Fetal Endoscopic Surgery for Spina Bifida

Not Applicable

Recruiting

• Conditions: Neural Tube Defects; Hydrocephalus; Congenital Abnormality; Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus; Spina Bifida, Open; Myelomeningocele; Fetal Disease; Chiari Malformation Type 2
• Interventions: Procedure: Fetoscopic repair of spina bifida

• Registration Number: NCT03315637
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed 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 Timeline

• Study Start: 2015-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-16
• Last Update Submitted: 2017-10-16
• Study First Posted: 2017-10-20
• Last Update Posted: 2017-10-20
• Primary Completion: 2021-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 (>30º)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fetoscopic repair of spina bifida	Fetoscopic repair of spina bifida	This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida

Primary Outcome Measures

Name	Time	Method
Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)	Time of procedure (day 0)	Binary variable (yes/no) describing if the neural tube defect has been successfully closed, (placode dissected and dropped into the open spinal canal, cystic tissue resected and edges closed to the midline), by fetoscopic surgery, and without conversion to open surgery

Secondary Outcome Measures

Name	Time	Method
Operating time (minutes)	Time of procedure (day 0)	Time between the skin opening and skin closure
Fetoscopy time (minutes)	Time of procedure (day 0)	Time between the introduction of the first cannula and the removal of the last cannula
Hospital stay (days)	Between procedure and delivery, up to 21 weeks	Time between hospital admission and discharge

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain