On randomised trials of surgical timings for cleft palate repair

Abstract

Background: In this article we review randomised controlled trials (RCTs) comparing palatal surgery at different ages to examine their design features and quantify their conclusions. Method: A literature search of RCTs comparing surgical timings for cleft palate and/or lip repair from 1 January 2004 to 31 December 2013 was undertaken. This supplements an earlier systematic review of 62 RCTs in cleft lip and palate from 1 January 2004 to 31 December 2013 in English using the Cochrane Central Register of Controlled Trials, MEDLINE® and EMBASE with key words ‘cleft lip’ or ‘cleft palate’. Results: Four RCTs were identified, each comparing palate surgery at different lower (six, nine and 12 months) and upper (12, 18 and 36 months) ages with velopharyngeal competence (VPC) also at different ages (three, four, more than four or five years). These surgical and assessment age differences prevent a synthesis using meta-analysis techniques. Nevertheless, three RCTs indicate that VP function is more impaired with later surgery. Two ask questions about the type of surgery; one suggests that VPC is greater with Furlow palatoplasty than von Langenbeck surgery and the other that one technique appears to have better VPC at six months and the other at 12 months. Conclusion: The role of the timing of palatal surgery with respect to VPC remains unclear. We propose an international strategy that is designed to establish the optimal age for palatal surgery in infants requiring palate and/or lip repair.