ENDOSPIN: Prenatal Endoscopic Repair of Fetal Spina Bifida
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Minimally-invasive endoscopic repair endoscopic repair of myelomeningocele before 26 SA |
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
|
Outcome Measures
Primary Outcome Measures
- Successful surgery [Before 26 gestational weeks]
Composite criteria: dissection of the placode primary coverage or use of a patch using only endoscopy with two trocars
- Neonatal surgery [Day 0 (birth of neonates)]
Need for neonatal surgery
- Arnold Chiari anomaly at birth [Day 0 (birth of neonates)]
the existence of an Arnold Chiari anomaly at birth
- Ventriculo-peritoneal shunt [Within the 6 months after birth]
Ventriculo-peritoneal shunt within the 6 months after birth
- Level of injury [Within the 6 months after birth]
- Foetal morbidity [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
- Motor lower limb improvement outcomes [Within the 6 months after birth]
- Maternal morbidity [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
Secondary Outcome Measures
- Neurological development [Within the 12 months after birth]
Composite criteria: Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient > 18 years old, with an assumption by health insurance, understanding and speaking French
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A term < or = 26 +0 weeks gestational age
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Single-Pregnancy
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Myelomeningocele with higher-level defect between S1 and T1
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Arnold Chiari anomaly
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No associated anomaly or chromosic anomaly
Exclusion Criteria:
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severe foetal kyphoscoliosis associated
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Increased risk of preterm birth: cervical length <15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane
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placenta previa, accreta or placental abruption
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Maternal obesity with BMI> 35
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Uterine anomalies : large interstitial uterine fibroid, uterine malformation
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maternal infection with a foetal transmission risk: HIV, HBV, HCV
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Maternal contradiction in surgery or anesthesia
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poor social status and/or social isolation
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impossible post-surgery follow-up
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want to have a medical pregnancy termination
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Necker Enfants Malades | Paris | France | 75015 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Yves Ville, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Study Director: Julien Stirnemann, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
- Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.
- Degenhardt J, Schürg R, Winarno A, Oehmke F, Khaleeva A, Kawecki A, Enzensberger C, Tinneberg HR, Faas D, Ehrhardt H, Axt-Fliedner R, Kohl T. Percutaneous minimal-access fetoscopic surgery for spina bifida aperta. Part II: maternal management and outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):525-31. doi: 10.1002/uog.13389.
- Kohl T. Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part I: surgical technique and perioperative outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):515-24. doi: 10.1002/uog.13430.
- Verbeek RJ, Heep A, Maurits NM, Cremer R, Hoving EW, Brouwer OF, van der Hoeven JH, Sival DA. Fetal endoscopic myelomeningocele closure preserves segmental neurological function. Dev Med Child Neurol. 2012 Jan;54(1):15-22. doi: 10.1111/j.1469-8749.2011.04148.x. Epub 2011 Nov 29. Review.
- P141202
- 2014-A01948-39