Ueli Möhrlen1,2,3, Nicole Ochsenbein-Kölble2,4, Luca Mazzone1,2,3, Franziska Kraehenmann2,4, Margaret Hüsler2,4, Barbara Casanova1,2,3, Peter Biro1,5, David Wille6,3, Bea Latal7,3, Ianina Scheer2,8,3, Vera Bernet9,3, Theres Moehrlen1,2,3, Leonhard Held10, Alan W Flake11, Roland Zimmermann2,4, Martin Meuli12,13,14. 1. Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland. 2. The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland. 3. Children's Research Center, University Children's Hospital of Zurich, University of Zurich, Zurich, Switzerland. 4. Department of Obstetrics, University Hospital Zurich, Zurich, Switzerland. 5. Institute of Anaesthesiology, University Hospital Zurich, Zurich, Switzerland. 6. Department of Pediatric Neurology, University Children's Hospital Zurich, Zurich, Switzerland. 7. Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland. 8. Department of Diagnostic Imaging, MR-Center, University Children's Hospital Zurich, Zurich, Switzerland. 9. Department of Intensive Care and Neonatology, University Children's Hospital Zurich, Zurich, Switzerland. 10. Department of Biostatistics, Institute for Epidemiology, Biostatistics and Prevention, University of Zurich, Zurich, Switzerland. 11. The Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. 12. Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland, martin.meuli@kispi.uzh.ch. 13. The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland, martin.meuli@kispi.uzh.ch. 14. Children's Research Center, University Children's Hospital of Zurich, University of Zurich, Zurich, Switzerland, martin.meuli@kispi.uzh.ch.
Abstract
INTRODUCTION: The Management of Myelomeningocele Study, a.k.a. the MOMS trial, was published in 2011 in the New England Journal of Medicine. This prospective randomized controlled trial proved to be a milestone publication that provided definitive evidence that fetal surgery is a novel standard of care for select fetuses with spina bifida aperta (SB). The goal of our study is to assess whether our center can match these benchmark results. MATERIALS AND METHODS: Our study was conducted according to the MOMS protocol using the same inclusion and exclusion criteria and looked at the same outcome parameters that were used in the MOMS trial. Zurich and MOMS results were compared. RESULTS:We enrolled 20 patients between December 2010 and May 2015 all of whom underwent fetal surgery for SB. Among 51 different outcome variables, there were only 3 favorable (multiplicity-adjusted) significant differences (gestational age at birth, hindbrain herniation, and psychomotor development). There were no statistically significant differences regarding any other parameters. CONCLUSION: Our findings confirm that rigorous apprenticeship, training, and comprehensive prospective data collection enable centers like the Zurich Center for Fetal Diagnosis and Therapy to achieve benchmark results for open fetal surgery for myelomeningocele and myeloschisis. These results justify the existence and continuation of our program. Outcome documentation is an essential element of quality management. It is medically and ethically fundamental for fetal medicine and surgery centers offering high-end innovative medical care.
RCT Entities:
INTRODUCTION: The Management of Myelomeningocele Study, a.k.a. the MOMS trial, was published in 2011 in the New England Journal of Medicine. This prospective randomized controlled trial proved to be a milestone publication that provided definitive evidence that fetal surgery is a novel standard of care for select fetuses with spina bifida aperta (SB). The goal of our study is to assess whether our center can match these benchmark results. MATERIALS AND METHODS: Our study was conducted according to the MOMS protocol using the same inclusion and exclusion criteria and looked at the same outcome parameters that were used in the MOMS trial. Zurich and MOMS results were compared. RESULTS: We enrolled 20 patients between December 2010 and May 2015 all of whom underwent fetal surgery for SB. Among 51 different outcome variables, there were only 3 favorable (multiplicity-adjusted) significant differences (gestational age at birth, hindbrain herniation, and psychomotor development). There were no statistically significant differences regarding any other parameters. CONCLUSION: Our findings confirm that rigorous apprenticeship, training, and comprehensive prospective data collection enable centers like the Zurich Center for Fetal Diagnosis and Therapy to achieve benchmark results for open fetal surgery for myelomeningocele and myeloschisis. These results justify the existence and continuation of our program. Outcome documentation is an essential element of quality management. It is medically and ethically fundamental for fetal medicine and surgery centers offering high-end innovative medical care.
Authors: Katarzyna Michalak-Micka; Dominic Rütsche; Luca Mazzone; Vanessa L Büchler; Ueli Moehrlen; Agnes S Klar; Thomas Biedermann Journal: Front Bioeng Biotechnol Date: 2022-09-15
Authors: Zehra S Hepp; Verena M Haas; Beatrice Latal; Martin Meuli; Ueli Möhrlen; Sonja M Schauer; Robert Steinfeld; Beth A Padden; David A Wille Journal: Dev Med Child Neurol Date: 2021-07-23 Impact factor: 5.449