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Variation among cleft centres in the use of secondary surgery for children with cleft palate: a retrospective cohort study.

ABSTRACT: To test whether cleft centres vary in their use of secondary cleft palate surgery, also known as revision palate surgery, and if so to identify modifiable hospital- and surgeon-factors that are associated with use of secondary surgery.Retrospective cohort study.Forty-three paediatric hospitals across the United States.Children with cleft lip and palate who underwent primary cleft palate repair from 1999 to 2013.Time from primary cleft palate repair to secondary palate surgery.We identified 4,939 children who underwent primary cleft palate repair. At ten years after primary palate repair, 44% of children had undergone secondary palate surgery. Significant variation existed among hospitals (p<0.001); the proportion of children undergoing secondary surgery by 10 years ranged from 9% to 77% across hospitals. After adjusting for patient demographics, primary palate repair before nine months of age was associated with an increased hazard of secondary palate surgery (initial hazard ratio 6.74, 95% CI 5.30-8.73). Postoperative antibiotics, surgeon procedure volume, and hospital procedure volume were not associated with time to secondary surgery (p>0.05). Of the outcome variation attributable to hospitals and surgeons, between-hospital differences accounted for 59% (p<0.001), while between-surgeon differences accounted for 41% (p<0.001).Substantial variation in the hazard of secondary palate surgery exists depending on a child's age at primary palate repair and the hospital and surgeon performing their repair. Performing primary palate repair before nine months of age substantially increases the hazard of secondary surgery. Further research is needed to identify other factors contributing to variation in palate surgery outcomes among hospitals and surgeons.

SUBMITTER: Sitzman TJ

PROVIDER: S-EPMC5823530 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Variation among cleft centres in the use of secondary surgery for children with cleft palate: a retrospective cohort study.

Sitzman Thomas J TJ Hossain Monir M Carle Adam C AC Heaton Pamela C PC Britto Maria T MT

BMJ paediatrics open 20170501 1

<h4>Objectives</h4>To test whether cleft centres vary in their use of secondary cleft palate surgery, also known as revision palate surgery, and if so to identify modifiable hospital- and surgeon-factors that are associated with use of secondary surgery.<h4>Design</h4>Retrospective cohort study.<h4>Setting</h4>Forty-three paediatric hospitals across the United States.<h4>Patients</h4>Children with cleft lip and palate who underwent primary cleft palate repair from 1999 to 2013.<h4>Main outcome m ...[more]

PMID: 29479567

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Project description:BackgroundAmong 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.MethodsWe 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.ResultsWe 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.ConclusionsMedically 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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Variation among cleft centres in the use of secondary surgery for children with cleft palate: a retrospective cohort study.

Publications

Variation among cleft centres in the use of secondary surgery for children with cleft palate: a retrospective cohort study.

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