Improving Outcomes in Cleft Palate Surg… | Clinical Trial

Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

About this study

This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair.

The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons.

The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Active surgeon performing cleft palate repair in the US or Canada.

Exclusion criteria

none

Treatment and study plan

Intensive Feedback

Behavioral

(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial, (2) receive an analysis of their video-recorded operative technique by surgeon peers, (3) directly observe a peer surgeon with lower fistula rate, and (4) develop a personalized action plan with a target for improvement.

Routine Feedback

Behavioral

(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial

Primary outcomes

Oro-nasal Fistula

Time frame: 12 weeks

Presence or absence of fistula of the palate

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Oct 21, 2015
Registry last updated: Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed