YIJOM-3519; No of Pages 6

Int. J. Oral Maxillofac. Surg. 2016; xxx: xxx–xxx

http://dx.doi.org/10.1016/j.ijom.2016.09.019, available online at http://www.sciencedirect.com

Clinical Paper
Cleft Lip and Palate

Cleft relapse and oronasal F. Li, H.-T. Wang, Y.-Y. Chen,

W.-L. Wu, J.-Y. Liu, J.-S. Hao,
D.-Y. Luo

fistula after Furlow palatoplasty Guangzhou Women and Children’s Medical

Centre, Guangzhou 510623, Guangdong
Province, China

in infants with cleft palate:

incidence and risk factors
F. Li, H.-T. Wang, Y.-Y. Chen, W.-L. Wu, J.-Y. Liu, J.-S. Hao, D.-Y. Luo: Cleft relapse
and oronasal fistula after Furlow palatoplasty in infants with cleft palate: incidence
and risk factors. Int. J. Oral Maxillofac. Surg. 2016; xxx: xxx–xxx. # 2016
International Association of Oral and Maxillofacial Surgeons. Published by Elsevier
Ltd. All rights reserved.

Abstract. This study was performed to investigate the incidence of and risk factors for
postoperative cleft relapse and oronasal fistula after Furlow palatoplasty in infants.
Sixty-two infants with cleft palate, aged 6–12 months (mean 8.25 months), who
underwent cleft repair by Furlow double opposing Z-plasty between March 2012
and August 2014, were enrolled in the study. Risk factors for postoperative cleft
relapse and oronasal fistula after Furlow palatoplasty were identified by logistic
regression analysis. The incidence rates of cleft relapse at 1 week and oronasal
fistula at 3 months after surgery were 24.2% (15/62) and 9.7% (6/62), respectively.
Among all of the variables screened, only the width of the cleft was significantly
associated with the incidence of postoperative cleft relapse (P = 0.001) and oronasal
fistula (P = 0.011); the incidence rates were positively correlated with the width of
the cleft when it exceeded 6.8 mm and 7.5 mm, respectively. Based on these
findings, in order to reduce the incidence of postoperative cleft relapse and oronasal
fistula, Furlow repair is not recommended for patients with wide clefts. An Key words: cleft palate; cleft relapse; fistula;
appropriate angle between the Z-flap incision and the central axis, use of a bilateral infant; furlow palatoplasty.
relaxation incision, and postoperative nursing care can help reduce the incidence of
postoperative cleft relapse. Accepted for publication 21 September 2016

Cleft palate is the second most common
human birth defect, and it poses a great
physiological and social challenge to af-
fected patients. A wide range of surgical
procedures have been described for the
repair of cleft palate.1 However, none has
proved to be superior to the others or is
suitable for all patients, and a standard
protocol is still lacking.2 Among the many
palatoplasties, the Furlow double opposing
Z-plasty (also known as the Furlow pala-
toplasty), which is based on the geometric
principle of ‘Z’ operation, can both fully
extend the length of the soft palate and
reconstruct the palatal muscles to narrow
the pharyngeal cavity, which is beneficial
for the recovery of palatopharyngeal clo-
sure function.3,4 It has been reported that

