Fetal Endoscopic Surgery for Spina Bifida

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    50
  • sponsor
    Hospital Universitari Vall d'Hebron Research Institute
Updated on 21 January 2021
endoscopic surgery
prenatal
neural tube defect

Summary

This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.

Description

Introduction

Spina bifida is a congenital malformation characterized by a failure in neural tube closure. Unprotected fetal neural tissue at the spine level undergoes not only progressive neurodegeneration in spinal cord, but also the impairment in brain development, hindbrain herniation or Chiari II malformation probably due to pressure disturbances resulting from a continuous leakage of cerebrospinal fluid through the defect. The neurological consequences at birth are irreversible and sometimes devastating, including paraplegia, sphincter urinary and fecal incontinence, hydrocephalus, cranial nerve disturbances, respiratory problems and death due to spinal cord injury and brain maldevelopment.

Intrauterine fetal open repair of the defect has proved to improve hindbrain herniation and decrease the need of cerebrospinal shunting.

Hypothesis

The investigators hypothesize that minimally invasive surgery of spina bifida is feasible and may minimize surgical aggression and obstetrical complications, with similar neonatal and neurological results.

Intervention

In this study the investigators propose a fetoscopic skin closure technique. After a maternal laparotomy the uterus is exteriorized, the amniotic cavity is accessed by fetoscopic approach. The placode is dissected from the surrounding tissue and dropped into the opened spinal canal, untethered. Part of the cystic tissue is resected. The edges are then closed to the midline.

Follow up:

After surgery patients are followed up at the Fetal Medicine Unit every one or two weeks.

The mode of delivery is decided according to obstetric criteria. Neonates will be examined at birth, and followed up regularly at least until 30 months. Patients are lifetime followed up by our Multidisciplinary myelomeningocele (MMC) Committee that comprises professionals from the Spina Bifida Unit, Neonatologists, Pediatric Surgeons, Pediatric Urologist, Pediatric Orthopedic Surgeons, Radiologists, Rehabilitation, Pathologists, Pediatric Neurosurgeons, Obstetricians and Fetal Therapists.

Details
Condition Spina Bifida Cystica, Fetal disorder, Meningomyelocele, Hydrocephalus, CONGENITAL ANOMALY NOS, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Male Hormonal Deficiencies/Abnormalities, Birth Defects, Diastematomyelia, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Male Hormonal Deficiencies/Abnormalities, Chiari Malformation Type 2, Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus, Birth Defects, neural tube defect, ntds, neural tube defects, open spina bifida, myelomeningocele, Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus
Treatment Fetoscopic repair of spina bifida
Clinical Study IdentifierNCT03315637
SponsorHospital Universitari Vall d'Hebron Research Institute
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Maternal age > 18 years old
Singleton pregnancy
Gestational age between 18 0/7 weeks and 26 6/7 weeks
Isolated neural tube defect between T1 and S1
Cerebellar herniation (Chiari type II)

Exclusion Criteria

Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
Body mass index > 35 kg/m2
Maternal disorders contraindicating surgery
Genetic anomalies with poor prognosis
Sever kyphosis (>30)
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