02.03 PLA/PCL patch assessment for prenatal MMC repair using a fetoscopic surgical simulator

J. Peiro1, M. Miyabe1, S. Duru1, J. Hawes2, C. Lin2, M. Oria1  1Cincinnati Children’s Hospital Medical Center, Pediatric Surgery, Cincinnati, OH, USA 2University Of Cincinnati, Orthopaedic Surgery, Cincinnati, OH, USA

Introduction: The objective of this study was to compare the surgical functionality for duraplasty between our new designed PLA/PCL “smart patch” and another one, as the cryopreserved human umbilical-cord (HUC) matrix, in the fetoscopic myelomeningocele repair by using a fetoscopic surgical simulator.

Methods: A fetoscopic box trainer with inanimate silicone fetus doll, previously used in our laboratory for surgical simulation for training our learning curve and compare 2D and 3D scopes (Patel, 2020), was used to compare the performance of PLA/PCL vs HUC patch during prenatal myelomeningocele repair. The silicon doll was wrapped with chicken skin to simulate a lumbar defect. Participants with varying surgical experience were divided in three groups considering their laparoscopic knowledge (novice, intermediate and expert) and were asked to complete four tasks: patch introduction thru-trocar, manipulation placement of the patch subcutaneously, and skin closure. All completed the four tasks using both patches randomized in different days. Time to completion was measured, and the participants subsequently completed the NASA Load Index test and questionnaires evaluating their experiences. 

Results: Twenty participants completed the tasks twice. Eight were classified as novice (40%), 4 as intermediate (20%) and 8 as experts (40%). The “patch introduction” task was faster with PLA/PCL patch in all groups but with statistical significance in the “novice” group with 16.88 seconds for PLA/PCL vs 39.50 seconds for the amniotic membrane (p=0.010) and the ‘experts” group with 11.4 seconds for the PLA/PCL vs 23.9 seconds for the amniotic membrane group (p=0.019). For the other three tasks there was no statistically significant differences. 19/20 participants (95%) referred subjective preference for the PLA/PCL patch.

Conclusion: Smart PLA/PCL patch with its preformed coiled tube shape and self-expandable property by body-temperature activation facilitates its introduction thru the trocar compared to the HUC patch. The similar functionality in the other tasks shows that the smart PLA/PCL patch is a great candidate as dural substitute in fetoscopic myelomeningocele repair.