NCT02390895

Prenatal Endoscopic Repair of Fetal Spina Bifida

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Myelomeningocele

Interventions

Type	Name	Description
PROCEDURE	endoscopic repair of myelomeningocele before 26 SA	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

Timeline

• Start date: 2017-05-17
• Primary completion: 2022-07-06
• Completion: 2022-07-06
• First posted: 2015-03-18
• Last updated: 2025-09-08

Locations

1 site across 1 country: France