Method Article

Utilizing a 3D Printed Laparoscopic Nissen Fundoplication Model to Shorten a Resident's Learning Curve

DOI:

10.3791/68369

⸱

August 15th, 2025

 ,  ,  ,  ,  ,  ,  ,  ,  ,  , 
1General Surgery, Cancer Center, Department of Hernia Surgery, Zhejiang Provincial People's Hospital, 2The Second School of Clinical Medicine, Zhejiang Chinese Medical University, 3International Education College Zhejiang Chinese Medical University, 4School of Basic Medicine and Law, Hangzhou Medical College, 5School of Basic Medical Sciences and Forensic Medicine, Hangzhou Medical College

* These authors contributed equally

In This Article

Summary

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This study describes how 3D printed models effectively accelerate the rate at which advanced laparoscopic surgery skills used in Nissen Fundoplication are mastered by surgical residents during residency training, thereby enhancing future preparedness.

Abstract

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Laparoscopic Nissen fundoplication (LNF) requires extensive training for surgical proficiency, with significant early learning curve complications. A structured training protocol utilizing a 3D-printed anatomical model is described and designed to accelerate the acquisition of advanced laparoscopic skills. The protocol entails the production and assembly of models incorporated into an LNF-specific training curriculum focused on critical components involving advanced suturing skills. The model includes anatomically accurate landmarks, all fabricated using specialized silicone materials. A step-by-step training curriculum is presented, focused on mastering the most challenging components of LNF, including crural closure, mesh suturing, and the fundoplication wrap. Representative results from a pilot participant demonstrate a quantifiable learning curve, with total performance scores improving from 21 to 42 and procedural time decreasing from 95 to 34 min across six sessions, systematically approaching the expert benchmark. The overall efficacy of this training paradigm was validated in a comparative study, where the 3D-printed model-trained group demonstrated significantly superior Objective Structured Assessment of Technical Skills (OSATS) scores in the operating room (26.25 ± 1.67 vs. 17.50 ± 2.07) and shorter procedure durations (76.25 ± 2.49 vs. 110.13 ± 3.36 min) compared to a control group, confirming the protocol's positive impact on clinical skills. This validated protocol provides a reproducible method for implementing an effective LNF training program capable of measuring and facilitating progressive skill development.

Introduction

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Laparoscopic Nissen fundoplication (LNF) has emerged as the gold standard surgical intervention for gastroesophageal reflux disease (GERD)1, increasingly supplanting lifelong medical anti-reflux therapy. LNF's technical complexity necessitates a steep learning curve, with a minimum of 20 procedures for achieving surgical proficiency2. Significantly impacting patient outcomes3 with complication rates ranging from 24% to 55% during a surgeon's initial procedures4,5,6, particularly within the first five operations. Subsequent evidence demonstrates a decline in complications to approximately 10% during procedures 15-254,6. The most common complications reported during the initial 20 cases predominantly involve deficiencies in technical skills; specifically, challenges with dissection of the posterior window of the oesophagus, short gastric vessels division and fundal mobilization, closure of the diaphragmatic crura, and suturing of the fundoplication7,8. Mastering these steps correlates with reduced complication rates of 2%-10%3,8,9.

Currently, surgical education presents multiple simulation training platforms to enable trainees to overcome the learning curve quickly10. However, a standardized curriculum for advanced laparoscopic training remains unestablished11,12,13,14. Evidence demonstrates that residency program completion frequently results in insufficient confidence for independent advanced laparoscopic procedure execution, necessitating fellowship pursuit for technical proficiency acquisition15. Importantly, despite the establishment of the Fundamentals of Laparoscopic Surgery (FLS) implementation in residency programs, studies have identified significant disparities between residents' simulation-based intracorporeal suturing proficiency and operative room (OR) performance, suggesting that an intermediate training platform is warranted to bridge the gap between the FLS and OR suturing16. Moreover, after achieving proficiency in FLS, there is a clear need to improve the skills and confidence of surgery residents prior to their graduation with respect to advanced laparoscopic surgery, beyond FLS.

