Anette Lohmander1, Christina Persson2, Elisabeth Willadsen3, Inger Lundeborg4, Suvi Alaluusua5, Ragnhild Aukner6, Anja Bau7, Maria Boers7, Melanie Bowden8, Julie Davies8, Berit Emborg9, Christina Havstam10, Christine Hayden11, Gunilla Henningsson12, Anders Holmefjord13, Elina Hölttä5, Mia Kisling-Møller9, Lillian Kjøll6, Maria Lundberg12, Eilish McAleer11, Jill Nyberg12, Marjukka Paaso5, Nina Helen Pedersen13, Therese Rasmussen13, Sigvor Reisæter13, Helene Søgaard Andersen7, Antje Schöps7, Inger-Beate Tørdal6, Gunvor Semb6,14,15. 1. a Division of Speech and Language Pathology , Karolinska Institutet, and Karolinska University Hospital , Stockholm , Sweden. 2. b Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Division of Speech and Language Pathology , Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital , Gothenburg , Sweden. 3. c Department of Nordic Studies and Linguistics , University of Copenhagen , Denmark. 4. d Division of Speech and Language Pathology , Linköping University , Linköping , Sweden. 5. e Cleft Palate and Craniofacial Center , Helsinki University Central Hospital , Finland. 6. f Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway. 7. g Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark. 8. h Department of Plastic Surgery, Greater Manchester Cleft Unit , Royal Manchester Children's Hospital , Manchester , UK. 9. i Cleft Palate Center , Aarhus , Denmark. 10. j Division of Speech and Language Pathology , Sahlgrenska University Hospital , Gothenburg , Sweden. 11. k The Royal Hospital for Sick Children , Belfast , Northern Ireland. 12. l Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden. 13. m Statped Vest , Bergen , Norway. 14. n School of Dentistry , University of Manchester , Manchester , UK. 15. o Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
Abstract
BACKGROUND AND AIM: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with a non-syndromic UCLP. Speech audio and video recordings of 391 children (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments. RESULTS: There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%. CONCLUSIONS: No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed. TRIAL REGISTRATION: ISRCTN29932826.
BACKGROUND AND AIM: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with a non-syndromic UCLP. Speech audio and video recordings of 391 children (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments. RESULTS: There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%. CONCLUSIONS: No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed. TRIAL REGISTRATION: ISRCTN29932826.
Authors: Elizabeth J Conroy; Rachael Cooper; William Shaw; Christina Persson; Elisabeth Willadsen; Kevin J Munro; Paula R Williamson; Gunvor Semb; Tanya Walsh; Carrol Gamble Journal: Trials Date: 2021-01-04 Impact factor: 2.279
Authors: Hilary McCrary; Sarah Hatch Pollard; Vanessa Torrecillas; Leon Khong; Helene M Taylor; Jeremy Meier; Harlan Muntz; Jonathan Skirko Journal: Cleft Palate Craniofac J Date: 2020-03-24