Kunpalin Yada, Kik Charlotte C, Lebouthillier Francis, Abbasi Nimrah, Ryan Greg, Spoor Jochem, Looi Thomas, Kulkarni Abhaya V, Van Mieghem Tim
Fetal Medicine Unit, Department of Obstetrics & Gynaecology, Mount Sinai Hospital and University of Toronto, Toronto, Canada.
Department of Neurosurgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
BJOG. 2025 Aug;132(9):1259-1268. doi: 10.1111/1471-0528.18161. Epub 2025 Apr 3.
The primary aim was to assess the feasibility of robotic OSB repair in a simulation training model, documenting the learning curve and ensuring quality control among surgeons.
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.
The simulator was created through 3D printing and hand sculpting, simulating a partially exteriorised uterus for laparotomy-assisted laparoscopic OSB surgery. It included a silicone uterus, placenta and foetal manikin with a simulated OSB lesion, replicating the lesion sac, paraspinal muscles and neural placode.
Four surgeons participated: an expert Maternal Fetal Medicine consultant, a neurosurgical consultant, a Maternal Fetal Medicine fellow and a neurosurgical resident.
The surgical procedure included eight steps: uterine access, working space creation, lesion exposition, junctional zone dissection, skin mobilisation, dural patch application, closure of myofascial flaps and closure of skin. Success was defined by precise restoration (suture interval < 3 mm), foetal repair time ≤ 120 min and a GEARS score > 21/30.
Learning curve and competency were documented via LC-CUSUM and C-CUSUM.
Competence was achieved after 15-21 procedures, with novices reaching competency within this range. Participants maintained high performance in subsequent quality-controlled procedures.
Robotic-assisted foetal OSB surgery in a high-fidelity simulation is feasible, showing promising outcomes for a large animal model and clinical translation.
主要目的是在模拟训练模型中评估机器人开放性脊柱裂修复术的可行性，记录学习曲线并确保外科医生之间的质量控制。
使用累积求和检验（LC-CUSUM）评估学习曲线。在LC-CUSUM之后，进行了另外六项实验以进行能力累积求和（C-CUSUM）分析，以确保持续的质量控制。
模拟器通过3D打印和手工雕刻创建，模拟用于剖腹术辅助腹腔镜开放性脊柱裂手术的部分外露子宫。它包括一个硅胶子宫、胎盘和带有模拟开放性脊柱裂病变的胎儿模型，复制病变囊、椎旁肌和神经基板。
四名外科医生参与：一位母胎医学专家顾问、一位神经外科顾问、一位母胎医学研究员和一位神经外科住院医师。
手术过程包括八个步骤：子宫入路、创造工作空间、暴露病变、分离交界区、游离皮肤、应用硬脑膜补片、关闭肌筋膜瓣和关闭皮肤。成功的定义为精确修复（缝合间距<3毫米）、胎儿修复时间≤120分钟且GEARS评分>21/30。
通过LC-CUSUM和C-CUSUM记录学习曲线和能力。
在进行15 - 21次手术后达到了能力要求，新手在此范围内达到了能力要求。参与者在随后的质量控制程序中保持了高性能。
在高保真模拟中进行机器人辅助胎儿开放性脊柱裂手术是可行的，对大型动物模型和临床转化显示出有前景的结果。
