Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes

This study has been completed.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT01380171
First received: May 24, 2010
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.


Condition
Cleft Lip
Cleft Palate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 1295
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380171

Locations
United States, Georgia
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: John Riski, PhD Children's Healthcare of Atlanta
  More Information

Additional Information:
No publications provided

Responsible Party: John Riski, PhD, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT01380171     History of Changes
Other Study ID Numbers: 06-196
Study First Received: May 24, 2010
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 19, 2014