To address this, technological advancements have presented potential training solutions. Dry lab simulators such as Virtual Reality (VR) offer detailed anatomical representations and deliberate practice opportunities characteristic of LNF17. However, the cost of establishing and maintaining a VR simulator lab is a significant challenge18. Traditional wet lab simulators encompassing cadavers and live animal models, while optimal proctors for many procedures, present limitations in anatomical fidelity, ethical and health safety protocols19, especially pertinent in post-COVID-19 contexts alongside cost, logistical, and scheduling challenges10,20.

To offer an alternative, we developed an anatomical model of the upper abdomen utilizing three-dimensional (3D) printing technology based on an actual CT-modeled reconstruction and silicone material fabrication for LNF training. This model offers high reusability, with key components like the peritoneal layer and short gastric vessels replaceable after multiple practice sessions, and individual training sessions typically involving up to 8 attempts. Validation studies of comparable self-manufactured models have demonstrated significant efficacy in operative skills acquisition, as documented by Wang et al.21 and A.ghazi et al.22.

This 3D printed model can be combined with an instruction video and step-by-step demonstration videos to potentially mitigate early learning curve challenges in the clinical setting. This study aimed to demonstrate the efficacy and implementation of this training paradigm for LNF skill acquisition.

Protocol

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This study was approved by the Zhejiang Provincial People's Hospital Institutional Review Board and conducted in accordance with established ethical guidelines. Written informed consent was obtained from all human participants. The reagents and equipment used are listed in the Table of Materials.

1. Preparing the 3D printed LNF model

NOTE: The process of fabricating individual 3D-printed anatomical models with silicone has been discussed in detail in the previous report21.

  1. Perform 3D computed tomography scanning with a slice thickness of 0.5 mm.
  2. Obtain Digital Imaging and Communication in Medicine (DICOM) profiles of the specific organ.
  3. Convert DICOM profiles to STL format. Import the files into Magics 24 software (File > Import). Repair the model as needed by running automatic fixing (Path: Menu bar > Fix > Auto Fix), performing partial manual fixing (Path: Menu bar > Fix > Manual Fixing), and removing noise shells and debris (Path: Menu bar > Fix > Remove Noise Shells).
  4. After repairing, add support structures (Path: Menu bar > Orientation > Create Support). Finally, export the repaired and supported model, performing cut layer export as needed (Path: Menu bar > File > Export > STL).
  5. Use an SLA 3D printer to create the organ (liver) mold. Apply the following operational settings for precise mold fabrication: Squeegee start height: 4.5 mm, Squeegee speed: 60 mm/s, Z-axis speed: 2 mm/s, Temperature control: 30 °C, Curing speed: 0.2 mm/s, Spot size: 0.07 mm, and Layer thickness: 0.1 mm.
  6. Clean the printed mold thoroughly in an ultrasonic cleaner using ethanol solvent at 40 kHz for 3-5 min.
  7. Complete secondary curing of the mold in a UV chamber. Ensure exposure to UV light with a wavelength of 405 nm at an intensity of 30 mW/cm2 for a curing time of 30 min to achieve full curing.
  8. Prepare two-component 0-degree silicone (Guoyuan Mix 750 g of Component A and 750 g of Component B). Place the mixture in an ambient temperature controlled at 22-25 °C to avoid high temperature affecting the operational time.
  9. Place the mixture in a vacuum chamber to remove air bubbles. Set the vacuum level to -0.09 MPa for a defoaming time of 8 min.
  10. Pour the prepared silicone from the vacuum chamber into the organ (liver) mold. Observe to ensure the silicone fills the mold evenly and that no large air bubbles are visible on the surface.
  11. Allow for complete curing. This process should be carried out in an airtight environment at a temperature of 25 °C ± 2 °C for 1 h to ensure molding quality.
  12. After complete curing, apply a thin layer of petroleum jelly to the inner surface of the mold components to act as a release agent and carefully remove the mold to obtain the final silicone organ (liver) model.
  13. Check that the surface of the model is complete and that the anatomical structures remain clear. If the surface has collapsed or contains significant bubbles, the model should be remolded.
    NOTE: This procedure is repeated for each organ, leading to the assembly of the LNF model (Figure 1).

