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A Novel Protocol In Early Cleft Lip Repair: Demonstrating Efficacy And Safety In The First 100 Patients.
Jordan Wlodarczyk, M.D., M.S.1, Erik Wolfswinkel, M.D.1, Artur Fahradyan, M.D.1, Pedram Goel, B.S.1, Alice Liu, B.A.1, Emma Higuchi2, Waleed Gabriel, M.D.1, William Magee, III, M.D., D.D.S., F.A.C.S1, Mark Urata, M.D., D.D.S., F.A.C.S1, Jeffery Hammoudeh, M.D., D.D.S., F.A.C.S1.
1CHLA, Los Angeles, CA, USA, 2Stanford University, Stanford, CA, USA.

PURPOSE:
Orofacial clefts are a prevalent birth defect that affects approximately 7.75 neonates out of every 10,000 live births. The optimal timing for repair of the cleft lip has yet to be objectively validated and previous supporting evidence guiding ideal timing may be outdated. Earlier repair takes advantage of the high degree of plasticity within the nasal cartilage and maxilla as a result of high concentrations of circulating maternal estrogen in the infant. Accomplishing the operative repair of the cleft lip in infancy has the capacity to decrease restrictive scar formation, improve aesthetic outcomes, accelerate weight gain, and improve feeding and maternal-infant socialization. In this study, we present patients prospectively enrolled in an early cleft lip repair (ECLR) multidisciplinary protocol created to facilitate the safe and effective repair of the cleft lip and nostril.
METHODS:
Orofacial cleft patients under 62 days of life who presented to Children's Hospital of Los Angeles between February 2015 and August 2019 were enrolled. Chart review abstracted patient demographics, cleft characteristics, cleft width ratio (defined as cleft width divided by commissure length), operative data, anesthetic data, nasal stent data, and complication and readmission rates. Basal view 3D photographs were taken preoperatively and at regular postoperative intervals. Measurements collected were nasal base width (NBW), nostril height (NH), columella length (CL), and columellar angle (CA). The cleft side measurements were compared to non-cleft side measurements to create ratios approximating nasal symmetry. Changes in preoperative and postoperative measurements were analyzed for significance.
RESULTS:
104 patients met inclusion criteria (96 unilateral and 8 bilateral clefts). The operative and anesthetic complication rates were each 1%. The mean age at operation was 33 14 days, length of stay was 1 0 days, and operative time and anesthetic time were 123 38 minutes and 179 36 minutes, respectively. The mean cleft width ratio was 0.47 0.08. The preoperative and postoperative NBW, NH, CL, and CA were 1.83 0.56 vs. 1.08 0.17 (p<0.001), 0.81 0.14 vs. 0.89 0.13 (p<0.001), 0.72 0.16 vs. 0.91 0.13 (p<0.001), and 19.8 8.4 vs. 8.5 5.5 (p<0.001), respectively.
CONCLUSION:
ECLR is safe, effective, and improves the nasal symmetry and can be safely performed in a pediatric hospital with the necessary resources. Widespread implementation of this protocol has the potential to be a paradigm shift in the treatment for all unilateral cleft lip and nasal deformities.


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