The Cleft Palate–Craniofacial Journal 52(4) pp.

e81–e87 July 2015

Ó Copyright 2015 American Cleft Palate–Craniofacial Association

ORIGINAL ARTICLE

The Rate of Oronasal Fistula Following Primary Cleft Palate Surgery:

A Meta-Analysis
Michael R. Bykowski, M.D., M.S., Sanjay Naran, M.D., Daniel G. Winger, M.S., Joseph E. Losee, M.D.

Background: Despite decades of craniofacial surgeons repairing cleft palates, there is no

consensus for the rate of fistula formation following surgery. The authors present a meta-
analysis of studies that reported on primary cleft palate to determine the rate of oronasal fistula
and to identify risk factors for their development.
Methods: A literature search for the period between 2000 and 2012 was performed. Articles
were queried and strict inclusion and exclusion criteria were applied to focus on primary cleft
palate repair. A meta-analysis of these data was conducted.
Results: The meta-analysis included 11 studies, comprising 2505 children. The rate of
oronasal fistula development was 4.9% (95% confidence interval, 3.8% to 6.1%). When analyzing
a larger cohort, there was a significant relationship between Veau classification and the
occurrence of a fistula (P , .001), with fistulae most prevalent in patients with a Veau IV cleft. The
most common location for a fistula was at the soft palate-hard palate junction. One study used
decellularized dermis in cleft repair with a fistula rate of 3.2%.
Conclusions: Using 11 studies comprising 2505 children, we find the rate of reported fistula
occurrence to be 4.9%. Furthermore, patients with a Veau IV cleft are significantly more likely to
develop an oronasal fistula. When fistulae do occur, they do so most often at the soft palate-hard
palate junction. 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.

KEY WORDS: cleft palate, fistula, meta-analysis, oronasal fistula, palatoplasty

Oronasal fistulae (ONF) are the bane of the cleft
palate surgeon. Although there is exhaustive literature
of individual and institutional experience and compli-
cations following primary cleft palate repair, the lack of
a standardized definition of what constitutes a fistula
results in a wide range of rates of occurrence, from 0.7%
to .60% (Cohen et al., 1991; Rohrich et al., 1996;
Emory et al., 1997; Muzaffar et al., 2001; Eberlinc and
Kozelj, 2012; Mahoney et al., 2013). Comparative
analysis has been made more difficult given the
inconsistency of reporting surgical outcome details,
inclusion or exclusion of submucous cleft palate repair,
a wide range of patient populations, and myriad
surgical techniques. Many factors have been suggested
to increase risk for development of an ONF, including
surgeon’s experience (Jackson et al., 2004), Treacher
Collins syndrome (Bresnick et al., 2003), extent of cleft,
procedure selection (Bekerecioglu et al., 2005; Bind-
ingnavele et al., 2008; Steinbacher et al., 2011), and age
at palatal closure (Bresnick et al., 2003). In the face of
these challenges, the goal of this study was to perform a
meta-analysis to answer the questions: What is the rate
of ONF formation following primary cleft palate repair,
and what risk factors are associated with their develop-
ment?

Dr. Bykowski is Resident and Dr. Naran is Resident, University

of Pittsburgh Medical Center, Department of Plastic Surgery; Mr.
Winger is graduate student, University of Pittsburgh, Department
of Statistics; Dr. Losee is Professor, Children’s Hospital of
Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh,
Pennsylvania.
This paper was presented at the 59th Plastic Surgery Research
Council Annual Meeting, March 7–9, 2014, in New York City at The
Conrad Hotel; and the 71st Annual Meeting of the American Cleft
Palate–Craniofacial Association, March 24–29, 2014, at the Indiana-
polis Downtown Marriott Hotel, Indianapolis, Indiana.
Submitted July 2014; Accepted June 2014.
Address correspondence to: Dr. Joseph E. Losee, 45th and Penn,
Pittsburgh, PA 15210. E-mail joseph.losee@chp.edu.
DOI: 10.1597/14-127
METHODS
Literature Search
The MEDLINE database was systematically reviewed
for papers written in English and published between
January 1, 2000, and October 1, 2012, using the
following search items: ‘‘cleft palate fistula’’ and ‘‘cleft
palate surgery.’’ These search items were arranged using
the Boolean operator ‘‘NOT.’’ Additional searches were
performed manually through reference lists of review
articles and relevant studies. The Methods, Results, and