2. Assembling the LNF model

  1. Place the 3D printed organ models as per the corresponding anatomical layout.
  2. Lay out the oesophagus attached to the stomach, entering the mediastinum through the opening between the crura and gastric fundus.
  3. Place the omentum, liver, and bile duct adjacent to the stomach, holding them up by pins. These parts are important in both visual and tactile aspects of the training for LNF.
  4. Place the skin onto the plastic platform, securing it with velcro and pins. Connect a light located within the platform to a power source to improve the lighting.
  5. Make 3 incisions on the skin for ergonomic trocar positioning. Establish the triangle of vision by inserting a 5-mm trocar for the 30-degree laparoscope at the center, with two 10-mm trocars on both sides for laparoscopic needle drivers, atraumatic graspers, and laparoscopic scissors.
  6. Secure the laparoscope using a clamp, and attach it to the USB port of a high-definition display screen on either a TV or laptop.
  7. Place a 2-0 silk suture within the model with a CT-1 needle.

3. Training curriculum

NOTE: The procedure is divided into five component tasks, with the importance of each task being preclinically determined by prior studies21,23. Crural closure and mesh suturing are foundational for large hiatal hernia repair, together with the limitations of the model itself.

  1. Cut open the silicone gel layer around the oesophagus to establish the posterior oesophagus tunnel. Ensure clear visualization, mobilizing the esophagus circumferentially for a length of at least 4-5 cm, with attention to the right and left crura of the diaphragm.
  2. Identify and suture the bilateral diaphragmatic crura with three interrupted sutures. Verify that the crura are securely closed without tension, ensuring adequate approximation of the diaphragmatic pillars.
  3. Correctly place the mesh and suture its sides symmetrically on the diaphragm. Confirm even placement and secure attachment of the mesh to the diaphragm, ensuring it lies flat without wrinkling and maintains a clear margin from the esophageal wall.
  4. Properly execute the 'shoe shine manoeuvre' and align the gastric fundus to wrap over 2-3 cm of the oesophagus. Ensure a floppy, tension-free, 360-degree fundoplication wrap that is no more than 2 cm in length.
  5. Properly ensure closure of the wrap with three interrupted sutures over a length of 1.5 cm. Verify secure and consistent suture placement to maintain the integrity of the fundoplication, ensuring the wrap is not too tight by passing a bougie.
    NOTE: Prior to the training, a step-by-step expert demonstration of the LNF on the 3D model is video recorded. This expert's video is timed and scored, providing the baseline/target performance metric. All training sessions are to be recorded; feedback is to be provided after every session by the expert surgeons. Training attempts are capped at eight attempts (Figure 2). The control group continues the normal rotation with no additional training on the 3D printed model.

4. Recruiting participants

  1. Recruit novice surgeons with Fundamentals of Laparoscopic Surgery (FLS) certification but no advanced laparoscopic surgical skills experience, and expert laparoscopic surgeons (>100 Nissen Fundoplication).
  2. Assign the novice surgeons randomly to an experimental and a control group.
  3. Adhere to the training curriculum.

5. Assessing the performance

NOTE: An expert surgeon scored all training session videos based on the five-component procedure-specific score, which was adopted and modified from a previous study23, and is included in the Supplementary File 1.

  1. Conduct a final assessment on live operating room (OR) performance under expert surgeon supervision, which will be evaluated in real-time using the identical checklist.
  2. Additionally, assess the 3D printed LNF model training platform.

