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Cleft Palate Surgery and Speech Development

Primary Purpose

Cleft Lip, Cleft Palate

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Furlow double z-plasty palatoplasty palate repair
Von Langenbeck palatoplasty palate repair
Sponsored by
University of Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip focused on measuring cleft lip and palate, children, speech, velopharyngeal function, congenital facial malformation, von Langenbeck procedure, Furlow procedure, cleft lip and palate repair, Unilateral cleft lip and palate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 1999
Last Updated
September 16, 2011
Sponsor
University of Florida
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00004639
Brief Title
Cleft Palate Surgery and Speech Development
Official Title
Velopharyngeal Function for Speech After Palatal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 1996 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip, Cleft Palate
Keywords
cleft lip and palate, children, speech, velopharyngeal function, congenital facial malformation, von Langenbeck procedure, Furlow procedure, cleft lip and palate repair, Unilateral cleft lip and palate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
475 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Furlow double z-plasty palatoplasty palate repair
Intervention Type
Procedure
Intervention Name(s)
Von Langenbeck palatoplasty palate repair
Primary Outcome Measure Information:
Title
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.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William N Williams, Ph.D
Organizational Affiliation
Univerisity of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32166
Country
United States
Facility Name
Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17043-900
Country
Brazil

12. IPD Sharing Statement

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Cleft Palate Surgery and Speech Development

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