Abstract

Background: There is a lack of reliable information on outcomes following cleft surgery. Options for timing and choice of primary cleft surgery had not been compared in randomised trials.
 Methods: Non-syndromic infants, aged six months, with isolated cleft of the secondary palate without associated lip deformity, were included in this prospective randomised controlled trial to one of four options: Veau-Wardill-Kilner palatoplasty at six (VWK06) or 12 months of age (VWK12), or two-flap palatoplasty with intra-velar veloplasty at six (2F-IVV06) or 12 months of age (2F-IVV12). 
 Results: Of the 76 infants included in the trial, 90.8 per cent received surgery: VWK06 (n=18), VWK12 (n=16), 2F-IVV06 (n=18) and 2F-IVV12 (n=17). Early postoperative complications occurred in two VWK infants (6.1%) and three 2F-IVV infants (8.8%). With surgery planned at six (T06) and 12 months of age (T12) respectively, there were three VWK infants (8.6%) and two 2F-IVV infants (6.3%). At age three, speech assessments were conducted for 62 (84%) children. Velopharyngeal inadequacy symptoms were detected in 4/30 VWK children (13.3%) and 3/30 2F-IVV children (10.0%). With T06 and T12, there were three VWK infants (9.4%) and four 2F-IVV infants (14.3%). Otitis media was documented in 40/61 of children (65.6%) hyper- and/or hyponasality in 27/61 of children (44%) and articulation errors in 53/60 of children (88%).
 Conclusion: Postsurgical complication rates differ little between VWK and 2F-IVV. At three years, there were no demonstrable differences in velopharyngeal inadequacy symptoms, nasality, articulation and otitis media between the two surgical techniques at two different times.

Highlights

  • Rates of cleft of the lip and/or palate vary within and between ethnic groups and, for the Chinese, rates range from 1.45 to 4.04 per 1000.1 These defects may create problems in feeding, speech, hearing, dental development and facial growth

  • There were no demonstrable differences in velopharyngeal inadequacy symptoms, nasality, articulation and otitis media between the two surgical techniques at two different times

  • At the time of preparing the protocol, there was a lack of information on outcomes following cleft surgery and options for primary cleft surgery were not compared in randomised trials.[2]

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Summary

Introduction

Rates of cleft of the lip and/or palate vary within and between ethnic groups and, for the Chinese, rates range from 1.45 to 4.04 per 1000.1 These defects may create problems in feeding, speech, hearing, dental development and facial growth. At the time of preparing the protocol, there was a lack of information on outcomes following cleft surgery and options for primary cleft surgery were not compared in randomised trials.[2] Few centres used consistent approaches in technique, timing, sequence and ancillary interventions, making it impossible to identify the strategy providing the best results.[3]. A number of outcome scales and standards for reporting the results of surgery on individuals with clefts have been developed.[4,5,6]. There is a lack of reliable information on outcomes following cleft surgery. Options for timing and choice of primary cleft surgery have not been compared in randomised trials

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