BACKGROUND: Is one-stage or two-stage palatoplasty more effective for 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 nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 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 consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups 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 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, -0.14 to 2.02). CONCLUSIONS: There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
RCT Entities:
BACKGROUND: Is one-stage or two-stage palatoplasty more effective for 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 nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 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 consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups 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 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, -0.14 to 2.02). CONCLUSIONS: There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
Authors: Jeremie D Oliver; Shihai Jia; Leslie R Halpern; Emily M Graham; Emma C Turner; John S Colombo; David W Grainger; Rena N D'Souza Journal: Tissue Eng Part B Rev Date: 2020-09-28 Impact factor: 7.376