Fetoscopic Robotic Open Spina Bifida Treatment

Официальное название

Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study

Обзор

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.

Вмешательства

• Процедура Fetoscopic robotic open spina bifida closure
  Three 9 mm laparoscopic trocars will be inserted into the uterus after the uterus is exteriorized through a maternal laparotomy. Partial amniotic carbon dioxide insufflation will be done with heated humidified gas. Using a surgical robot, multilayer closure of the lesion will be performed, similar to our current protocol in open fetal spina bifida closure (durapatch, myofascial flap, skin closure). Pre- and postoperative management will be similar to our current open fetal surgery protocol. Del

Первичные конечные точки

• Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique [Срок оценки: 1 hour postoperatively]

Вторичные конечные точки (7)

• Number of patients with severe fetal complications [Срок оценки: At delivery]
• Number of patients with severe maternal complications [Срок оценки: At delivery]
• Number of patients experiencing preterm prelabor rupture of membranes [Срок оценки: At delivery]
• Number of patients experiencing preterm birth [Срок оценки: At delivery]
• Number of patients with a severe neonatal complication [Срок оценки: At discharge from Neonatal Intensive Care Unit or 28 days of life whichever comes last]
• Number of infants requiring neonatal spinal scar revision [Срок оценки: At 28 days of life]
• Number of infants with reversal of hindbrain herniation [Срок оценки: At 28 days of life]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 S1.
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06907732 · FROST001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