An Investigation for the Optimal Timing of a Cleft Palate Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00779961
First received: October 23, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids) routine palatal repair in isolated cleft palate patients by comparing speech development, velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference in speech development, velopharyngeal functioning and facial growth between early palatal repair and SickKids routine palatal repair in isolated cleft palate patients.


Condition Intervention Phase
Cleft Palate
Procedure: Palatoplasty
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation for the Optimal Timing of a Cleft Palate Repair

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded. [ Time Frame: 6-8 weeks post-op ] [ Designated as safety issue: Yes ]
  • Feeding Assessment: A feeding assessment will be conducted pre-surgery (5 months of age) and post surgery (6-8 weeks post-operatively). [ Time Frame: 6-8 weeks post-op ] [ Designated as safety issue: Yes ]
  • Dental and Facial Growth Disturbances measured in patients with isolated secondary plate cleft by analysis of the severity of their malocclusion,and performing a lateral cephalometric analysis [ Time Frame: 5 years of age, 11-13 years of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: April 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Early Cleft Palate Repair (Age group 6-10 months)
Procedure: Palatoplasty
Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
Active Comparator: Group B
Sick Kids Routine cleft palate repair (age group 10-14 months)
Procedure: Palatoplasty
Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Detailed Description:

The goals of palatoplasty are to provide an intact palate and to create a normally functioning velopharyngeal mechanism as early as possible without hazard to other aspects of health and development. Two major criteria by which the success of cleft palate surgery is determined are subsequent speech development and facial growth. Therefore, the debate about timing of cleft palate surgery is focused on the need for early palatoplasty for speech purposes versus later palatoplasty to ensure undisturbed facial growth. A compromise solution to this controversy was proposed by Schweckendiek; the soft palate is repaired at an early age leaving the hard palate cleft unrepaired until later in life. The premise is that primary veloplasty will result in a functioning velopharyngeal mechanism for early speech development, while the unrepaired hard palate will allow unrestricted maxillary growth. The speech outcomes of patients who have undergone delayed stage palate repair have been addressed in several studies and case series. However, there is little evidence to support the benefits of delayed stage repair with respect to facial growth and speech development. Results from published studies have shown the speech results to be relatively poor and fistula rates as unacceptably high. These results have lead a vast majority of North American surgeons to favour primary one-stage repair. Yet, the optimum timing of primary palate repair remains unknown. No randomized control trials or prospective cohort studies have been conducted to address this question.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant diagnosed with non-syndromic isolated unrepaired cleft involving the secondary palate.
  • Between newborn and 5 months of age (pre-palate surgical assessment/ consultation.
  • Treated at SickKids.

Exclusion Criteria:

  • If they are non-Ontario residents;
  • If they have clinical features suggestive of an associated syndrome and/or an associated syndrome;
  • If they have Pierre Robin sequence;
  • If the palate repair cannot be performed before 15 months of age;
  • If the extent of clefting is limited to the primary palate or submucous cleft of the soft palate;
  • If the child have a combined cleft lip and palate diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779961

Contacts
Contact: David M Fisher, MD, FRCSC 416-813-6445 david.fisher@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: David M Fisher, MD, FRCSC    416-813-6445    david.fisher@sickkids.ca   
Principal Investigator: David M Fisher, MD, FRCSC         
Sub-Investigator: Simone Fischbach, MHSC, SLP         
Sub-Investigator: Paula Klaiman, BSc, M.ClSc         
Sub-Investigator: John Daskalogiannakis, DDS, MSc.         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: David M Fisher, MD, FRCSC The Hospital for Sick Children, Toronto, Canada
  More Information

No publications provided

Responsible Party: David M Fisher MD, FRCSC, FACS, The Hospital for Sick Children, Toronto, Canada
ClinicalTrials.gov Identifier: NCT00779961     History of Changes
Other Study ID Numbers: 1000010915
Study First Received: October 23, 2008
Last Updated: October 23, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatric
cleft palate
plastic surgery
palatoplasty
pharyngoplasty

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 15, 2014