CLINICAL STUDY
Analysis of Complications in Primary Cleft Lips
and Palates Surgery
Zhaoqiang Zhang, DDS,* Silian Fang, DDS, PhD,* Qingbin Zhang, DDS, PhD, Lei Chen, MD, PhD,
Yarui Liu, MD, Kefeng Li, PhD,|| and Yan Zhao, MD
Introduction: A series of retrospectively recorded patients with
cleft lip and palate was uniquely investigated to demonstrate and an-
alyze the complications after cleft repairing operations in a selected
Chinese population.
Material and Methods: From January 2005 to January 2012, a se-
lected group of 2100 patients with cleft lip and/or palate who have
complete records were chosen from a large sample in the units.
Complete data were retrieved, including sex, age, clinical classifica-
tion, surgical modality, complications, and follow-up results. The
complications were classified into 2 categories: early and long-
term complications. After surgery, most patients with cleft lip
remained in the hospital for 7 days and cleft palate repairs for
10 days. A standard regimen of antibiotics was administered for
3 to 5 days clinically.
Results: Of the 2100 patients, there were 1360 males and 760
females who had congenital cleft deformity with complete clinical
records in the department of oral and maxillofacial surgery. The
age distribution was as follows: 1600 patients in the group of
3 months to 2 years, 320 patients in the group of 2 to 10 years,
130 patients in the group of 11 to 19 years, and 50 patients in the
group of older than 20 years. As to the treatment modality, cleft lips
were repaired by rotation advancement method with various minor
modifications or Tennison modality. The cleft palates were closed
using the von Langenbeck, Veau/Wardill/Kilner, or Furlow tech-
nique. The overall complication rate was 16.8% of the patients. Of
the early complications, there were 6 cases of asphyxia, 17 cases
of pyrexia, 5 cases of edema of the respiratory tract, 8 cases of upper
respiratory tract infection, 6 cases of bronchiolitis, 7 cases of
From the *Department of Stomatology, The Sixth Affiliated Hospital of Sun
Yat-Sen University; Department of Oral and Maxillofacial Surgery, School
and Hospital of Stomatology, Guangzhou Medical University; Department
of Burns Surgery, the First Affiliated Hospital, Sun Yat-sen University;
Department of Pediatric Dentistry, School and Hospital of Stomatology,
Guangzhou Medical University, Guangzhou, Guangdong, China; ||Depart-
ment of Medicine, School of Medicine, University of California, San
Diego, California; and Department of Head and Neck Surgery, The Fourth
General Hospital, Hebei Medical University, Shijiazhuang City, Hebei
Province, China.
Received April 8, 2013.
Accepted for publication January 31, 2014.
Address correspondence and reprint requests to Qingbin Zhang, DDS, PhD,
Department of Oral and Maxillofacial Surgery, School and Hospital of
Stomatology, Guangzhou Medical University, 39 Huangsha Rd, Liwan
District, Guangzhou City, Guangdong Province, 510140, China; E-mail:
qingbinandzhaoqiang@hotmail.com
The authors report no conflicts of interest.
Authors Zhang and Fang contributed equally to the article.
Copyright 2014 by Mutaz B. Habal, MD
ISSN: 1049-2275
DOI: 10.1097/SCS.0000000000000832
968 The Journal of Craniofacial Surgery Volume 25, Number 3, May 2014
Copyright 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
pneumonia, 9 cases of diarrhea and vomiting, 6 cases of hemor-
rhage, 5 patients of odontoptosis, 11 cases of erosion of the corner
of mouth, 5 cases of drowsiness, 11 cases of incision dehiscence,
9 cases of wound infection, 6 cases of palatal dehiscence/fistula,
3 cases of nostril floor breakdown, 7 cases of conjunctivitis, as well
as 3 cases of mortality. The long-term complications included
30 cases of secondary lip/nasal deformity, 10 cases of dehiscence
of lip, 14 cases of palatal fistula/decencies, 18 cases of hearing
problem/otitis media, 21 cases of poor ventilation/snoring, 66 cases
of velopharyngeal incompetence, and 58 cases of voice disorder.
Conclusions: Complications after cleft surgery are unavoidable
clinically. More attention should be paid to the etiologic factors to
minimize the prevalence of complications. Mortality can be found
in patients with cleft, which is a deadly complication. Problems of
respiratory tract and hemorrhage should be emphasized and treated
seriously.