81
82 Cleft Palate–Craniofacial Journal, July 2015, Vol. 52 No. 4
FIGURE 1 Schematic of the Pittsburgh Fistula Classification System.
* Reprinted with permission from The Cleft Palate–Craniofacial
Journal. Smith DM, Vecchione L, Jiang S, Ford M, Deleyiannis FW,
Haralam MA, Naran S, Worrall CI, Dudas JR, Afifi AM, et al. The
Pittsburgh Fistula Classification System: a standardized scheme for the
description of palatal fistulas. Cleft Palate Craniofac J. 2007;44:590–
594. doi:10.1597/06-204.1.
Conclusions sections of each article were reviewed in
detail to evaluate for relevance.
Study Eligibility Criteria
Inclusion criteria included (1) primary cleft repair; (2)
average or median age at time of surgery of ,4 years;
(3) postoperative follow-up period of .3 months; (4) a
description of an ONF as a failure of healing or a
breakdown of the primary surgical repair of palate
(Muzaffar et al., 2001); and (5) the number of fistulae
must have been reported. Exclusion criteria included (1)
preclinical animal studies; (2) case reports; (3) patients
with a type V through type VII fistula, as defined by the
Pittsburgh Fistula Classification System (Fig. 1); (4)
repair of submucous cleft palates; and (5) case series of
‘‘wide’’ cleft palate repairs. These criteria are outlined in
Table 1.
Outcome Measures
The primary outcome targeted for analysis was ONF
formation following primary cleft palate repair. For
subgroup analysis, a group of studies were analyzed
together if the definition of the ONF was described in
the report as a failure of healing or a breakdown of the
primary surgical repair of palate (Muzaffar et al., 2001).
For each selected article, data on number of subjects,
rate of ONF formation, study period, retrospective
versus prospective study, inclusion of syndromic chil-
dren, location of fistula, Veau classification of cleft, type
of surgery, whether decellularized dermis was used, and
follow-up times were collected.
TABLE 1 Inclusion and Exclusion Criteria Applied to Data
Collection
Inclusion Criteria Exclusion Criteria
Primary cleft palate repair Preclinical animal studies
Average/median age at surgery Case reports
,4 y
Postoperative follow-up .3 mo Patients with PFCS type V–VII
fistulae*
Number of fistulae reported in Submucous cleft palate repairs
article
(Anatomic definition of oronasal Case series of ‘‘wide’’ cleft palate
fistula) repairs
* PFCS ¼ Pittsburgh Fistula Classification System.
Statistical Analysis
A random effects meta-analysis of proportions and
exact confidence intervals was performed in Stata 11
(StataCorp. LP, College Station, TX). For Veau
classifications, an extension of the Cochran-Mantel-
Haenszel Test for a series of 2 3 4 tables was used in
SAS 9.3 (SAS Institute, Inc., Cary, NC).
The Cochran Q statistic was performed to determine
whether the selected articles were homogeneous enough
to be analyzed together in the meta-analysis. The
heterogeneity analysis is a chi-square test used to
evaluate the statistical significance of the heterogeneity
between studies, and a P value of less than 0.1 was
deemed to show heterogeneity. Heterogeneity was
further quantified by calculating I-squared, which is
the percentage of variability in the results due to
heterogeneity rather than sampling error or chance.
To further focus on a homogeneous subset of studies,
those with a fistula rate more than four standard
deviations away from the original meta-analysis pooled
estimate were excluded. A forest plot was used to
graphically represent effect sizes.
RESULTS
Between January 1, 2000, and October 1, 2012, there
were 70 research articles (of which 86.6% were
retrospective studies) that met the inclusion/exclusion
criteria (Table 1), with the exception that the authors of
these articles did not specifically describe their definition
of a fistula. A separate analysis is discussed below to
include only those that define an ONF as a failure of
healing or a breakdown of the primary surgical repair of
palate.
The 70 studies presented 12,410 patients with a fistula
rate of 6.9% (852 fistulae). The locations of the ONF,
based upon the Pittsburgh Fistula Classification System
(PFCS; Fig. 1), were as follows: uvular (type I), 0.0%;
soft palate (type II), 15.7%; soft palate-hard palate
junction (type III), 50.0%; and hard palate (type IV),
32.6%, with the remaining reported as a combination of
locations not otherwise specified. There was a signifi-
 Bykowski et al., RATE OF ORONASAL FISTULA FOLLOWING CLEFT PALATE SURGERY: A META-ANALYSIS 83

TABLE 2 Reported Incidence of Combined Oronasal Fistula

Rates of 12,410 Patients Separated by Surgical Technique

Surgical Technique Fistula Rate (%)