0901-5027/000001+06 # 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Li F, et al. Cleft relapse and oronasal fistula after Furlow palatoplasty in infants with cleft palate:
incidence and risk factors, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.09.019
YIJOM-3519; No of Pages 6
2 Li et al.
patients treated with the Furlow palato-
plasty can achieve 90% of palatopharyn-
geal closure function, which is higher than
that achieved with other procedures, like
the von Langenbeck procedure, one-flap
push-back palatoplasty, and the Sommer-
lad procedure.2,3,5,6 Since 2002, the Furlow
palatoplasty has become one of the most
commonly used procedures for palate re-
pair.7
Oronasal fistula is the most common
complication after palatoplasty.8 Most
commonly, sutures within the oral mu-
cosa fall off at 1 week after surgery,
leaving a local fissure at the surgical site
in the oral cavity. The present authors
term the resultant fissure ‘cleft relapse’.
The local fissure either eventually heals
well after proper treatment or develops
into a channel between the oral and nasal
cavity, which is called an oronasal fistu-
la.9 An oronasal fistula can result in nasal
leak, dysarthria, hearing impairment,
food reflux, and maxillary hypoplasia,
greatly harming and inconveniencing
the patient.9,10 Oronasal fistula continues
to be a challenge for cleft surgeons, and
thus research-based guidelines for select-
ing the optimal techniques or procedures
to decrease the rate of fistula are impor-
tant.
The Furlow palatoplasty is associated
with a lower incidence of oronasal fistula
(5.6–10%) compared with other palato-
plasty procedures such as the von Langen-
beck procedure (22%) and one-flap push-
back palatoplasty (43%);11,12 however,
the incidence is still high in cases of wide
clefts.13 Given that the occurrence of pal-
atal fistula might be related to multiple
factors, such as high tension in the local
sutures, infection, injury, haematoma, and
tissue necrosis,10 identifying the risk fac-
tors for the development of an oronasal
fistula after Furlow palatoplasty is of great
significance in terms of optimizing the
indications for this widely accepted pro-
cedure.
Several studies have reported the inci-
dence rates of cleft relapse and
oronasal fistula after other palatoplasty
procedures,13–15 but there are relatively
few reports on the incidence of postop-
erative cleft relapse and oronasal
fistula after Furlow palatoplasty in
infants.
Considering that palatoplasties per-
formed at the infant stage are conducive
to the normal development of phonetic
function,16 the present study aimed to
investigate the incidence of and risk
factors for cleft relapse and oronasal
fistula after Furlow double opposing
Z-plasty in infants with cleft palate.
Please cite this article in press as: Li F, et al. Cleft relapse and oronasal fistula after Furlow palatoplasty in infants with cleft palate:
incidence and risk factors, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.09.019
Materials and methods
Patients
This study consisted of an evaluation of
all cleft palate patients treated at the
authors’ centre from March 2012 to Au-
gust 2014. The inclusion criteria were (1)
age between 6 and 12 months; (2) com-
plete or incomplete cleft palate, includ-
ing cleft soft and hard palate (CSHP),
cleft soft palate (CSP), and unilateral
cleft lip and palate (UCLP); (3) no upper
respiratory or gastrointestinal infection;
and (4) ability to attend for regular fol-
low-up. Exclusion criteria were patients
with syndromic cleft palate, such as those
with Pierre Robin syndrome, congenital
velopharyngeal insufficiency, and sub-
mucous cleft palate. Informed consent
was obtained from the guardian of each
infant, and the study protocol was ap-
proved by the ethics committee of the
study centre. Fig. 1. Schematic diagram of the incision
design. The pink areas indicate fistulae of
types I–V (from bottom to top), respectively:
Surgical procedure
type I, bifid uvula; type II, soft palate; type III,
The Furlow double opposing Z-plasty junction of the soft and hard palates; type IV,
was performed as described previously.3 hard palate; type V, junction of the primary
and secondary palates. (For interpretation of
The key point of the Furlow palatoplasty
the references to color in this figure legend,
is to design two opposing Z flaps beside the reader is referred to the web version of the
the cleft, forming a musculomucosal flap article.)
with a posterior pedicle and a mucosal
flap with an anterior pedicle both in
the oral and nasal cavities in the soft
palate area (Fig. 1). First, the two arms
of the Z-flap in the oral cavity are dis- Postoperative follow-up
sected within the mucosa. Then the edges
of the cleft are cut open and the palatine After surgery, treatments including local
muscle is cut off at the location of its debridement, regular flushing, and wet
attachment, forming a triangular flap dressing were given, as well as a pre-
with the posterior pedicle. Next, on the scription for mouthwash. All of the chil-
other side of the cleft, the mucosa is dren were observed until day 3 after
stripped at the superficial layer of the surgery. The children were discharged
palatine muscle, forming a mucosal flap once it was confirmed that they had no
with an anterior pedicle. Thus, the Z-flap abnormal routine blood test results and
in the oral cavity is created. The Z-flap in no signs of surgical wound infection.
the nasal cavity is created following the Epidermal growth factor for local appli-
same steps. In the suture step, the flaps in cation was administered to promote
the nasal cavity are mutually diverted and wound healing.
sutured first, followed by the flaps in the All patients underwent physical exam-
oral cavity. inations at 1 week and 3 months after
For the patients in this study, the nasal surgery, in which the healing status of
mucosa was sutured with non-absorbable the incision and the presence and location
5–0 Vicryl sutures; interrupted suturing of cleft relapse or fistula were recorded.
with absorbable 5–0 sutures was applied On the basis of the Pittsburgh Fistula
to the oral mucosa. For the hard Classification System,17 palatal fistulae
palate portion, where a fistula can can be classified into seven types: I, bifid
easily develop, mattress sutures were uvula; II, soft palate; III, junction of the
adopted to avoid excessive involution soft and hard palate; IV, hard palate; V,
of the front part of the mucosa . All junction of the primary and secondary
of the procedures were performed by palates (for Veau IV clefts); VI, lingual
one surgeon (FL), who was skilled in alveolar; and VII, labial alveolar. The
this technique before the study was per- fistulae seen in the present study were of
formed. types I–V (Fig. 1).
YIJOM-3519; No of Pages 6