Key Words: Cleft lip/palate, surgery, complications, morbidity,
mortality
(J Craniofac Surg 2014;25: 968971)
C left lip (cheiloschisis) and cleft palate (palatoschisis), which
can also occur together as cleft lip and palate, are variations
of a type of cleft congenital deformity caused by abnormal facial
development during gestation.1,2 A cleft is a fissure or opening, that
is, a gap. It is the nonfusion of the body's natural structures that
form before birth. Approximately 1 in 700 to 1000 children born
has a cleft lip, a cleft palate, or both.3 In decades past, the condition
was sometimes referred to as harelip, based on the similarity to the
cleft in the lip of a hare, but that term is now generally considered to
be offensive. Clefts can also affect other parts of the face, such as
the eyes, ears, nose, cheeks, and forehead. A cleft lip or palate
can be successfully treated with surgery, most especially if con-
ducted soon after birth or in early childhood.4,5
Previous research has shown that the initial surgical repair of
the cleft lip/palate does not always result in an acceptable out-
come.6,7 At times, neither the patients nor the surgeons tend to be
satisfied with the long-term results. Later in life, some patients re-
port dissatisfaction with their surgical outcomes, especially for the
nasolabial region and the profile, and many wish to have additional
secondary operations.7 Problems of respiratory tract, bleeding, in-
fection, and incision dehiscence have been reported in the litera-
ture.8 However, strictly speaking, there is a paucity of information
on the nature and incidence of the complications associated with
primary cleft lip and palate surgery to date. In particular, a detailed
and thorough analysis of complications after cleft surgery of a larger
sample has not been found. Only studies of complications in a small
sample have been reported previously. However, there is not any re-
port on this issue in the eastern country China.
The aim of this retrospective study was to investigate and an-
alyze the incidence of complications, etiologic factors, and measures
The Journal of Craniofacial Surgery Volume 25, Number 3, May 2014
to minimize them. This is the first study that reported the com-
plications of cleft surgery in such a large sample in this country.
PATIENTS AND METHODS
From January 2005 to January 2012, a selected group of
2100 patients with cleft lip or palate who have complete records
were chosen from a large sample in the units. Complete data were
retrieved, including sex, age, clinical classification, surgical modal-
ity, complications, follow-up results, and preventive measures. Pre-
operative evaluation of all patients was carried out to detect
associated congenital anomalies or comorbidities. Children with fe-
ver and/or history of recent respiratory tract infection as well as
other systemic surgical contraindications were excluded from the
study. The complications were classified into 2 categories: early
and long-term complications. After surgery, most patients with cleft
lip remained in the hospital for 7 days and cleft palate repairs for
10 days. A standard regimen of antibiotics was administered for
3 to 7 days according to clinical conditions. All patients were admit-
ted 2 days before the surgery. The operations have been performed
or supervised by the senior surgeons, and anesthesia was adminis-
tered or supervised by experienced pediatric anesthetist. A prophy-
lactic antibiotic treatment (ampicillin 50 mg/kg per day) was
routinely given with the induction of anesthesia. Paracetamol was
given for postoperative analgesia (15 mg/kg) according to nursing
assessment. Arm splints are routinely used for 1 week. The mean
hospital stay was 8 days for cleft lip surgery and 10 days for cleft
palate operations.
The 2 types of complication were defined as follows:
1. Early complications: it refers to the complications that occurred
within 2 weeks.
2. Long-term complications: it refers to the complications that
occurred beyond 2 weeks.
RESULTS
Of the 2100 patients, there were 1360 males and 760 females
who had congenital cleft deformity with complete clinical records
in the department of oral and maxillofacial surgery. The age distri-
bution was as follows: 1600 patients in the group of 3 months to
2 years, 320 patients in the group of 2 to 10 years, 130 patients in
the group of 11 to 19 years, and 50 patients in the group of older
than 20 years. The patients were classified according to the interna-
tional criteria (Fig. 1). As to the treatment modality, cleft lips were
repaired by rotation advancement with various minor modifications,
or Tennison modality (Fig. 2). The cleft palates were closed using
the von Langenbeck, Veau/Wardill/Kilner, and Furlow techniques
(Fig. 3). The overall complication rate was 16.8% of the patients.
Of the early complications, there were 6 cases of asphyxia, 17 cases
FIGURE 1. Types and distribution of patients with cleft in this collection. BCCP
indicates bilateral complete cleft palate; BICL, bilateral incomplete cleft lip;
BMCL, bilateral mixed cleft lip; ICP, incomplete cleft palate; UICL, unilateral
incomplete cleft lip.
