Fistula incidence after primary repair and correlation with cleft width-to-palatum width ratio: A prospective cohort study

Background: Cleft lip with or without cleft palate is one of the most common birth defects and is certainly the most visible. Fistula rate after primary palatoplasty was ranging between 10 and 23% and could be detected in the first three weeks after surgery. The cleft width is the frequent factor which was assumed to correspond to fistula occurrence. This study aimed to find correlation between fistula occurrence with cleft width and palatum width ratio after primary palate repair. Methods: A prospective cohort study was conducted on 16 subjects, which consisted of 10 males and 6 females. We measured width of cleft palate, width of rest palate and width of palate arch on three level measurements (posterior, junction and anterior). The surgery was performed using the two-flap and three layers suturing technique. Results: Sixteen patients were enrolled in this study during January and February 2008 . Ten patients were diagnosed with unilateral cleft palate while six patients had bilateral cleft palate. Mean of age was 22.31 +/- 5.86 month. Correlation analysis between fistula occurrence and cleft width, cleft width-remnant palate width ratio and cleft width-palate arch width ratio using logistic regression did not show statistical correlation, and the same result was found between fistula occurrence and hemoglobin level, white blood count, nutritional status, cleft type and caries dentis factors (p > 0.05). Conclusion: Width of the cleft is not a factor associated with fistula occurrence. Two-flap three layers technique could be considered as a simple technique and gives a low rate of fistula occurrence.