Cleft relapse after Furlow palatoplasty 3

Data collection
Demographic and clinical data including
sex, age (months), type of cleft palate
(UCLP vs. CSP vs. CSHP), length of the
soft palate (the distance from the mid-
point of the posterior margin of the hard
palate to the root of the uvula), width of
the soft palate (the distance between the
midpoints of the bilateral pterygoman-
dibular ligaments), width of the hard
palate (the distance between the most
protruding parts of the alveolar ridge in
the bilateral molar regions of the hard
palate), length of the cleft (from the
anterior limit of the cleft to the midpoint
of the transverse line connecting the two
uvulae), and width of the cleft (measured
at the junction of the hard and soft
palates) were collected to identify risk
factors for the development of postoper-
ative cleft relapse and fistula.
Statistical analysis
All statistical analyses were performed
using SPSS version 17.0 software (SPSS
Inc., Chicago, IL, USA). Univariate anal-
ysis was initially used to select possible
variables, and multiple logistic regression
analysis was then used to identify the
independent factors. The receiver operat-
ing characteristic (ROC) curves of the
identified risk factor(s) were plotted to
calculate the area under the curve
(AUC). P < 0.05 was considered statisti-
cally significant.
Results
Patient characteristics
Sixty-two infants (35 male and 27 female)
aged 6–12 months (mean 8.3 months) with
non-syndromic cleft palate were treated by
Furlow double opposing Z-plasty in the
study. Among them, 24 had CSHP, 14 had
a CSP, and 24 had a UCLP.
Incidence of cleft relapse and oronasal
fistula
At 1 week after surgery, 24.2% (15/62) of
the cases were found to have an oral ulcer,
suture falling off, or cleft relapse. At 3
months after surgery, only 9.7% (6/62) of
the patients had an oronasal fistula.
Location of cleft relapse and oronasal
fistula
As shown in Table 1, nine of the 15
(60.0%) relapses at 1 week after surgery
were found at the junction of the hard and
soft palates, of which six had occurred at
the tip of the left triangular flap.
At 3 months after surgery, only two
relapses occurring at the junction of the
soft and hard palates developed into oro-
nasal fistulae, with a recovery rate of
77.8%. Other relapses were found at the
hard palate (4/15) and the junction of the
primary and secondary palates (2/15), and
the recovery rates for these relapses were
50.0% and 0.0%, respectively.
Risk factors for cleft relapse and
oronasal fistula
Univariate analysis showed that the type
of cleft, length of the cleft, and width of
the cleft differed significantly between
those who experienced relapse and those
who did not (P = 0.031, 0.013, and 0.000,
respectively). Only the width of the cleft
still showed strong significance on multi-
variate analysis (P = 0.001; Table 2). For
oronasal fistula, the type of cleft and width
of the cleft showed significant differences
on univariate analysis (P = 0.038 and
0.006, respectively). As was the case for
cleft relapse, only the width of the cleft
was identified as an independent risk fac-
tor for oronasal fistula on multivariate
analysis (P = 0.011; Table 3).
The AUCs of the ROC curves for cleft
relapse and oronasal fistula were 0.843
(P = 0.000) and 0.869 (P = 0.003), re-
spectively. The relationships between
the width of the cleft and the incidences
of postoperative relapse and fistula are
shown in scatter plots in Fig. 2; the
incidence rates of relapse (P = 0.000)
and fistula (P = 0.011) were positively
correlated with the width of the cleft
when it exceeded 6.8 mm and 7.5 mm,
respectively.
Discussion
In modern medicine, the goal of palato-
plasty has shifted from simply closing the
cleft to recover the normal appearance and
sucking function, to a greater emphasis on
the palatopharyngeal closure function.
Compared with other palatoplasty proce-
dures, the Furlow palatoplasty, which has
the advantages of lengthening the soft
palate and realigning the palatal muscula-
ture,3–6,18 is associated with better devel-
opment of velopharyngeal function and a
lower incidence of palatal fistula,11,12 one
of the most common, troublesome com-
plications of palatoplasty. In the present
study, the incidence rate of fistula was
9.7%, which is roughly consistent with
rates reported in previous studies,11,12
but lower than that observed for the Bar-
dach two-flap palatoplasty (17.4%, 12/69)
(authors’ unpublished data).
Previous studies have found that high
tension in the local sutures may contribute
to the development of a fistula.10 In this
regard, several details of the Furlow pro-
cedure should be stressed. The angle be-
tween the Z-flap incision and the central
axis is crucial in surgery design, because it
determines the extension length and ten-
sion of the soft palate. Furlow himself
thought that an angle of 608 could extend
the soft palate furthest.3 However, Deng
et al. recommended that the angle should
be between 608 and 708, which could
contribute to reducing the suture
tension and effectively reconstructing