6. Data analysis

  1. Measure all outcomes, including overall technical performance scores, procedure-specific checklist scores, procedural completion time, learning curve trends, and 3D printed LNF training platform validity.
  2. Create a table with raw data from all experimental and final performance steps. Calculate both the mean and standard deviation of the experimental and control group.
  3. Perform statistical analysis using appropriate tests.
  4. Generate graphs visualising the learning curve progression, performance metrics comparisons using appropriate graphing software.

Discussion

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These 3D printed models allow the training and assessment of essential key techniques crucial for an ideal LNF, such as crural closure with creation and execution of a fundal wrap around the oesophagus. This is crucial as studies have demonstrated that both the length and tightness of a fundoplication strongly influence the distal oesophageal sphincter pressure, potentially elevating it up to three times its preoperative levels, which may lead to dysphagia25. As demonstrated, the resident's performance trajectory from the early training sessions to the final operating room performance showed significant improvement. The procedure time closely approached the expert's benchmark of 34 min. This marked improvement in technical proficiency was observed through iterative training sessions.

The 3D printed model offers the opportunity to practice procedure-specific advanced laparoscopic surgical skills in a safe, controlled environment26,27. The use of these models for training purposes has gained traction over the past decade, with Zhu et. al. demonstrating their adequate realism, cost effectiveness, sustainability, and capacity for maintaining operative skills acquisition for training of medical students11. Multiple studies have confirmed the realism and application of these models' fidelity through simulation programs, validity studies, and participants' feedback21,22,28.

Analysis of training sessions revealed high standard deviations, especially during the earlier training sessions, training 1&<2, indicating performance inconsistencies across the assessed metrics. This variability highlights the importance of model design optimization, as some tasks involving intracorporeal suturing, such as crural closure score and mesh fixing score, were lower compared to fundoplication and inspection scores. This disparity reflects the increased complexity and learning requirements for specific technical skills within one procedure. Prior studies corroborate this relationship and offer evidence showing task-specific metrics could be used to differentiate between different surgeon levels. Xia et al. showed this distinction utilizing 3D printed models to simulate laparoscopic intracorporeal intestinal anastomosis using a modified anastomosis objective structured assessment of technical skills to help distinguish expert, intermediate, and novice surgeons29.

The performance variability, especially in technical manoeuvres posed by intracorporeal suturing, highlights the need for procedural troubleshooting. For trainees struggling, expert proctors can ensure additional targeted drills on specific weaknesses, which is more effective than simple repetition. The design of the models allows for easy reusability and repeatable exercise, unlike animal organs and living tissue, which present storage challenges or reusability due to animal tissue friability, making them less cost-effective. With the 3D model, the peritoneal layer over the crura and the omentum, with the short gastric vessels, are the only things that should also be replaced after multiple practices. Furthermore, its low-cost production is maintained as the current material used is silicone, making it affordable30. To address the model's reusability, we must consider its durability. While formal mechanical testing was not a part of this study's protocol, we made several observations based on informal experience during repeated training sessions. We noted that durability depended heavily on the participant's technique. For crural repair, a single model could typically accommodate approximately 10 suture placements before cumulative damage from needle penetration necessitated replacement. For fundoplication training, the limiting factor appeared to be mechanical stress from suture tension; the model generally withstood 6-8 instances of strong pulling force before showing signs of structural damage. Based on this observation, trainees should be instructed to apply moderate, controlled tension, as excessive pulling can cause premature model failure and does not reflect appropriate surgical technique. There is further research exploring the use of advanced materials like hydrogel polymers to further increase realism and enable the ability of perfusion and more advanced laparoscopic techniques, such as cautery24,31. Nevertheless, the low maintenance cost per training, portability, and easy preservation ensure its accessibility to all training centres, schools, and hospitals.

The study's most critical validation suggests that the 3D-printed model training offers exceptional potential in bridging the gap between simulation-based training and actual operating performance. Previous studies have mentioned the need to showcase transferability as it would not only encourage usage but also offer great insight into its application in an actual live operation and patient outcomes32. It is imperative to acknowledge the inherent exploratory nature of utilizing 3D printed models in advanced suturing training. While statistically significant findings are encouraging, they necessitate cautious interpretation, requiring further validation with a larger cohort for more statistically definitive conclusions.

