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The Rate of Oronasal Fistula Formation Following Primary Cleft Palate Surgery: A Meta-Analysis
Michael R. Bykowski, MD, Sanjay Naran, MD, Daniel F. Winger, BS, Joseph E. Losee, MD.
University of Pittsburgh, Pittsburgh, PA, USA.
The purpose of this study was to perform a meta-analysis to answer the questions: What is the rate of oronasal fistula formation following primary cleft palate repair, and what risk factors are associated with their development?
The Medline database was reviewed for English-written papers published between 2000 and 2012 with the search items: “cleft palate fistula” and “cleft palate surgery”. Inclusion criteria included: 1) primary cleft repair; 2) average or median age at time of surgery of 3 months; and 4) a clear description of an oronasal fistula as a communication between oral and nasal cavities. Exclusion criteria included: 1) pre-clinical animal studies; 2) case reports; 3) patients with a type V-VII fistula, as defined by the Pittsburgh Fistula Classification System; and 4) repair of submucous cleft palates. A random effects meta-analysis of proportions and exact confidence intervals was performed. For Veau classifications, an extension of the Cochran-Mantel-Haenszel Test for a series of 2x4 tables was utilized.
Of the 17 studies that met our inclusion criteria, 6 more were rejected because they were deemed to be statistical outliers. This resulted in 11 studies, comprising 2505 children, which were incorporated into our analysis. These studies were found to be statistically comparable to each other, meeting the homogeneity assumption with an acceptable I-squared value of 25.3% and a non-significant heterogeneity chi-squared p-value (0.203). The primary outcome targeted for analysis was the occurrence of an oronasal fistula, which we found to be 4.9% (95% CI 3.8-6.1%). There was a significant relationship between Veau classification and the occurrence of a fistula (p<0.001) with fistulae most prevalent in patients with a Veau IV cleft. The rate of fistula occurrence did not correlate to the surgical technique utilized for palate repair. The location of fistula, based upon the Pittsburgh Fistula Classification System, were as follows: Type I, 0.0%; Type II 12.7%; Type III, 54.0%; Type IV, 27.0%; with the remaining reported as a combination of locations not otherwise specified.
Evaluation of the rate of occurrence of oronasal fistulae following primary cleft palate repair is hindered by inconsistency of reporting surgical outcome details, inclusion or exclusion of submucous cleft palate repair, a wide range of patient populations, and differing surgical techniques. Utilizing 11 studies comprising 2505 children, we find the rate of fistula occurrence, defined as a true communication between the oral and nasal cavities, to be 4.9%. Furthermore, patients with a Veau IV cleft are significantly more likely to develop an oronasal fistula but use of decelluarized dermis may be protective. When fistulae do occur, they do so most often at the junction of the primary and secondary palate. A deeper understanding of fistula formation will help cleft palate surgeons improve their outcomes in the operating room and will allow them to effectively communicate expectations with patients’ families in the clinic.
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