Fetal Endoscopic Surgery for Spina Bifida

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Arnold-Chiari Malformation
Chiari Malformation Type 2
Congenital Abnormalities
Congenital Abnormality
Fetal Disease
Hydrocephalus
Meningomyelocele
Myelomeningocele
Neural Tube Defects
Spina Bifida, Open
Spinal Dysraphism
Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

Clinical Trial Details

NCT number	NCT03315637
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact	Elena Carreras, PhD
Email	ecarreras@vhebron.net
Status	Recruiting
Phase	N/A
Start date	January 2015
Completion date	December 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fetal Endoscopic Surgery for Spina Bifida — FESSB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms