Improving Outcomes in Cleft Palate Surgery

Not Applicable

Completed

• Conditions: Cleft Palate
• Interventions: Behavioral: Routine Feedback; Behavioral: Intensive Feedback

• Registration Number: NCT02583100
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.

Detailed Description

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Feedback	Routine Feedback	Participants in this arm will receive routine feedback on their complication rates.
Intensive Feedback	Intensive Feedback	Participants in this arm will receive intensive feedback on their complication rates, surgical technique, and peri-operative surgical management from peer surgeons participating in the study.

Primary Outcome Measures

Name	Time	Method
Oro-nasal Fistula	12 weeks	Presence or absence of fistula of the palate

Trial Locations

Locations (6)

Duke Children's Hospital; 🇺🇸 Durham, North Carolina, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Penn State Hershey Craniofacial Clinic; 🇺🇸 Hershey, Pennsylvania, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States