NCT00779961

An Investigation for the Optimal Timing of a Cleft Palate Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 5 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft Palate

Interventions

Type	Name	Description
PROCEDURE	Palatoplasty	Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
PROCEDURE	Palatoplasty	Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Timeline

• Start date: 2008-04-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2008-10-24
• Last updated: 2022-03-24

Locations

1 site across 1 country: Canada