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Timing of Primary Surgery for Cleft Palate
Carrol Gamble1, Christina Persson1, Elisabeth Willadsen1
1From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and Leeds General Infirmary (C.L.), Leeds, Cleft Care Scotland, Glasgow (L.C.), Bristol Dental Hospital, Bristol (L.A.), the University of Manchester (J.C.-S., A.E.-A., G.S., K.M., T.W., W.S.) and Manchester University NHS Foundation Trust (M.B., K.P.), Manchester, Birmingham Children's Hospital (B.F.) and Birmingham Women's and Children's NHS Foundation Trust (I.U.), Birmingham, Salisbury District Hospital, Salisbury (G.P.), Royal Victoria Infirmary, Newcastle upon Tyne (L.R., S.E.), and Oxford University Hospitals NHS Foundation Trust, Oxford (L.S.) - all in the United Kingdom; the University of Gothenburg (C.P.) and Sahlgrenska University Hospital (C.H.), Gothenburg, Uppsala University Hospital, Uppsala (M.A., E.L.), Linköping University Hospital, Linköping (P.B., A.-S.B.T.), Umeå University (K.B.) and Norrlands University Hospital (J.E.W.), Umeå, Skåne University Hospital, Malmö (K.K., M.S.), Karolinska Institutet, Solna (A.L., J.N.), and Karolinska University Hospital, Stockholm (L.R.W.) - all in Sweden; the University of Copenhagen (E.W., L.D.J.) and Copenhagen Cleft Palate Center (H.S.A., L.D.J.), Copenhagen, and the Cleft Palate Center, Aarhus (B.K.E., L.L., J.B.N.) - all in Denmark; the University of São Paulo, Bauru, Brazil (M.Z.A., A.P.F., C.G.A.B.G., H.C.M., S.H.A.P.-P., I.E.K.T., R.P.Y.); and Statped (R.A., A.K.H., M.B.K., J.L.) and Statped Sørøst (M.M.), Oslo, and Statped Vest, Bergen (N.-H.P., J.T.) - all in Norway.
Insights
Early cleft palate surgery at 6 months significantly reduces velopharyngeal insufficiency by age 5 compared to 12 months. This benefits speech outcomes in infants with isolated cleft palate.
Area of Science:
- Craniofacial Surgery
- Pediatric Otolaryngology
- Speech-Language Pathology
Background:
- The optimal timing for primary surgery in infants with isolated cleft palate remains unclear regarding long-term outcomes.
- Key areas of investigation include speech, hearing, dentofacial development, and patient safety.
Purpose of the Study:
- To compare the efficacy of primary cleft palate surgery at 6 months versus 12 months of age.
- To evaluate the impact of surgical timing on velopharyngeal function, speech development, hearing, and dentofacial outcomes.
Main Methods:
- A randomized controlled trial assigned 558 infants with nonsyndromic isolated cleft palate to surgery at 6 or 12 months.
- Speech and language therapists assessed velopharyngeal function via standardized recordings at 5 years of age.
- Primary outcome: velopharyngeal insufficiency (VPI) score ≥4 at age 5; secondary outcomes included speech, hearing, dentofacial development, and complications.
Main Results:
- Fewer infants in the 6-month group (8.9%) experienced VPI at age 5 compared to the 12-month group (15.0%), a statistically significant difference (RR 0.59, P=0.04).
- Postoperative complications and serious adverse events were infrequent and comparable between the two groups.
- Speech recordings were analyzed from 83.6% of the 6-month group and 81.6% of the 12-month group.
Conclusions:
- Primary cleft palate surgery at 6 months of age leads to a lower incidence of velopharyngeal insufficiency at 5 years compared to surgery at 12 months.
- This earlier surgical timing appears beneficial for speech outcomes in infants with isolated cleft palate.
- The study was conducted in well-resourced settings and funded by the National Institute of Dental and Craniofacial Research.
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
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.).
