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cecam_trial

CECAM trial

Feasibility, safety, potential benefits and side effects of the fetoscopic treatment of open spina bifida using our unique surgical technique.

The study suggests that the antenatal treatment of open spina bifida (OSB) using a fetoscopic approach and a unique surgical technique can result in a watertight seal, reversal of the hindbrain herniation, and a better than expected motor function.

The technique differs substantially from the classic repair of OSB used in prior open fetal surgery and fetoscopic studies, in which the dura mater is dissected and the defect is closed in multiple layers. Instead, we use a biocellulose patch placed over the lesion and simple closure of the skin. As such, our technique is an alternative to the current paradigms in the antenatal treatment of OSB. Our clinical outcomes are in line with the results of our extensive prior animal work. Maternal benefits of our approach and technique include minimal morbidity and no myometrial legacy. Current limitations of the approach include potential loss of access, premature rupture of membranes and attendant prematurity. Phase II trials are needed to prevent these complications and to further assess the risks and benefits of our distinct surgical approach and technique 1).

1)
Pedreira DA, Zanon N, Nishikuni K, De Sá RA, Acacio GL, Chmait RH, Kontopoulos EV, Quintero RA. Endoscopic Surgery for the Antenatal Treatment of Myelomeningocele: The Cecam Trial. Am J Obstet Gynecol. 2015 Sep 16. pii: S0002-9378(15)01104-7. doi: 10.1016/j.ajog.2015.09.065. [Epub ahead of print] PubMed PMID: 26386383.
cecam_trial.txt · Last modified: 2015/09/22 09:00 (external edit)