Single-Stage Primary Cleft Lip and Palate Repair: Analysis of Early Complications

Background: Simultaneous primary cleft lip and palate (PCLP) surgery is controversial in the United States. As a result, most patients are treated with a staged approach including repair of the lip first, followed by palatal repair at approximately 1 year of age. In this study, we evaluate early postoperative complications of the single-stage PCLP repair, compared to primary cleft lip (PCL) or primary cleft palate (PCP) alone through the largest cohort study to date.

Methods: The ACS NSQIP-Pediatric database was used to identify patients undergoing single-stage PCLP, PCL or PCP repairs between the years 2012 and 2015. Preoperative factors and early postoperative outcomes were compared between the three groups, as well as within the PCLP group between patients with and without complications. Univariate and multivariate regression analyses controlling for potential confounders were performed.

Results: Review of the database identified 181 patients in the single-stage PCLP group, 1,007 in the PCP group, and 783 in the PCL group. On univariate analysis, there was a significant difference in mean age (p<0.001), weight (p<0.001), as well as distribution of gender (p<0.001), race (p=0.002), primary surgical service (p<0.001), and wound classification (p= 0.01). There was no difference in the rates of early complications between the three groups. Mean operative time was significantly different between the PCLP, PCP and PCP groups respectively (159.1 ± 66.8 vs. 142.1 ± 67.2 vs. 125.1 ± 59.4, p<0.001). Regression analysis was subsequently performed to control for potential confounders. Within the PCLP group, cardiac risk factors (β = 35.19; 95% CI: 7.88-75.21; p=0.04) and complications (β = 77.31; 95% CI: 35.82-118.79; p<0.001) were significant risk factors for longer operative time. The most common surgical complication after PCLP repair was superficial incisional surgical site infection (n=3).

Conclusions: Review of a national multi-center validated pediatric surgery database shows that single-stage primary cleft lip and palate repair is not associated with increased risk of early postoperative complications as compared to primary cleft lip or palate repair alone. Future in-depth analyses of functional outcomes, craniofacial morphology, and psychosocial outcomes are warranted to understand the long-term impact of single-stage primary cleft lip and palate repair.