Comparison of Lip Revision Rates in Traditional Versus Early Cleft Lip Repair: An Institutional Review.

Abstract

Background: Traditional cleft lip repair (TLR) is performed between 3 and 6 months of age. For over 10 years, our institution has transitioned from offering presurgical nasoalveolar molding (NAM) before cleft lip repair to performing early cleft lip repair (ECLR) within 2 to 5 weeks of life, circumventing the use of NAM.

Purpose: This study aimed to estimate and compare the lip revision rates between patients who underwent ECLR versus TLR ± NAM.

Study design, setting, sample: A retrospective cohort study was conducted. Patients with nonsyndromic unilateral cleft lip who underwent primary repair between 2004 and 2021 at Children's Hospital Los Angeles were included. Exclusion criteria were as follows: American Society of Anesthesiologists classification III or higher, syndromic or bilateral cases, gestational-corrected age of more than 6 months at lip repair, and less than 2 years of follow-up.

Predictor variable: The predictor variable was the timing of primary cleft lip repair. Subjects were allocated to 1 of 2 treatment cohorts: ECLR (<3 months) and TLR ± NAM (3 to 6 months).

Main outcome variable: The primary outcome was lip revision surgery at any time during the patient's cleft care. Secondary outcomes included the extent and timing of the revision surgeries.

Covariates: Data collection included presurgical NAM use, surgeon, cleft phenotype, and cleft width ratio.

Analyses: A 2-phased coarsened exact matching process was performed to match cohorts based on surgeon, cleft phenotype, and cleft width ratio at a 1:1 ratio. Kaplan-Meier analyses were used to estimate and compare the revision rates.

Results: A total of 1,101 patients underwent primary repair during the study period. After applying the exclusion criteria, 362 patients remained before matching. Among these, 154 patients (77 ECLR, 77 TLR ± NAM) were included after matching. Kaplan-Meier analysis estimated a lower 5-year revision rate for the ECLR cohort compared to the TLR ± NAM cohort (17.3 vs 32.6%, log-rank P < .05). Median follow-up time was 6.6 years [interquartile range 4.4 to 9.2].

Conclusions and relevance: ECLR resulted in approximately a 2-fold reduction in lip revision rates compared with TLR ± NAM. These findings suggest that cleft lip repair at approximately 1 month of age may decrease the burden of secondary procedures later in life.