2014 Mutaz B. Habal, MD
Copyright 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
Complications After Cleft/Palate Repair
FIGURE 2. Types and distribution of surgical modality for cleft lips. BCCL
indicates bilateral complete cleft lip; BICL, bilateral incomplete cleft lip; BMCL,
bilateral mixed cleft lip; UCCL, unilateral complete cleft lip; UICL, unilateral
incomplete cleft lip.
of pyrexia, 5 cases of edema of respiratory tract, 8 cases of upper
respiratory tract infection, 6 cases of bronchiolitis, 7 cases of pneumo-
nia, 9 cases of diarrhea and vomiting, 6 cases of hemorrhage, 5 cases
of odontoptosis, 11 cases of erosion of the corner of mouth, 5 cases
of drowsiness, 11 cases of incision dehiscence, 9 cases of wound infec-
tion, 6 cases of palatal dehiscence/fistula, 3 cases of nostril floor break-
down, 7 cases of conjunctivitis, as well as 3 cases of mortality (Fig. 4.).
The long-term complications included 30 cases of secondary lip/nasal
deformity, 10 cases of dehiscence of lip, 14 cases of palatal fistula/
decencies, 18 cases of hearing problem/otitis media, 21 cases of poor
ventilation/snoring, 66 cases of velopharyngeal incompetence, and
58 cases of voice disorders (Fig. 5).
DISCUSSION
Cleft lip and/or palate are common craniofacial abnormali-
ties with an incidence of approximately 1 in 700 to 1000 live
births.9,10 It is the second most common congenital anomaly of
the body after clubfoot and the most common congenital anomaly
of the head and neck with a predictable racial distribution.11 Cleft
may cause problems with feeding, ear disease, speech, and sociali-
zation.12 Most children who have their clefts repaired early enough
are able to have a happy youth and social life. Having a cleft palate/
lip does not inevitably lead to a psychosocial problem.13 However,
adolescents with cleft palate/lip are at an elevated risk for develop-
ing psychosocial problems especially those relating to self-concept,
peer relationships, and appearance.14,15 A cleft lip may require 1 or
2 operations depending on the extent of the repair needed. The ini-
tial surgery is usually performed by the time a baby is approxi-
mately 3 months old.16 Repair of a cleft palate often requires
multiple operations over the course of 18 years.17 The first surgery
to repair the palate usually occurs when the baby is between 6 and
12 months old. The initial surgery creates a functional palate,
reduces the chances that fluid will develop in the middle ears, and
aids in the proper development of the teeth and facial bones.18
FIGURE 3. Types and distribution of surgical modality for cleft palates. BCCP
indicates bilateral complete cleft palate; CSP, cleft of soft palate; ICP,
incomplete cleft palate; UCCP, unilateral complete cleft palate.
969
Zhang et al The Journal of Craniofacial Surgery Volume 25, Number 3, May 2014
FIGURE 4. Types and distribution of early complications after repairing surgery. A, Number. B, Percentage.
Children with a cleft palate may also need a bone graft when they
are approximately 8 years old to fill in the upper gum line so that
it can support permanent teeth and stabilize the upper jaw. Approx-
imately 20% of children with a cleft palate require further surgery to
help improve their speech.19
Regarding the surgical repairing, most would agree that the ul-
timate aim of cleft surgery is that the patients look well, feed well,
and speak well. To achieve these goals, much attention has been paid
in the literature to individual techniques of lip/palate repair, to the
clinical results of palate surgery, to the speech end products, and, oc-
casionally, to problems associated with the cleft operations.20 How-
ever, little, if any, attention has been paid to the study of mortality
and morbidity accompanying such surgery. There were not many
comprehensive analysis and investigations on such complications.
