loading page

Fetoscopic Robotic Open Spina bifida Treatment (FROST): feasibility and learning curve study in a preclinical representative training model
  • +6
  • 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
Author Profile
Charlotte C. KIK
Erasmus MC
Author Profile
Francis LEBOUTHILLIER
Ontario College of Art and Design University
Author Profile
Nimrah Abbasi
Mount Sinai Hospital
Author Profile
Greg Ryan
Mount Sinai Hospital
Author Profile
Jochem Spoor
Erasmus MC
Author Profile
Thomas LOOI
Hospital for Sick Children
Author Profile
Abhaya V. KULKARNI
Ontario Fetal Centre
Author Profile
Tim Van Mieghem
Mount Sinai Hospital

Corresponding Author:[email protected]

Author Profile

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