Cleft Palate Surgery and Speech Development

Phase 2

Completed

• Conditions: Cleft Lip; Cleft Palate

• Registration Number: NCT00004639
• Lead Sponsor: University of Florida

Brief Summary

Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech.

Detailed Description

This study is conducted with patients with complete unilateral cleft lip and palate. The subjects will have their palatal clefts surgically repaired by either the von Langenbeck or the Furlow double z-plasty palatoplasty. Patients will be randomly assigned to four groups, to have with the von Langenbeck palatoplasty with intravelar veloplasty or the Furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. Lip repair will be randomized to either the Spina or Millard method and will be accomplished by six months prior to palatoplasty. The major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech.

Study Timeline

• Study Start: 1996-02
• Study First Submitted: 1999-09-17
• Study First Submitted QC: 1999-09-17
• Study First Posted: 1999-09-20
• Primary Completion: 2006-03
• Study Completion: 2007-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

• Unrepaired unilateral cleft lip and palate
• Lip repair surgery to be accomplished by 3-6 months of age
• Able to return to research site at least once a year for follow-up

Exclusion Criteria

• Patients with concomitant conditions (ie. mental retardation, deafness)
• Patients with Simonart Band of the cleft
• Patients who could not return to research site on a yearly basis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality.	6 months

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC); 🇧🇷 Bauru, Sao Paulo, Brazil