An Investigation for the Optimal Timing of a Cleft Palate Repair

NCT ID: NCT00779961

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2023-12-31

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.

Conditions

Cleft Palate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Early Cleft Palate Repair (Age group 6-10 months)

Group Type: EXPERIMENTAL

Palatoplasty

Intervention Type: PROCEDURE

Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Group B

Sick Kids Routine cleft palate repair (age group 10-14 months)

Group Type: ACTIVE_COMPARATOR

Palatoplasty

Intervention Type: PROCEDURE

Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Interventions

Palatoplasty

Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Intervention Type: PROCEDURE

Palatoplasty

Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 5 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

David Fisher

Medical Director and Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Fisher, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000010915

Identifier Type: -

Identifier Source: org_study_id