3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 5 systematic reviews and meta-analysis, 1 randomised controlled trial, 3 case series and 1 case report. It is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes in the baby to be: motor function, hind brain herniation, hydrocephalus, bowel and bladder function, and need for further surgery.
3.3 The specialist advisers and the committee considered the key safety outcomes in the baby to be: fetal mortality, perinatal death, premature birth, premature rupture of membranes, cerebrospinal fluid leakage and the potential for late spinal cord complications including tethered spinal cord and syringomyelia. Key safety outcomes for the mother are: operative morbidity, incisional hernia, uterine dehiscence or rupture in the current or subsequent pregnancy, and morbidly adherent placenta in subsequent pregnancies.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted the need to identify the risks and benefits for both the fetus and mother (including her subsequent pregnancies) including long-term outcomes, and that these need to be discussed during parental counselling by the multidisciplinary team.
3.6 The committee noted that some of the data it considered was for operations done at a gestational age above 26 weeks.
3.7 This guidance requires that clinicians doing the procedure make special arrangements for audit. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).