Pharyngeal flap and sphincterplasty for velopharyngeal insufficiency have equal outcome at 1 year postoperatively: results of a randomized trial.

Abstract

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.

• Authors: Frank Abyholm, Linda D'Antonio, Sally L Davidson Ward, Lillian Kjøll, Muhammad Saeed, William Shaw, Gerald Sloan, David Whitby, Helen Worhington, Rosemary Wyatt, VPI Surgical Group
• Journal: The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association (Cleft Palate Craniofac J) Vol. 42 Issue 5 Pg. 501-11 (Sep 2005) ISSN: 1055-6656 [Print] United States
• PMID: 16149831 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Topics

• Adolescent
• Adult
• Child
• Child, Preschool
• Cleft Palate (surgery)
• Endoscopy
• Follow-Up Studies
• Humans
• Pharyngeal Muscles (surgery)
• Pharynx (surgery)
• Postoperative Complications
• Single-Blind Method
• Sleep Apnea Syndromes (etiology)
• Speech Disorders (therapy)
• Speech Intelligibility (physiology)
• Surgical Flaps
• Treatment Outcome
• Velopharyngeal Insufficiency (surgery)