Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes
1 other identifier
observational
1,295
1 country
1
Brief Summary
Children who are born with cleft palate need surgery in order to correct the problem. The surgery is needed because the defect allows food to leak into the nose. It also causes the patient to be unable to speak correctly, producing a problematic nasal sound. Sometimes the first surgery does not completely correct the problem and a second surgery is needed. Looking at the records of patients who have had corrective surgeries done in the past would allow the surgeons to improve their success rate and reduce the need for secondary surgeries. It would also create greater patient safety and reduce cost for families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedJune 27, 2011
June 1, 2011
2.8 years
May 24, 2010
June 24, 2011
Conditions
Study Arms (1)
Cleft lip/palate
Patients who have had surgical intervention for cleft lip/palate since 1998 at Children's Healthcare of Atlanta at the Center for Craniofacial Disorders
Eligibility Criteria
1295 patients with cleft lip/palate that have been treated since 1998 at the Center for Craniofacial Disorders at Children's Healthcare of Atlanta on the Scottish Rite campus.
You may qualify if:
- Children operated on by surgeons at the Center for Craniofacial Disorders
- Have a diagnosis of cleft lip/palate
- Children with a syndrome in addition to cleft lip/palate will be evaluated in a different category
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Riski, PhD
Children's Healthcare of Atlanta
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2010
First Posted
June 27, 2011
Study Start
February 1, 2007
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
June 27, 2011
Record last verified: 2011-06