Hôpital Necker Enfants Malades
Paris, 75015, France
NCT Number: NCT02390895
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
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Notify Me18 year and older
Female
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Before 26 gestational weeks
Composite criteria:
Time frame: Day 0 (birth of neonates)
Need for neonatal surgery
Time frame: Day 0 (birth of neonates)
the existence of an Arnold Chiari anomaly at birth
Time frame: Within the 6 months after birth
Ventriculo-peritoneal shunt within the 6 months after birth
Time frame: Within the 6 months after birth
Time frame: From surgery to delivery
Composite criteria:
Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events
Time frame: Within the 6 months after birth
Time frame: From surgery to delivery
Composite criteria:
Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events
Time frame: Within the 12 months after birth
Composite criteria:
Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ENDOSPIN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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