Objective The aim of this trial was to compare the relative effectiveness (efficacy and morbidity) of two surgical procedures for correcting velopharyngeal insufficiency (VPI). Design This was an international multicenter randomized trial to study the outcome of two surgical procedures (flap and sphincter pharyngoplasty) for speech, incidence of sleep apnea, and surgical complications. Method Ninety-seven patients 3 to 25 years old with repaired cleft palate and previously identified VPI were enrolled from five centers in the United States, Norway, and the U.K. Data were collected at presurgery, 3 months postsurgery, and 12 months postsurgery for subsequent analysis blind to the procedure. Main outcome measures included perceptual speech parameters, sleep apnea, nasalance measures, endoscopic features, and surgical complications. Results Groups for both surgical procedures achieved a high level of clinical improvement. At 3 months postsurgery, elimination of hypernasal resonance was achieved in twice as many patients after the flap procedure. This reached significance. However, at 12 months postsurgery, no statistically significant difference in outcomes remained between the two procedures for resonance, nasalance, endoscopic outcomes, or surgical complications. Flap and sphincter pharyngoplasty rarely resulted in clinically significant sleep apnea, and no difference was detected between the two procedures in the long-term incidence of sleep apnea. Conclusions Despite strongly held views in the literature concerning the relative effectiveness and safety of flap and sphincter pharyngoplasty, no significant differences were detected 1 year postoperatively.
Fissure Seal or Fluoride Varnish? A Randomized Trial of Relative Effectiveness
