Work

PLA/PLC “Smart Patch” functionality assessment for fetal duraplasty in prenatal myelomeningocele repair using a fetoscopic surgical simulator

Year: 2026

Type: article

Abstract: BACKGROUND: Fetoscopy has emerged as a minimally invasive alternative to open hysterotomy for prenatal repair of myelomeningocele (MMC), which often requires a dural substitute. Our team developed a novel PLA/PCL patch optimized for fetoscopic surgery. This study compared the performance of the PLA/PCL patch with a human umbilical cord (HUC) graft. METHODS: Twenty-seven medical professionals with varied experience performed four MMC repair tasks in a fetoscopic simulator: patch introduction, manipulation, placement, and suture. In a randomized crossover design, each participant performed the tasks twice, once with each graft. Task times were recorded. After each attempt, participants completed task-specific difficulty questionnaires and the NASA Task Load Index (NASA-TLX); after both attempts, they completed a comparative questionnaire assessing overall preference and perceived performance. RESULTS: Participants included nine experts, nine intermediates, and nine novices. Introduction was significantly faster with PLA/PCL across all experience levels and overall (16 ± 7 s vs 35 ± 17 s, p < 0.001). Manipulation was also shorter with PLA/PCL (50 ± 29 s vs 69 ± 36 s, p = 0.05), whereas placement was longer (79 ± 71 s vs 43 ± 23 s, p = 0.017). Suturing time and total procedural time did not differ between grafts. NASA-TLX scores showed lower physical demand (p = 0.003) and effort (p = 0.018) with PLA/PCL. The pre-folded design was rated highly useful (mean=9.1/10), with minimal unfolding difficulty (mean = 2.1/10). Most participants found PLA/PCL easier for introduction (85%), manipulation (81%), placement (78%), and suturing (85%). CONCLUSION: The PLA/PCL patch is a promising dural substitute for prenatal MMC repair. Its shape-memory design enabled faster introduction and manipulation and reduced perceived workload compared with HUC, while maintaining comparable total procedural times. These findings support further preclinical evaluation of this novel graft.

Source: Surgical Endoscopy

DOI: 10.1007/s00464-026-13517-7