Fistula incidence and predictors of fistula occurrence after cleft palate repair: two-stage closure versus one-stage closure.

OBJECTIVE: To review the clinical outcomes of our cleft palate team in terms of fistula rate and to determine whether gender, syndrome, cleft type, age at repair, operating surgeon, type of cleft repair, and cleft width influence the risk of fistula occurrence. Cleft palate repair was done in one- or two-stages.

DESIGN: A retrospective analysis was performed of medical records of 275 patients who underwent palate repair and who were born between 1988 and 1997. All consecutive cleft (lip and) palate patients (including syndromes) were incorporated. Multivariate analysis was performed to look for predictors of the formation of fistulas.

RESULTS: One hundred fifty-four and 121 patients underwent two-stage and one-stage repair, respectively. The median duration of follow-up was 9 years. The overall incidence of the formation of a fistula was 21%, with a recurrence rate of 9% after fistula repair. Three independent predictors of fistulization were found: palate repair in two stages, younger age at the second stage of a two-stage repair (≤3.0 years), and greater cleft width (≥13 mm). A fistula occurred in 27% of two-stage repairs versus 14% of one-stage repairs.

CONCLUSIONS: This study found a relatively high incidence of fistula formation after cleft palate repair. Although the study populations were not randomized, this study suggests that a two-stage closure has a higher rate of fistula formation when compared with a one-stage closure. This study demonstrates that cleft width at the time of cleft palate repair plays a crucial role in the development of fistulas.