Timing of Primary Surgery for Cleft Palate

Infographic · Nov 2023 · 2 min read

In brief

Randomized trial of 558 infants found that primary cleft palate repair at 6 months resulted in significantly lower rates of velopharyngeal insufficiency at age 5 compared to repair at 12 months (8.9% vs 15.0%). Earlier surgery showed similar safety profiles with better long-term speech outcomes.

Primary cleft palate repair at 6 months reduces velopharyngeal insufficiency at age 5 compared to 12-month surgery (8.9% vs 15.0%, P=0.04)
Earlier surgery (6 months) shows 41% lower risk of speech problems without increased postoperative complications in adequately resourced centers
Standardized surgical technique across 23 European and South American centers demonstrated safety and feasibility of 6-month repair timing
Velopharyngeal function outcomes favor earlier intervention, challenging traditional 12-month timing for isolated cleft palate repair
Serious adverse events were rare (4 total cases) and resolved, supporting safety of 6-month surgery in medically fit infants

Written by the GCMD Library team from the infographic.

Three-panel infographic with red sidebar on left showing study details. Center panel displays anatomical illustration of cleft palate and branching arrows comparing two surgical timing groups. Right panel shows speech outcome comparison with downward arrow and percentage statistics. Color scheme uses red accents on white background with gray icons.

New infographic by Dr. Jose Campos and the Chilean society of Pediatric surgery

"Timing of Primary Surgery for Cleft Palate"

Authors: Carrol Gamble, Ph.D., Christina Persson, Ph.D., Elisabeth Willadsen, Ph.D., Liz Albery, M.Phil., Helene Soegaard Andersen, M.Sc., Melissa Zattoni Antoneli, Ph.D., Malin Appelqvist, M.Sc., Ragnhild Aukner, M.Sc.,Pia Bodling, M.Sc., Melanie Bowden, B.Sc., Karin Brunnegård, Ph.D., Gillian Cairns, B.Sc., PG.Cert., et al., for the TOPS Study Group*

Full article: https://www-nejm-org.uc.idm.oclc.org/doi/full/10.1056/NEJMoa2215162

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.)

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