comments for an overall evaluation. The last phase consisted of recruiting trainees to test the LP simulator. Participants were enrolled once they had signed consent forms and after approval was obtained from the Institutional Review Board. Two different groups were enrolled for the final testing phase of this model, comprising surgical residents from the general surgery program and fourth-year medical students. Before undertaking training, they completed a questionnaire regarding their level of experience with laparoscopy and their knowledge of LP. Preliminary standard oral explanations were provided, including

a didactic overview of the HPS, an explanation of how the current model works, and narrated videos of LP. The subjects participated individually in the training. They were divided into two groups. Group 1 performed the LP simulation using the current model immediately (session 1) and after a 3-month period of inactivity (session 2). Group 2 observed the simulation process at session 1 and performed the LP simulation at session 2. All of the participants completed a multiple-choice test questionnaire at session 2 to assess the acquired cognitive information regarding LP. Evaluation of the LP procedure was performed by 2 independent researchers using both OSATS and POSATS scores. Data were recorded and collected by the 2 reviewers. A previous pilot study (unpublished data) had yielded a mean POSATS score of 25 for the experts (standard deviation = 2) and a score of 20 for the residents (standard deviation = 3). Using these data as a base, and seeking to demonstrate a difference of at least five points between the score for the experts and the residents, with an a-risk of 5% and a b-risk of 20%, we determined that this study would need a minimal total recruitment of 12 participants

FIG. 3. Detailed performances by the experts and the residents. Specific POSATS score details highlighting each mean item score, with standard deviations, according to the level of expertise. Experts scored significantly better for each item. POSATS, Pyloromyotomy Objective Structured Assessment of Technical Skills.

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Table 2. Mean Specific and Overall Scores According to the Medical Trainee Level Level of medical training Number of subjects

Students (30)

Residents (35)

Experts (15)

Scores

Mean – SD

Mean – SD

Mean – SD

ANOVA P-value

IP MP POSATS total OSATS score

2.6 – 0.6 4.5 – 0.8 18.6 – 2.4 17.4 – 2.8

3.4 – 0.7 4.3 – 0.7 22.8 – 2.9 25.4 – 3.4

4.5 – 0.5 4.9 – 0.5 27.2 – 1.8 30.6 – 2.6