Table 1. Postoperative oronasal fistula at different locations.

Number of patients with fistula (n) Rate (n/N)a
Location Recovery rate (100.0%–n2/n1)b
1 week PO (n1) 3 months PO (n2) 1 week PO 3 months PO
Bifid uvula 0 0 0 0 –
Soft palate 0 0 0 0 –
Junction of soft and hard 9 2 60.0% 33.3% 77.8%
palates
Hard palate 4 2 26.7% 33.3% 50.0%
Junction of primary and 2 2 13.3% 33.3% 0.0%
secondary palates
PO, postoperative.
a
n: The number of patients with fistula; N: The total number of patients included.
b
n1: The number of patients with fistula at 1 week after surgery; n2: The number of patients with fistula at 3 months after surgery.

Please cite this article in press as: Li F, et al. Cleft relapse and oronasal fistula after Furlow palatoplasty in infants with cleft palate:
incidence and risk factors, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.09.019
YIJOM-3519; No of Pages 6

4 Li et al.

Table 2. Logistic regression analysis of possible risk factors for cleft relapse after the Furlow procedure.
Healing condition at 1
week after procedure Univariate Multivariate analysis AUC analysis
Variable analysis
Wald 95% 95%
Normal Relapse P-value b SE x2 P-value OR CI AUC SE P-value CI
Sex 0.359
Male 25 10
Female 22 5
Age (months) 8.1  2.2 8.9  1.8 0.209
Type of cleft 0.031*
UCLP 14 10 0.307
CSP 13 1 0.239
CSHP 20 4 0.883
Length of 15.7  2.3 17.5  3.1 0.017* 0.615
soft palate
Width of 29.0  4.3 29.7  4.4 0.580
soft palate
Width of 35.4  2.55 36.0  2.54 0.462
hard palate
Length of cleft 18.7  3.7 21.9  5.7 0.013* 0.063
Width of cleft 6.9  2.6 10.0  1.8 0.000* 0.759 0.230 10.835 0.001* 2.135 1.359– 0.843 0.052 0.000* 0.741–
3.354 0.944
AUC, area under the curve; SE, standard error; OR, odds ratio; CI, confidence interval; UCLP, unilateral cleft lip and palate; CSP, cleft soft palate;
CSHP, cleft soft and hard palate.
*
Significant difference.