Furlow 6.6
Two-flap 5.1
Wardill-Kilner 12.5
von Langenbeck 11.5
Sommerland 14.3
Other 6.7

cant relationship between Veau classification and the

occurrence of an ONF (P , .001), with ONF most
prevalent in patients with a Veau IV cleft. The following
are the ONF rates for Veau I, II, III, and IV cleft
palates: 2.6%, 8.0%, 6.9%, and 9.1%, respectively. The
rate of fistula occurrence did not correlate with the
surgical technique used for palate repair (Table 2). One
study used decellularized dermis in cleft repair with a
fistula rate of 3.2% (Helling et al., 2006). Specifically,
the decellularized dermis was placed between the nasal
and oral closure layers at the soft palate-hard palate FIGURE 2 Flow diagram demonstrating inclusion and exclusion of
studies as well as the multiple levels of analysis.
junction.
Subgroup analysis was used to further analyze the
collected pool of data (Fig. 2). After evaluating the initial from the 17 studies. After excluding the six outliers, the data
70 studies, we excluded 53 studies because the definition of set comprised 11 studies (100% of the studies were
ONF was not outlined in the article. Of the remaining 17 retrospective reviews) and 2505 children. The final sub-
studies, six were then excluded because they had a group analysis contains only 20.2% of patients who were
detrimental effect on the homogeneity of studies (as included in the initial analysis of 70 research reports. These
described previously in the Statistical Analysis section); studies were found to be statistically comparable to each
they were eliminated because they were four standard other, meeting the homogeneity assumption with an
deviations from the original meta-analysis pooled estimate acceptable I-squared value of 25.3% and a nonsignificant

