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Randomized Controlled Trial
. 2018 Jul;142(1):42e-50e.
doi: 10.1097/PRS.0000000000004486.

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

Rajgopal R Reddy  1 , Srinivas Gosla Reddy  1 , Anusha Chilakalapudi  1 , Swapnika Kokali  1 , Ewald M Bronkhorst  1 , Ann W Kummer  1 , Stefaan J Bergé  1 , Anne Marie Kuijpers-Jagtman  1
Affiliations
Randomized Controlled Trial

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

Rajgopal R Reddy et al. Plast Reconstr Surg. 2018 Jul.

Abstract

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.

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References

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