Table 3. Logistic regression analysis of possible risk factors for oronasal fistula after the Furlow procedure.
Healing condition at 3
months after procedure Univariate Multivariate analysis AUC analysis
Variable analysis
Wald 95%
Normal Fistula P-value b SE x2 P-value OR CI AUC SE P-value 95% CI
Sex 0.689
Male 31 4
Female 25 2
Age (months) 8.2  2.2 8.8  1.8 0.493
Type of cleft 0.038*
UCLP 19 5 0.310
CSP 14 0 0.165
CSHP 23 1 0.646
Length of 16.0  2.5 17.5  3.4 0.174
soft palate
Width of 29.0  4.5 30.2  2.6 0.520
soft palate
Width of 35.7  2.6 34.5  1.9 0.277
hard palate
Length of 19.2  4.6 21.3  2.8 0.297
cleft
Width of 7.3  2.7 10.5  1.3 0.006* 0.675 0.265 6.481 0.011* 1.963 1.168– 0.869 0.056 0.003* 0.759–
cleft 3.300 0.979
AUC, area under the curve; SE, standard error; OR, odds ratio; CI, confidence interval; UCLP, unilateral cleft lip and palate; CSP, cleft soft palate;
CSHP, cleft soft and hard palate.
*
Significant difference.

the anatomic structure of the palatal mus-
cle.19 In the present authors’ experience,
the ideal angle between the Z-flap incision
and the central axis is between 608 and
708, which is consistent with the conclu-
sion of Deng et al. In addition, the distance
between the ends of the Z-flap incision and
the internal side of the bilateral pterygoid
hamuli was about 3 mm, which better
avoids injury to the levator veli palatini
and ascending palatine artery.
In traditional palatoplasty procedures,
like the two-flap and Sommerlad methods,
a triangular wound in the nasal mucosa at
the junction of the soft and hard palates
may be difficult to suture and might need
to be covered with a biological membrane,
such as products made of dermal matrix.20
However, with the Furlow procedure, the
mucosa flap in the nasal cavity can be
sutured strictly by adjusting its direction,
because of this, the cleft in the nasal cavity
is tightly closed in most cases. Addition-
ally, relaxing incisions in the parapharyn-
geal mucoperiosteum can be made inside
the bilateral medial plates of the pterygoid
process to fully relax the nasal mucosa and
reduce the suture tension in the nasal
cavity.
Cleft relapse is an initial event in the
development of oronasal fistula, but does
not invariably cause oronasal fistula, be-
cause of the design features of the Furlow

