The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch
Compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. This study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial. Technically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. The defect will be dissected and the cord replaced in the canal. Closure will be performed by suturing paravertebral muscles using a barbed running suture. A Duragen patch will be sutured when primary closure is deemed impossible.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
prenatal minimally-invasive fetoscopic closure with iii) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation iv) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch
Hôpital Necker Enfants Malades
Paris, France
Successful surgery
Composite criteria: 1. dissection of the placode 2. primary coverage or use of a patch 3. using only endoscopy with two trocars
Time frame: Before 26 gestational weeks
Neonatal surgery
Need for neonatal surgery
Time frame: Day 0 (birth of neonates)
Arnold Chiari anomaly at birth
the existence of an Arnold Chiari anomaly at birth
Time frame: Day 0 (birth of neonates)
Ventriculo-peritoneal shunt
Ventriculo-peritoneal shunt within the 6 months after birth
Time frame: Within the 6 months after birth
Level of injury
Time frame: Within the 6 months after birth
Foetal morbidity
Composite criteria: Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events
Time frame: From surgery to delivery
Motor lower limb improvement outcomes
Time frame: Within the 6 months after birth
Maternal morbidity
Composite criteria: Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events
Time frame: From surgery to delivery
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Neurological development
Composite criteria: Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter
Time frame: Within the 12 months after birth