Clinical trial NCT00779961: An Investigation for the Optimal Timing of a Cleft Palate Repair
Official title: An Investigation for the Optimal Timing of a Cleft Palate Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Palate
Keywords: pediatric
cleft palate
plastic surgery
palatoplasty
pharyngoplasty
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age.
timeFrame: 5 years
Secondary outcomes:
measure: Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded.
timeFrame: 6-8 weeks post-op
measure: Feeding Assessment: A feeding assessment will be conducted pre-surgery (5 months of age) and post surgery (6-8 weeks post-operatively).
timeFrame: 6-8 weeks post-op
measure: 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
timeFrame: 5 years of age, 11-13 years of age
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: David M Fisher, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: