Risk of persistent palatal fistula in patients with cleft palate.

IMPORTANCE: Many individuals with a cleft palate also have an associated craniofacial syndrome or anomaly.

OBJECTIVE: To investigate the predictive associations of persistent palatal fistulas in patients with previously repaired cleft palate.

DESIGN, SETTING, AND PARTICIPANTS: We performed a case-control study of patients with cleft palate repairs from January 1, 1986, through December 31, 2000, at a major tertiary care hospital center in the Bronx, New York. The study population consisted of patients who had their primary surgery before the age of 3 years and had all their cleft-related treatment completed at the same hospital center. Palatal fistula was defined as a breakdown of the primary surgical repair of the palate, resulting in persistent patency between the oral and nasal cavities. Data collection was conducted by using the hospital centers' electronic medical records and patient tracking systems and confirmed by review of hard copies of patient records.

MAIN OUTCOMES AND MEASURES: The Veau classification system was used to classify the preoperative cleft severity.

RESULTS: A total of 130 patients were identified-23 patients with palatal fistula and 107 controls. A total of 12 girls and 11 boys were identified in the palatal fistula group and 56 girls and 51 boys in the control group. The mean patient age at the time of palatoplasty was 12.6 and 14.5 months in the palatal fistula and control groups, respectively. A statistically significant association was found between the outcome of fistula and severity of cleft, as defined by the Veau classification system (P = .01). Furthermore, for each Veau class increase, the odds of a palatal fistula increased by 2.64 (95% CI, 1.35-5.13; P = .004). No statistically significant associations were found between the outcome of fistula and the following independent variables: patient sex (P = .98), patient age at palatoplasty (P = .82), type of palatoplasty (P = .57), surgeon (P = .15), orthodontic treatment (P = .59), ear infection (P = .30), or clefts associated with syndromes (P = .96).

CONCLUSIONS AND RELEVANCE: Palatal fistulas are reliably associated with severity of cleft, as defined by the Veau classification system. This knowledge gives the health care professional a more reliable method of preoperatively assessing the risk of postoperative palatal fistula in the cleft palate population.

LEVEL OF EVIDENCE: 3.