Please cite this article in press as: Li F, et al. Cleft relapse and oronasal fistula after Furlow palatoplasty in infants with cleft palate:
incidence and risk factors, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.09.019
YIJOM-3519; No of Pages 6
Fig. 2. Relationships between the cleft width and the incidence rates of postoperative relapse
and fistula. The line of fit was determined by the data points for incidence rates greater than 0%.
The incidences of postoperative relapse and fistula were positively correlated with the cleft
width when it exceeded 6.8 mm and 7.5 mm, respectively.
procedure, transposition suturing was per-
formed with a left-sided musculomucosal
flap in the oral soft palate mucosa, and
suture tension could be reduced through
submucosal muscle suturing. In contrast,
due to the thinner mucosa in transposition
suturing with a right-sided musculomuco-
sal flap, improper design of the rotation
angle or wide midline horizontal displace-
ment (i.e., wide cleft) tends to result in
poor tissue toughness and postoperative
recurrence. In the present study, all cases
of relapse occurred in the oral mucosa, and
most were located at the junction of the
hard and soft palates, with the tips of the
left triangular flap (mucosa-only flap)
most frequently involved. However,
77.8% of the cases of relapse in this loca-
tion eventually healed without forming an
oronasal fistula. This may be because the
opposing Z-style sutures made the inci-
sions between the oral and nasal mucosa
not coincident in the vertical plane. As a
result, fissures in the oral mucosa may not
develop into oronasal fistulae, but rather
be covered by local scar formation after
proper treatment. In the Furlow procedure,
the levator veli palatini converges at the
root of the uvula after horizontal retro-
positioning, where the local suture tension
is rather high.3 However, according to the
results of this study, fistulae are rare in this
location, as long as the muscles are sutured
accurately.
Please cite this article in press as: Li F, et al. Cleft relapse and oronasal fistula after Furlow palatoplasty in infants with cleft palate:
incidence and risk factors, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.09.019
Cleft relapse after Furlow palatoplasty
The foundation of the Furlow procedure
is the use of the lateral length to remedy a
deficiency in longitudinal length. The
authors have found in clinical practice that
if the bilateral soft palate beside the cleft is
narrow and the central cleft is wide, the tips
of the Z flaps can undergo high lateral
tension, which will result in poor healing.
In the present study, cleft width was iden-
tified as the only risk factor for the devel-
opment of postoperative fistula, and the
incidence of fistula was significantly corre-
lated with the cleft width. This finding is
similar to that observed in a previous
study.21 Therefore, patients with a cleft that
is excessively wide or those who have an
insufficient ratio of width of the bilateral
soft palate to cleft length are not suitable
candidates for a Furlow palatoplasty. For
patients with narrower clefts, a Furlow
repair is recommended; otherwise, the Bar-
dach two-flap palatoplasty is preferred.20
In addition, a bilateral relaxation inci-
sion approach was adopted in all patients
in the present study. The authors have
found that a relaxation incision has a
positive role in fully relaxing the muco-
periosteal flap and reducing the midline
horizontal displacement.
A previous study emphasized the im-
portance of nursing care in achieving a
good clinical outcome from cleft palate
surgery in paediatric patients.12 The find-
ing of the present study that many cases of
5
cleft relapse recovered without an orona-
sal fistula forming further emphasizes the
importance of postoperative nursing care.
To prevent the development of postopera-
tive cleft relapse and fistula caused by
incision erosions, the infant patients were
required to adhere to the following
instructions for at least 3 weeks: (1) re-
ceive a liquid diet; (2) avoid the sucking
action (training at spoon feeding was en-
couraged 2 weeks before surgery) and
remove residual milk with water after
feeding; and (3) maintain oral hygiene.
Also, if the incision did not heal well,
effective local treatments were to be given
immediately. For example, 3 days after
surgery, one of the patients showed severe
mucosal congestion and erosion at the
junction of the soft and hard palates in
the oral cavity, and a purulent secretion
could be seen in the nasal cavity. One
week after surgery, the sutures in the nasal
mucosa fell off, leaving a canal between
the oral and nasal cavities; the presence of
this canal was confirmed by the outflow of
milk from the nose during a meal. Local
treatments including regular flushing, wet
dressing, and anti-infection drugs were
given immediately and continuously.
Three months later, the local wound was
well covered by scar formation, and no
fistula was found. However, delayed heal-
ing of the local mucosa will have a nega-
tive impact on the motion ability of the
soft palate, affecting the subsequent velo-
pharyngeal function.
This study has several limitations. First,
only 62 patients were included, and be-
cause of this small sample size, the study
may be underpowered. Second, only a few
possible risk factors were included in the
analysis due to the unavailability of data
for other factors. As mentioned above,
many other factors, such as high tension
in the local sutures, infection, injury, hae-
matoma, and tissue necrosis, may also
contribute to the development of an oro-
nasal fistula.10 Future studies should be
conducted to carefully address these
issues.
In conclusion, cleft width was identified
as the only risk factor for the development
of cleft relapse and oronasal fistula after
Furlow double opposing Z-plasty in
infants with cleft palate. For clefts exceed-
ing 7.5 mm in width, the possibility of
postoperative fistula increased significant-
ly along with the increase in cleft width.
Thus, the Furlow repair is recommended
only for patients with narrower clefts.
Funding
None declared.
YIJOM-3519; No of Pages 6
6 Li et al.
Competing interests
None declared.
Ethical approval
Guangzhou Children and Women’s Med-
ical Centre.
Patient consent
Not required.
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Address:
Hong-Tao Wang
Guangzhou Women and Children’s Medical
Centre
Guangzhou 510623
Guangdong Province
China
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