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Improving Outcomes in Cleft Palate Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02583100
Enrollment
7
Registered
2015-10-21
Start date
2015-10-31
Completion date
2018-09-30
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate

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.

Interventions

BEHAVIORALIntensive Feedback

(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.

BEHAVIORALRoutine Feedback

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

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

none

Design outcomes

Primary

MeasureTime frameDescription
Oro-nasal Fistula12 weeksPresence or absence of fistula of the palate

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026