Over their lifetimes, children with cleft palate + lip (CP+L) undergo numerous surgical, orthodontic, and behavioral interventions designed to lessen the impact of clefting. There is genuine uncertainty within the expert medical community about the preferred surgical approaches to cleft palate repair. As a result, treatment decisions are based on treating biases from prior training, clinical experiences, or provider expertise. The proposed project intends to compare the two most common cleft palate repair techniques, straight- line closure with intra-velar veloplasty (IVVP) and Furlow Z-plasty palatal lengthening, to determine their effect on speech outcome and on the subsequent development of fistulas, a common adverse event following surgical repair of the palate. Instead of efficacy, the study of interventions in a select population under ideal conditions, the target of the proposed study is effectiveness, the comparison of these techniques in real-world clinical settings and across the full continuum of severity and comorbidity seen in clinical care ? data that are sorely needed to inform medical decision making for CP+L. In addition, we will collect detailed information on post-operative and follow-up care as well as speech-language therapy practices to illuminate the full horizon of early care practices for CP+L. To achieve this real-world data capture, we will establish a multi-institutional, point-of-care data capture system that harmonizes the practice data from leading cleft care programs across North America. The completion of this proposed project will advance knowledge about surgical approaches to CP+L as well as subsequent inpatient and outpatient care. The authentic and detailed care information about how different individuals respond to surgical interventions would help providers deliver the right care at the right time to the right patient. Better characterization of therapy interventions would inform the development of care pathways for outpatient CP+L care that have the potential to realize more informed, effective and equitable care. Finally, in addition to the direct impact on care that can be realized by the hypothesis testing proposed herein, the establishment of a point-of-care data capture clinical research registry for CP+L holds the potential to be an enduring contribution to the field and to support conduction of timely and clinically relevant research for years to come.
The details of surgical care and speech-language therapy provided for children with cleft palate have not been thoroughly studied. The goal of the proposed project is to compare two surgical approaches to primary cleft palate repair and characterize the follow-up care and therapy that patients receive. The completion of this project will help identify the surgical techniques that produce the best outcomes for patients with cleft palate.