Thus, the authors attempted to determine the incidence of and the ap-
parent causative factors leading to the complications with cleft
operations. The complications were defined in this retrospective
study into 2 categories: early and long-term complications. Although
there are many publications about late complications of cleft surgery
according to different surgical techniques, few discuss the incidence
of early postoperative complications.21 To date, no comprehensive in-
vestigation reports could be found in this region. Early closure of
the cleft lip and palate can induce many known complications and
life-threatening ones: death, hemorrhage, and upper airway obstruc-
tion.22,23 In past series, these complications were feared and some-
times unexplained. The rule of five-ten (10-g hemoglobin, the
number of blood cell less than 10.0  10^9/L, no problems of the
upper respiratory tract in the past 10 days, 10 weeks of age, and
10 pounds of body weight) was now strictly observed,24 which en-
hanced the surgical safety and reduced the occurrence of com-
plications. Meanwhile, with the improvement of anesthesia and
resuscitation procedures, the age of closure can be safely reduced
even sometimes to the early postnatal period. Overall, the low inci-
dence has been achieved and this can be explained by the collabora-
tion of a highly specialized team.25 However, complications still are
unavoidable clinically and often lead to serious prognosis. In this
study, the whole incidence of complications was relatively higher;
however, the serious cases were on the contrary. To be detailed, there
were 136 cases of the early complications (6.48%, 136/2100) and
pyrexia was the leading complication, followed by incision dehis-
cence and erosion of corner of the mouth, as shown in the Results sec-
tion. As to pyrexia, it may be associated with the following factors:
drug fever, preoperative chronic infection in the respiratory tract,
and wound infection. For the incision dehiscence, the most common
reason found was insufficiently released tension, which accounted
for 6 cases, also including falling down/collision. Drowsiness refers
to feeling sleepy during the day after operation. Generally speaking,
the patients resuscitated within 30 minutes after general anesthesia.
In this group, there were several patients who experienced drowsiness
970
Copyright 2014 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
after the operation. Even 1 kid felt sleepy after 12 hours. This may be
related to the following factors: overdose of anesthetics, slowing drug
metabolism, and poor health status. Respiratory problems are re-
ported to occur in up to 45% and, thus, are not rare after palate sur-
gery.26 Because of the pressure of the tongue retractor, even severe
macroglossia requiring tracheostomy has been reported.27 Because
of agitation of intuition or hidden infection of the respiratory tract,
there were 26 severe respiratory problems that occurred in the study.
It should be kept in mind that one should pay more attention to these
latent factors and possible complications. To be emphasized in this
group, there were 3 patients who died. All the 3 death cases caused
medical lawsuit. An autopsy was conducted and eventually ascribed
2 patients' death to sudden infant death syndrome without obvious
reasons. The third death case was verified to be a variation of congen-
ital heart disease. The 3 major complications were not linked to the
timing of the operation but were directly related to the preoperative
status of the child. Six cases of postoperative hemorrhage were ob-
served when the children were in the recovery period. None needed
a subsequent operation because a local compression on the operated
area sufficed to control the bleeding. However, 2 cases needed a
transfusion (with its related hazards) for low hemoglobin in the post-
operative period. Of the other nonlife-threatening complications,
6 patients were found to have fistula that occurred after the third post-
operative day. The incidence of local infection and dehiscence of lip
closure varies in the literature from 1% to 7.4%,28 most being ob-
served in bilateral clefts. This was the same as that in this study, espe-
cially when large bilateral mobilization and suture of the orbicularis
muscle were performed, even if care is being taken to avoid excessive
tension on skin closure.
As to the long-term complications, it was more clear and ob-
vious. The incidence was much higher than that of the early ones.29
Because it was quite different to define the degree of secondary
FIGURE 5. Types and distribution of late complications after repairing surgery.
A, Number. B, Percentage.
2014 Mutaz B. Habal, MD
The Journal of Craniofacial Surgery Volume 25, Number 3, May 2014
deformity and voice disorders, the percentage of long-term
complications may be markedly variable in different patients. In
this group, 66 of the patients with cleft palate experienced
velopharyngeal incompetence, thus leading to voice disorders in
58 patients. Thirty patients experienced secondary deformity,
mostly in bilateral cleft lip or unilateral complete cleft lip with ex-
traordinary width. The latter palatal fistula occurred after dis-
charge from the hospital after 2 weeks of operation, and it may
be associated with insufficient tension releasing or disobedience
to the physician's orders in eating. That meant a patient tried ordi-
nary food too early, which led to palatal fistula/dehiscence or de-
hiscence of lip. Hearing problem was a long-lasting problem in
patients with cleft palate because of the relationship of inherent
anatomy. Otitis media was easily found in such patients.
Overall, in a series of 2100 consecutive cleft lip and palate
operations, early and long-term complications were demonstrated
in different styles. Death was the most severe complication among
them. To avoid or reduce the occurrence, preoperative checkup
should be emphasized. At the same time, contraindications should
be strictly adhered to for the same reason.
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