Timing of Primary Surgery for Cleft Palate

Posted by Carla Rothaus, MD

Published August 30, 2023

In the TOPS trial, how did outcomes among children who underwent cleft palate repair at 6 months of age compare with those among children who underwent repair at 12 months of age?

Gamble et al. conducted the Timing of Primary Surgery (TOPS) trial, an international, two-group, randomized, controlled trial that assessed whether primary surgery for cleft palate repair, with the use of a standardized technique, produced better speech outcomes when performed at 6 months of age than at 12 months of age. Read the NEJM Original Article here.

Clinical Pearls

Q: What are some of the difficulties faced by children with a cleft palate?

A: Depending on the type and severity of the defect, cleft palate may cause difficulty with communication, owing to abnormal speech development and hearing loss; feeding problems, particularly within the first year of life; aberrant dental development and facial growth; and psychological difficulties. For infants with cleft palate, the roles of surgical technique, age at the time of surgery, and number of surgeries in the optimization of speech development continue to be debated. Safety concerns related to airway obstruction and anesthesia are key reasons why some surgeons avoid repair in younger infants.

Q: Why is normalization of velopharyngeal function important in children with a cleft palate?

A: An important aim of primary palatal surgery is normalization of velopharyngeal function — that is, closure between the velum and pharyngeal walls to separate the oral and nasal cavities during speech and swallowing. This closure prevents oral–nasal coupling during speech, enabling intraoral air pressure sufficient for pressure consonants, which is a prerequisite for the normal development of prelinguistic behavior and speech.

Morning Report Questions

Q: In the TOPS trial, how did outcomes among children who underwent cleft palate repair at 6 months of age compare with those among children who underwent repair at 12 months of age?

A: In this trial, the percentage of children with velopharyngeal insufficiency at 5 years of age was significantly lower in the 6-month group than in the 12-month group (8.9% [21 of 235 children] vs. 15.0% [34 of 226 children]; risk ratio, 0.59; 95% confidence interval [CI], 0.36 to 0.99; P = 0.04). Canonical babbling (a developmental milestone when present before 10 months of age) at 1 year of age was present in a greater percentage of children in the 6-month group than in the 12-month group (difference, 20.7 percentage points). Maxillary arch constriction appeared to be greater in the 6-month group than in the 12-month group, but this finding was not considered to be clinically meaningful. The timing of surgery did not affect other growth outcomes. More children in the 6-month group required a secondary surgery for velopharyngeal insufficiency, whereas more children in the 12-month group required a secondary surgery for fistula.

Q: Was there an advantage to earlier cleft palate surgery with respect to hearing sensitivity and middle-ear function?

A: Children with cleft palate have a high risk of transient conductive hearing loss because of poor eustachian-tube function and middle-ear effusion. The hearing sensitivity and middle-ear function at 1 year of age appeared to be better in children who underwent surgical repair at the age of 6 months than in those who had yet to undergo surgery; this difference had disappeared by the assessment at 3 years of age. The number of children with a hearing test performed was low, and data on hearing sensitivity and middle-ear function are exploratory; however, the percentage of children with conductive hearing loss and middle-ear disease decreased with increasing age, irrespective of the age at primary surgery.