Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes
Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes
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.
Background and Purpose:

 Children born with cleft palate require surgical correction in order to prevent nasal
 regurgitation of food and in order to create normal palate function for speech. Uncorrected,
 speech is hypernasal and unintelligible. Normal speech has very few sounds that are normally
 nasal. In English, there are only three, "m" as in "Mama", "n" as in "no", and "ng" as in
 "ring". The remaining 43 sounds in English are made with the soft palate (or velum) closing
 off the nasopharynx, and projecting speech orally. The goal for surgical separation of the
 nose and mouth at the hard palate (palatoplasty) is to create a complete separation of the
 nose and mouth at the hard palate and a functioning soft palate that can open and close the
 nasopharynx appropriately for speech sound.

 Unfortunately, primary closure of the palate is not completely successful in all patients. In
 some patients, an opening (fistula) remains in the (anterior) hard palate allowing food and
 speech to leak through the nose. A second problem is that the (posterior) soft palate may not
 be long enough or move far enough to close off the nasopharynx. This is called a
 velopharyngeal incompetence. These patients may also suffer from nasal regurgitation and
 hypernasal, unintelligible speech. Both palatal fistula and velopharyngeal incompetence will
 require secondary surgery. Any information gained from review of surgical outcomes of the
 primary palatoplasty might improve surgical success and reduce the number of secondary
 surgeries required. This would reduce possible morbidity to the patient and expense to the
 families.

 The purpose of this review will be to evaluate the outcome of the palatoplasty children and
 follow through the Center for Craniofacial Disorders at Children's Healthcare of Atlanta on
 the Scottish Rite campus. The investigators will evaluate for the occurence of palatal
 fistula and velopharyngeal incompetence.

 Summary of Procedures:

 General Procedures: The clinical databases at the Center for Craniofacial Disorders will be
 evaluated Locations Involved: The Center for Craniofacial Disorders is at Children's
 Healthcare of Atlanta and is on the Scottish Rite campus Number of Subjects: 1295 patients
 have been treated since 1998.

 Potential Risks:

 There are no physical, psychological, or financial risks to the patients.

 Due to the nature of this records review study, information collected in this study will
 contain Protected Health Information (PHI) on subjects. There is the potential risk of
 unintentional disclosure of this information. However, certain steps will be followed in this
 study to minimalize PHI disclosure to help protect the subjects' privacy and confidentiality.
 Patient confidentiality wil be protected since the databases are on secure servers within the
 Children's network. The databases are password-protected and are accessible only to
 clinicians entering clinical notes and approved researchers. Other than institutions required
 by law to have access to research records, only authorized research staff will have access to
 the research database associated with the study. Furthermore, no data will be identifiable to
 study subjects, as each subject will be assigned a unique study number when entered into a
 database. If published or presented, no identifying features will be provided.

 Potential Benefits:

 There might be no immediate benefit to the patients whose records are evaluated. There is
 potential benefit to future patients seen at the Center. Evaluation of surgical outcomes
 might identify potential hazards that reduce the effectiveness of surgery. Efforts can be
 made to avoid these hazards in the future. The investigators might also find that certain
 surgical techniques or ages at surgery lead to better outcomes. Surgical protocol could be
 modified with the potential of improvement of surgical outcomes in the future.

 Informed Consent Process:

 Due to the nature of this retrospective records review study, informed consent from the
 subjects is not required and a Request for Waiver of Authorization was submitted. This
 research involves no more than minimal risk to the subjects, as there will be no subject
 contact and only the subjects' data will be utilized in the conduct of the research. There is
 the minimal risk of a breach in confidentiality with the subjects' PHI being disclosed,
 however, a procedure is in place for the protection of any collected PHI. The waiver of
 informed consent will not adversely affect the rights and welfare of the subject as this
 research does not change their standard of care and their confidentiality rights will be
 respected. This research could not be practicably carried out without the waiver of the
 informed consent as it is a retrospective chart review study where subject data is needed to
 meet the objectives of the study and consent cannot be practicably obtained from the
 patients. Whenever appropriate, the subjects will be provided with additional pertinent
 information after participation, however, in this case, the subjects' standard of care will
 not be affected so there will be no need for contact with subjects. The Request for Waiver of
 Authorization outlines the types of PHI that will be collected, protection and destruction
 plan for PHI, assurances against PHI re-disclosure, and the need for collection of PHI in
 order to conduct the study.
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