FIGURE 3 Forest plot for ‘‘weighted’’ oronasal fistula rates of the final 11 studies that were included in the meta-analysis.
84 Cleft Palate–Craniofacial Journal, July 2015, Vol. 52 No. 4
heterogeneity chi-square P value (P ¼ .203). The primary
outcome is the weighted rate of ONF formation, which we
found to be 4.9% (95% confidence interval [CI] 3.8 to
6.1%) in our meta-analysis (Fig. 3).
DISCUSSION
For decades, cleft surgeons have developed many
techniques spanning the reconstructive ladder to prevent
and address ONF formation following cleft palate repair.
Despite the effort spent addressing this problem, its
magnitude is unknown, with reported rates ranging from
0 to .60% (Cohen et al., 1991; Rohrich et al., 1996; Emory
et al., 1997; Muzaffar et al., 2001; Eberlinc and Kozelj,
2012; Mahoney et al., 2013). This wide range is of little
prognostic value and results, in part, from the lack of a
standardized definition of ONF. The goal of this meta-
analysis was to comprehensively evaluate the literature
using strict and specific inclusion/exclusion criteria to
determine the true incidence of ONF formation and to
identify risk factors that contribute to their development.
To our knowledge, this report is the first long-term meta-
analysis studying ONF rate and risk factors following
primary palatoplasty.
Limitations of the Literature
Comparative analysis is difficult due to the inconsis-
tency of reporting surgical outcome details, inclusion/
exclusion of submucous cleft palate repair, a wide range
of patient populations, and many surgical techniques
with modifications. Some groups report a fistula only if
it is ‘‘clinically significant’’ (Pigott et al., 2002; Inman et
al., 2005), which is inherently subjective. Our final
inclusion criteria excluded these studies so that only
studies that defined an ONF as a failure of healing or a
breakdown of the primary surgical repair of palate were
included. In a prior effort to standardize ONF, our
research group has previously published a classification
system based on anatomic location—the Pittsburgh
Fistula Classification System (Fig. 1) (Smith et al.,
2007).
In this meta-analysis, the inclusion/exclusion criteria
were used to evaluate children who underwent primary
cleft palate repair with adequate follow-up, with the
goal of determining fistula rate in the ‘‘typical’’ case (i.e.,
a routine cleft palate repair). As such, studies with
children who were on average older than 4 years old or
case series that specifically investigated children with
wide clefts were excluded. Bardach defined a wide cleft
palate as one in which the distance between the medial
edges of the hard palate is .1.5 cm (Bardach, 1999).
Multiple prior studies draw a link between palatal cleft
width and development of fistula (Helling et al., 2006;
Parwaz et al., 2009; de Agostino Biella Passos et al.,
2013); although, other studies exist that are not
consistent with this finding (Mahoney et al., 2013).
However, there is no consensus in the literature on what
defines a wide cleft. As such, we excluded any study that
stated specifically that they focused on wide clefts.
Our meta-analysis determined that the reported rate
of ONF formation following primary cleft palate repair
is 4.9% (95% CI, 3.8% to 6.1%). To allow our analysis
to be maximally useful to a large population of children
who undergo cleft palate repair, we used subgroup
analysis to evaluate the effect of potential risk factors on
ONF formation. In this regard, Veau classification
appears to modify risk for development of ONF.
Discrepancies exist that complicate surgical outcome
analysis following primary cleft palate repair. Because
there is wide variability in the reporting of such repair
(Eberlinc and Kozelj, 2012), a comprehensive analysis
must include subgroup analysis. Inclusion of fistulae
that are intentionally not repaired at the time of
palatoplasty—specifically, lingual-alveolar and/or la-
bial-alveolar fistulae (PFCS types VI and VII)—can be
misleading. Rather, more clinically interesting are true
ONF that represent surgical failure. Our goal was to
conduct a more clinically relevant analysis by exclud-
ing PFCS types V, VI, and VII fistulae (junction of
primary and secondary palate, lingual-alveolar, and
labial-alveolar, respectively). The PFCS type I fistulae
(uvular) are often not repaired because they do not
seem to cause dyslalia, hypernasal resonance, or nasal
air emission.
Some studies (Schultz, 1986; Muzaffar et al., 2001;
Losee et al., 2008) included only patients with ‘‘clinically
significant’’ ONF; whereas, others did not specify the
clinical significance (Cohen et al., 1991; Brusati and
Mannucci, 1994; Wilhelmi et al., 2001; Sommerlad,
2003; Inman et al., 2005). Phua and de Chalain (2008)
and Emory et al. (1997) included only palate fistulae
posterior of the incisive foramen.
Due to a retrospective nature and incomplete
medical records, some studies report their fistula rate
while appropriately noting that they were unable to
determine whether some fistulae were deliberately left
open (Phua and de Chalain, 2008). In fact, most studies
(87% to 100%, depending of level of exclusion) in this
meta-analysis were retrospective and, thus, vulnerable
to the inherent biases associated with a retrospective
review.
First Level of Analysis
Our first level of analysis included 12,410 patients;
however, many of these reports lack the details
(including how they defined a fistula) necessary for
critical evaluation and comparison. Nonetheless, even
though some details are missing, evaluation of this large
cohort is useful.
 Bykowski et al., RATE OF ORONASAL FISTULA FOLLOWING CLEFT PALATE SURGERY: A META-ANALYSIS
Consistent with several other papers (Amaratunga,
1988; Moore et al., 1988; Rohrich et al., 1996; Landheer
et al., 2010), half of the ONF that were reported
occurred at the soft palate-hard palate junction (PFCS
type III)—notably, a dynamic area that is often closed
under tension. Accordingly, surgeons have developed
techniques in attempts to ensure soft tissue closure and
prevent breakdown, including hamulus fracture, wide
relaxing incisions, and, even more aggressive, buccal
flaps or microvascular free flaps (Zemann et al., 2011;
Christiano et al., 2012). Furthermore, our group has
successfully instituted placement of acellular dermal
matrix (ADM) prophylactically during primary cleft
repair with fistula rate of 0.76% (Losee et al., 2008).
Although sufficient prospective studies do not exist,
ADM may decrease ONF formation when placed at the
soft palate-hard palate junction (PFCS type III) (Clark
et al., 2003; Cole et al., 2006; Helling et al., 2006;
