Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique
研究概览
简要总结
Fetal spina bifida is a common birth defect that results in hydrocephalus, motor-, bowel-, bladder- and sexual dysfunction in the child. The condition is progressive in utero. Fetal surgery between 22-26 weeks gestation has been shown to stop the gradual fetal deterioration observed in this disease and improve infant outcomes. Children with spina bifida who have undergone fetal surgery have a lower need for hydrocephalus treatment (80%->40%) and twice the chance to walk independently by the age of 3 years (20%->40%). These benefits are also sustained in the longer term.
The traditional 'open' fetal surgical approach, however, as currently offered clinically at the Ontario Fetal Centre, comes with significant risks: it increases the risk of preterm birth, carries significant maternal morbidity and results in important uterine scarring. The latter comes with a risk of uterine rupture and fetal death both in the index pregnancy and future pregnancies.
To overcome these down sides of open fetal surgery, different centers have attempted a fetoscopic approach to the surgery. Fetoscopy indeed avoids uterine scarring and is likely protective against uterine rupture but is technically complex. This results in long surgical learning curves, poor dissemination of the surgery amongst centers worldwide, longer procedures and suboptimal surgical results which translate in decreased infant benefits - particularly with regards to motor function.
The investigators have developed a fetoscopic robotic approach where they leverage the dexterity of robotic instruments to perform these complex surgeries. The team expects that this will result in easier and faster procedures with better surgical outcomes and therefore fetal benefits comparable to open fetal surgery, while at the same time avoiding the need for hysterotomy.
In this prospective exploratory phase 1 study, the investigators propose to assess the feasibility of such a robotic approach, as developed and trained on a high-fidelity phantom, in 15 patients. The research team will collect maternal and fetal safety and efficacity data to inform later studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Isolated open fetal spina bifida
- •Healthy pregnant patient without risk factors for preterm delivery
- •Candidate for open fetal spina bifida surgery.
- •Maternal age 18 years or more and able to consent
- •Provision of written informed consent to participate in this study
- •Gestational age allowing for fetal surgery prior to 26 weeks gestation.
排除标准
- •Contraindication for surgery or safe anesthesia due to a severe maternal medical condition, including morbid obesity (BMI >40 kg/m2)
- •History of preterm birth, short cervical length, cervical cerclage
- •Placenta or vasa previa, invasive placentation
- •Inaccessibility of the uterus due to severe maternal obesity, uterine fibroids, bowel or placental superposition
- •Major fetal structural or genetic anomalies unrelated to spina bifida, requiring surgery or potentially leading to infant death or severe handicap
- •Neural tube defects other than open spina bifida
- •Absence of Chiari II malformation on ultrasound or MRI
- •Severe fetal kyphosis (>30 degrees)
- •Upper lesion level lower than sacral vertebra S
- •Multiple gestation
- •Fetal bleeding disorder (eg. Fetal/neonatal allo-immune thrombocytopenia)
- •Maternal infectious disorder which could result in materno-fetal transmission (eg HIV with high viral load)
结局指标
主要结局
Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique
时间窗: 1 hour postoperatively
Number of patients who underwent successful closure of the fetal spinal defect in layers using a laparotomy-assisted fetoscopic robotic technique without conversion to hysterotomy.
次要结局
- Number of patients with severe fetal complications(At delivery)
- Number of patients with severe maternal complications(At delivery)
- Number of patients experiencing preterm prelabor rupture of membranes(At delivery)
- Number of patients experiencing preterm birth(At delivery)
- Number of patients with a severe neonatal complication(At discharge from Neonatal Intensive Care Unit or 28 days of life whichever comes last)
- Number of infants requiring neonatal spinal scar revision(At 28 days of life)
- Number of infants with reversal of hindbrain herniation(At 28 days of life)
研究者
Tim Van Mieghem
Maternal-Fetal Medicine specialist, Clinician-Investigator
Mount Sinai Hospital, Canada