Possible limitations to these models include the design being as realistic as animal tissue; intricate anatomical features, which might be encountered in surgery, such as greater omentum, endothoracic fascia, endoabdominal fascia, mesoesophagus, and vagus nerve, were not included. However, certain design choices were deliberately made to increase the training's rigor and applicability. The curriculum focuses on hiatal hernia repair requiring mesh because mastering these complex techniques provides residents with the skills necessary to handle any type of hernia. Furthermore, the intentionally confined workspace prepares trainees for the most spatially challenging abdomens, ensuring their skills are robust and adaptable. Another question that arose was whether the number of laparoscopic cases or the quality of training made the residents better. Traditionally, the more laparoscopic cases a resident performs in their training, the better their skills get. However, as is evident, the duration spent in the skills laboratory is similarly invaluable, particularly relevant for residents with limited early exposure to advanced laparoscopic procedures33.

Future research should also focus on a formal cost-effectiveness analysis, weighing the cost of this training program against the financial impact of longer OR times and managing postoperative complications. Furthermore, the ultimate goal is to validate that proficiency on this 3D model directly translates to improved patient outcomes, which would require a long-term study tracking metrics like operative time, complication rates, and hernia recurrence for patients of trained residents. Future work could involve standardized material fatigue analysis to provide quantitative data for the durability claim.

In summary, 3D printed models represent cost-effective, customizable, efficient tools that have a distinct effect in helping reach learning curves in a more expedited fashion. Impacting the clinical surgical education and patient outcomes.

Disclosures

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The authors declare that they have no conflict of interest. This article does not contain any studies on animals. This work was supported by the fund of The Science and Technology Cooperation Project of Zhejiang Provincial Department of Science and Technology (2024C04027) and The Special Project for Key R&D Tasks of the Xinjiang Uygur Autonomous Region (Project No.2023B03010-1).

Acknowledgements

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The authors would like to acknowledge the support of the Department of Hernia Surgery of Zhejiang Provincial Peoples Hospital for the opportunity to conduct this research project.

Materials

List of materials used in this article
NameCompanyCatalog NumberComments
Graphing Software GraphPad PrismGraphPad PrismPrism 10Used for graph generation https://www.graphpad.com/scientific-software/prism/
Graspers Atraumatic graspersKangji101.096, Ø5.5×460mm, or 108Y.208 (22mm jaw)Standard laparoscopic instruments https://www.kangjimed.com/products
Laparoscope 10-mm 30-degree laparoscopeKangji130.032A Φ5×300mm 30°Standard laparoscopic equipment https://www.kangjimed.com/products
Needle Drivers  Laparoscopic needle driversKangji 101.029, Ø5×330mmStandard laparoscopic instruments https://www.kangjimed.com/products
Scissors Laparoscopic scissorsKangji101.032A StraightStandard laparoscopic instruments https://www.kangjimed.com/products
SiliconeGuoyuanNot specifiedSLA printing material
SLA 3D PrinterUnionTechLite800Large-format professional SLA 3D printer https://www.uniontech3d.com/products/lite-800-industrial-resin-sla-3d-printer/
Statistical Software SPSSIBMversion 25.0Used for data analysis https://www.ibm.com/products/spss-statistics
Sutures  Ethibond suturesEthiconG680H for 2-0 Ethibond2-0 Ethibond with CT-1 needle https://www.ethicon.com/na/epc/search/platform/wound%20closure
Ultrasonic cleanerDingyuDY-020Used for cleaning printed parts
UV curing chamberDHCDHC48Used for post-processing
Vacuum chamberJunzai5305-0609Used for post-processing

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Tags

3D Printed ModelSurgical SimulationResident TrainingLaparoscopic SuturingCrural ClosureMesh SuturingFundoplication WrapObjective Structured Assessment

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