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Fetoscopic Robotic Open Spina bifida Treatment (FROST): feasibility and learning curve study in a preclinical representative training model
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  • Yada Kunpalin,
  • Charlotte C. KIK,
  • Francis LEBOUTHILLIER,
  • Nimrah Abbasi,
  • Greg Ryan,
  • Jochem Spoor,
  • Thomas LOOI,
  • Abhaya V. KULKARNI,
  • Tim Van Mieghem
Yada Kunpalin
Mount Sinai Hospital
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Charlotte C. KIK
Erasmus MC
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Francis LEBOUTHILLIER
Ontario College of Art and Design University
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Nimrah Abbasi
Mount Sinai Hospital
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Greg Ryan
Mount Sinai Hospital
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Jochem Spoor
Erasmus MC
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Thomas LOOI
Hospital for Sick Children
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Abhaya V. KULKARNI
Ontario Fetal Centre
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Tim Van Mieghem
Mount Sinai Hospital

Corresponding Author:tim.vanmieghem@sinaihealth.ca

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Abstract

Objective: The primary aim was to assess the feasibility of robotic OSB repair in a preclinical high-fidelity training model, documenting the learning curve and ensuring quality control among surgeons. Design: The learning curve was assessed using the cumulative summation test (LC-CUSUM). Following LC-CUSUM, six additional experiments were performed for competency-cumulative summation (C-CUSUM) analysis to ensure ongoing quality control. Setting: The simulator was created through 3D printing and hand sculpting, simulating a partially exteriorized uterus for laparotomy-assisted laparoscopic OSB surgery. It included a silicone uterus, placenta, and fetal manikin with a simulated OSB lesion, replicating the lesion sac, paraspinal muscles, and neural placode. Population: Four surgeons participated: an expert MFM consultant (TVM), a neurosurgical consultant (AK), an MFM fellow (novice 1, YK), and a neurosurgical resident (novice 2, CK). Methods: The surgical procedure included 8 steps: uterine access, working space creation, lesion exposition, junctional zone dissection, skin mobilization, dural patch application, and closure of myofascial flaps and skin. Success was defined by precise restoration (suture interval <3mm), total operative time ≤180 minutes, and a GEARS score >21/30. Main outcomes: Learning curve and competency were documented via LC-CUSUM and C-CUSUM. Results: Competence was achieved after 15–21 procedures, with novices reaching competency within this range. Participants maintained high performance in subsequent quality-controlled procedures. Conclusion: Robotic-assisted fetal OSB surgery in a high-fidelity simulation is feasible, showing promising outcomes for a large animal model and clinical translation .
17 Nov 2024Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
28 Nov 2024Submission Checks Completed
28 Nov 2024Assigned to Editor
28 Nov 2024Review(s) Completed, Editorial Evaluation Pending
02 Dec 2024Reviewer(s) Assigned