Kirschner et al., 2006; Steele and Seagle, 2006).
Although many studies and case series of primary
cleft palate repair have been reported, the primary aim
of many of these studies was not to assess fistula rates.
For this reason, it is not surprising that critical
evaluation of the studies had to be further analyzed
and many studies excluded. After analyzing the 12,410
patients, we then excluded all of the studies that did not
specifically define an ONF as a failure of healing or a
breakdown of the primary surgical repair of palate.
Coincidentally, despite applying these exclusion criteria,
the fistula rate was similar at 6.4%. Subsequently, the
remaining 17 papers were analyzed. Six of these papers
were considered outliers. Finally, the fistula rate of the
11 papers (2,505 patients) was noted to be 4.9% (95%
CI, 3.8% to 6.1%), which again is similar to the rate of
the 12,410 patients.
Predictive Risk Factors
Our analysis also demonstrates that the rate of ONF
varies with the type of cleft. Corroborating other
studies, we found that the ONF rate was highest for
Veau type IV clefts (Cohen et al., 1991; Muzaffar et al.,
2001; Andersson et al., 2008; Parwaz et al., 2009;
Eberlinc and Kozelj, 2012). The rate of Veau IV clefts
was 9.1% in our analysis, which is similar to those of
other groups (Phua and de Chalain, 2008; Eberlinc and
Kozelj, 2012). Intuition tells us that the more severe the
cleft, the more technically challenging the reconstruction
and the higher the chance of ONF formation. Several
groups report that there is an association between the
extent of clefting and the fistula rate (Amaratunga,
1988; Cohen et al., 1991; Rohrich et al., 1996; Muzaffar
et al., 2001; Eberlinc and Kozelj, 2012; de Agostino
Biella Passos et al., 2013). We find it interesting that
there is a small study reporting that not only is the width
of the cleft important, but the ratio of cleft width to the
85
posterior arch width is a predictor of ONF formation
(Parwaz et al., 2009).
Surgical Technique
Many surgical techniques and modifications exist to
reconstruct the cleft palate, but there are some basic
techniques that are widely used. When evaluating 12,410
patients, we found differences in the aggregate raw data
comparing rate of ONF occurrence across surgical
techniques (Table 2). Although it is interesting to
evaluate these aggregate raw data, applying meta-
analysis statistical method is inappropriate. There are
many confounding factors (e.g., operating surgeon,
study population, modifications to procedure) that can
potentially impact ONF rate. Our data demonstrate
fistula rates vary only slightly among the techniques
widely used for primary repair of cleft palate. Nonethe-
less, previous reports have described a high ONF rate
following von Langenbeck palatoplasty compared with
Veau palatoplasty (Amaratunga, 1988). Schultz (1986),
however, found no correlation between the type of
palatoplasty and the rate of ONF occurrence. We
classified only primary surgical techniques (Table 2).
Many surgeons have their own modification. For
example, Bindingnavele et al. (2008) studied results
when the Furlow double-opposing Z-plasty was per-
formed with or without greater palatine flap mobiliza-
tion and islandization. Although these are different
procedures, two different surgeons may refer to each as
a Furlow palatoplasty. However, Bindingnavele et al.
(2008) found that there was a statistically significant
difference in fistula formation between the two modifi-
cations of the ‘‘same procedure.’’ Of course, this
complicates analysis of ONF formation among sur-
geons.
Study Limitations
A meta-analysis is a powerful tool to combine
studies—typically randomized controlled trials—to gen-
erate an integrated cohort of patients under similar
experimental or observational conditions. However,
randomized controlled trials are largely impractical in
plastic surgery outcomes research. Instead, the plastic
surgery literature comprises individual and institutional
case series.
Despite the utility of a meta-analysis, there are
drawbacks, such as the inherent publication biases
associated with each report that composes the meta-
analysis. Of course, there is variability among the
studies included in a meta-analysis, such as which
patient factors are reported from each study. For
example, some studies in this meta-analysis included
children with syndromes associated with clefts, others
did not, and others did not comment.
86 Cleft Palate–Craniofacial Journal, July 2015, Vol. 52 No. 4
Not every visible ONF causes dysfunction and thus
some do not require surgical repair. To the patient, the
most important measure is whether the fistula is
symptomatic. Unfortunately, few studies report this
information, and again, there is no standardized way to
objectively report palatal dysfunction. It is for this
reason that our meta-analysis focused on studies that
defined an ONF as an anatomic entity rather than a
functional one. Despite being an objective assessment,
defining an ONF strictly by anatomical measures can be
misleading because not all fistulae are clinically signif-
icant.
The nature of a meta-analysis precludes conclusions
of causality and only allows us to draw associations.
Although the goal is to combine similar studies to
increase the sample size, there are inherent biases and
confounding factors in a meta-analysis. For example,
there is the possibility that some patients who developed
an ONF did not follow up with the same surgeon.
Because there was no randomization process in the
individual studies, there is potential for multiple
unidentified confounders. Common shortcomings of
case series (e.g., potential loss of follow-up, publication
bias, and outcome reporting bias) can be functionally
amplified when these studies are analyzed together. A
large, multicenter, randomized trial is necessary but
challenging in cleft palate surgery.
CONCLUSIONS
Many studies have been conducted assessing ONF
formation following cleft palate repair. Most of these
studies were small, underpowered, and the clinical
experience of one author. Therefore, we conducted the
first long-term, comprehensive systematic review and
meta-analysis to evaluate the rate and risk factors for
ONF formation. Consistency of classifying ONF is
imperative to appropriately assess surgical outcomes,
which allows meaningful comparisons, and ultimately
leads to improving treatment strategies and providing
families with a more thorough informed surgical
consent. We offer a cohesive group of data to which
practitioners can refer when preoperatively counseling
caregivers of children undergoing palatoplasty.
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