口蓋裂の一次手術のタイミング Timing of Primary Surgery for Cleft Palate
Carrol Gamble,Christina Persson,Elisabeth Willadsen,Liz Albery,Helene Soegaard Andersen,Melissa Zattoni Antoneli,Malin Appelqvist,Ragnhild Aukner,Pia Bodling,Melanie Bowden,Karin Brunnegård,Gillian Cairns,Samantha Calladine,Linsay Campbell,Jill Clayton-Smith,Rachael Cooper,Elizabeth Conroy,Ahmed El-Angbawi,Berit Kildegaard Emborg,Josefin Enfält Wikman,Beth Fitzpatrick,Ana Paula Fukushiro,Cristina Guedes de Azevedo Bento Gonçalves,Christina Havstam,Anne Katherine Hvistendahl,Line Dahl Jorgensen,Kristina Klinto,Marit Berntsen Kvinnsland,Catriona Larham,Jorunn Lemvik,Louise Leturgie,Eva Liljerehn,Natalie Lodge,Anette Lohmander,Siobhan McMahon,Felicity Mehendale,Haline Coracine Miguel,Marianne Moe,Joan Bogh Nielsen,Jill Nyberg,Nina-Helen Pedersen,Ginette Phippen,Silvia Helena Alvarez Piazentin-Penna,Kathryn Patrick,Lindsay Pliskin,Lucy Rigby,Gunvor Semb,Lucy Southby,Maria Sporre,Ann-Sofie Björkman Taleman,Jorid Tangstad,Inge Elly Kiemle Trindade,Imogen Underwood,Stephanie van Eeden,Liisi Raud Westberg,Paula Ruth Williamson,Renata Paciello Yamashita,Kevin Munro,Tanya Walsh,and William Shaw,for the TOPS Study Group
New England Journal of Medicine Published:August 31, 2023
Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown.
We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth.
We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P=0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up.
Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551. opens in new tab.)