Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial

Background: Is one or two-stage palatoplasty more effective preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate? Methods: This parallel blocked randomized controlled trial included 100 patients with non-syndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into 2 groups of 50 each. Group A had one-stage palatoplasty at age 12-13 months while group B had two-stage palatoplasty with soft palatoplasty at age 12-13 months and hard palatoplasty at age 24-25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C were the non-cleft controls (n=20, age 6 years) for speech using nasometry. Fistula rates, ratings of hypernasality and nasalance scores were compared between groups A and B. Nasometry recordings of group A and B were compared with control group C. Results: There was no difference in fistula rates between groups A and B (p=0.409; 95% CI=[0.365...11.9]). Mean nasalance scores of group A showed higher nasalance than group B (p=0.006, 95CI=[1.16…6.53]). Perceptual analysis showed no difference between groups A and B (p=0.837 and p=1.000). When compared to group C, Group A showed higher mean nasalance (p=0.837 and p=1.000) while group B showed no difference (p=0.088, 95% CI=[-0.14…2.02]). Conclusion: There was no difference in fistula rates between groups. Nasalance was slightly higher in patients who had one-stage palatoplasty when compared to those that had two-stage palatoplasty, but the difference may not be clinically significant. Financial disclosure and products page: Sources of funds supporting the work This study was partly funded by the former World Health Collaborating Centre, Radboudumc Nijmegen, The Netherlands. Statement of financial interest No financial interest to declare Corresponding Author: Rajgopal R. Reddy, Deputy Director, GSR Institute of Craniofacial Surgery, # 17-1-383/55, Vinay Nagar Colony, I. S. Sadan, Saidabad, Hyderabad- 500 059, Telephone:+91405764884, Facsimile: +91 40 24530000, Email: raj@craniofacialinstitute.org ©2018American Society of Plastic Surgeons