Validation of a high-fidelity training model for fetoscopic spina bifida surgery.

Open fetal surgery for spina bifida (SB) is safe and effective yet invasive. The growing interest in fetoscopic SB repair (fSB-repair) prompts the need for appropriate training. We aimed to develop and validate a high-fidelity training model for fSB-repair. fSB-repair was simulated in the abdominal cavity and on the stomach of adult rabbits. Laparoscopic fetal surgeons served either as novices (n = 2) or experts (n = 3) based on their experience. Technical performance was evaluated using competency Cumulative Sum (CUSUM) analysis and the group splitting method. Main outcome measure for CUSUM competency was a composite binary outcome for surgical success, i.e. watertight repair, operation time ≤ 180 min and Objective-Structured-Assessment-of-Technical-Skills (OSATS) score ≥ 18/25. Construct validity was first confirmed since competency levels of novices and experts during their six first cases using both methods were significantly different. Criterion validity was also established as 33 consecutive procedures were needed for novices to reach competency using learning curve CUSUM, which is a number comparable to that of clinical fSB-repair. Finally, we surveyed expert fetal surgeons worldwide to assess face and content validity. Respondents (26/49; 53%) confirmed it with ≥ 71% of scores for overall realism ≥ 4/7 and usefulness ≥ 3/5. We propose to use our high-fidelity model to determine and shorten the learning curve of laparoscopic fetal surgeons and retain operative skills.

Fetal Tracheal Occlusion for Severe Pulmonary Hypoplasia in Isolated Congenital Diaphragmatic Hernia: A Systematic Review and Meta-analysis of Survival.

OBJECTIVE: To evaluate fetal survival after tracheal occlusion in fetuses with severe pulmonary hypoplasia and isolated congenital diaphragmatic hernia (CDH). BACKGROUND: Despite recent advances in neonatal intensive care, CDH still has a high mortality and morbidity. Fetoscopic endoluminal tracheal occlusion (FETO) stimulates lung growth and improves gas exchange in animal models of CDH, but the effects in humans are still under investigation. METHODS: We searched Pubmed, Cochrane, EMBASE, and Scopus databases for clinical studies on tracheal occlusion and CDH. All studies comparing FETO and a contemporary control group were included. The primary outcome was survival, with the need for oxygen on discharge the secondary outcome. Meta-analysis of outcome measures was performed and odds ratios, relative risk ratios, and 95% confidence intervals were estimated with a fixed-effects model and were reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. RESULTS: Between 1997 and 2015, five eligible studies describing 211 patients were included (101 control and 110 FETO). All studies selected isolated severe CDH fetuses with a lung-to-head ratio 1.0 or less and liver herniation into the thoracic cavity. FETO favored survival outcome (odds ratio 13.32; 95% confidence interval, 5.40-32.87). Meta-analysis of the secondary outcome oxygen need at discharge could not be calculated, because it was not reported in all included studies. CONCLUSIONS: FETO improves survival in isolated CDH with severe pulmonary hypoplasia compared with the standard perinatal management.

The role of screening audiometry in the management of otitis media with effusion in children with cleft palate in northern ireland.

OBJECTIVE: To determine uptake and outcome of hearing screening in the cleft palate population in Northern Ireland (NI) and the rate of ventilation tube (VT) insertion over a 3-year period. DESIGN: In NI, hearing screening is offered in the neonatal period, at 9 months in the community, and at 2.5 years in the joint cleft clinic. Patients : Eighty-five children with cleft palate born between 2006 and 2008 in NI were eligible for all three screenings. METHODS: A retrospective case note review was performed of tympanograms, audiometry, and VT insertion rates at each of the three time points. Results : In the neonatal period, all patients eligible were screened; 66 (77.6%) patients passed the screening, with 19 patients (22.4%) failing, resulting in direct referral to ENT for consideration of VT. Results of the 9-month community screening were not made routinely available to the regional cleft service. At the 2.5-year clinic screening, all attending patients (n = 80) had documented screening. Fifty-two (65%) patients passed screening, with 28 patients (35%) failing screening. Forty-six patients (57.5%) had documented VT, and 9 (11.25%) were awaiting ENT review for consideration of VT. CONCLUSION: Ventilation tubes are not routinely inserted at the time of cleft repair in the NI population, and 57.5% of our cleft population has ventilation tubes inserted by 2.5 years. Cleft patients in NI have regular routine hearing assessments, and our current practice avoids universal ventilation tube insertion while identifying those who need further hearing management. Further research is needed to reach an international consensus on the insertion of VT in cleft patients.