We retrospectively reviewed 119 consecutive patients who underwent cleft palate repair at the Mayo Clinic to determine the incidence of postoperative fistula formation, to assess possible contributing factors, and to review the methods of surgical management. Fistulas of the secondary palate were included, but nasal-alveolar fistulas and intentionally unrepaired anterior palatal fistulas were excluded. Six patients whose repairs were performed after 2.5 years of age were excluded to ensure a more uniform patient population. Cleft palate fistulas occurred in 13 of the 113 patients (11.5 percent). The median age at repair was 8.2 months, and the median follow-up period was 5.2 years. Several variables were analyzed by means of the log-rank test to determine their significance in postoperative fistula formation. Sex, extent of clefting (as estimated by the Veau classification), and type of palatal closure did not significantly affect the rate of fistula formation. However, patients who had palatal closure at an age younger than 12 months had a lower incidence of fistula formation (7.8 percent) than children whose closures were performed between the ages of 12 and 25 months (19.4 percent) (p = 0.058). The strongest predictor of the occurrence of a cleft palate fistula was the surgeon performing the procedure (p = 0.008). Fistula repair was deemed necessary in 11 of 13 patients, and 91 percent of these fistulas were healed with a single operation. Most of these fistulas were closed by using local flaps and two-layered closures. Cleft palate repair carries a significant but acceptable risk of fistula formation, which can be managed with local flaps. Fistula occurrence is related most to the experience level of the operating surgeon.
issue of the Archives, studying the effect of somatostatin on healing of gastrointestinal fistulas. Torres and colleagues studied two populations of 20 patients each with gastrointestinal fistulas, treating one group with total parenteral nutrition (TPN) alone and the other with TPN and intravenous somatostatin infusion. They concluded that there was no significant difference in the percentage of fistulas that closed, but patients treated with TPN and somatostatin experienced closure of fistulas within a significantly shorter period than patients treated with TPN alone.However, during the performance of their study, the investigators transferred four patients from the TPN\x=req-\ alone group to the TPN plus somatostatin group. These four randomized patients, therefore, were excluded from analysis. We believe that this error impaired the credibility of the trial, and if these excluded patients had remained in their original group, the authors' hypothesis would have been more strongly supported.In addition, the failure to achieve a statistically significant difference in the spontaneous closure rate was un¬ doubtedly due to their sample size.On the basis of statistical power anal¬ ysis, the authors would have needed a sample size of 390 patients in each group to be 90% sure of detecting an increase in the closure rate from 80% in the TPN group to 90% in the TPN plus somatostatin group, using a two-sided test with a type I error rate of 5%. Certainly, no surgical group would wish to encounter such large numbers of patients with fistulas.Furthermore, we were intrigued by the supranormal dosages of soma¬ tostatin used in the study (250 jxg/h).We commend the authors on their study.
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