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 appropriate angle between the Z-flap incision and the central axis, use of a bilateral relaxation incision, and postoperative nursing care can help reduce the incidence of postoperative cleft relapse.
Cleft palate is the second most common human birth defect, and it poses a great physiological and social challenge to affected patients. A wide range of surgical procedures have been described for the repair of cleft palate. However, none has proved to be superior to the others or is suitable for all patients, and a standard protocol is still lacking. Among the many palatoplasties, the Furlow double opposing Z-plasty (also known as the Furlow palatoplasty), 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 closure function. It has been reported that patients treated with the Furlow palatoplasty can achieve 90% of palatopharyngeal closure function, which is higher than that achieved with other procedures, like the von Langenbeck procedure, one-flap push-back palatoplasty, and the Sommerlad procedure. Since 2002, the Furlow palatoplasty has become one of the most commonly used procedures for palate repair.
Oronasal fistula is the most common complication after palatoplasty. Most commonly, sutures within the oral mucosa 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 fistula. An oronasal fistula can result in nasal leak, dysarthria, hearing impairment, food reflux, and maxillary hypoplasia, greatly harming and inconveniencing the patient. Oronasal fistula continues to be a challenge for cleft surgeons, and thus research-based guidelines for selecting the optimal techniques or procedures to decrease the rate of fistula are important.
The Furlow palatoplasty is associated with a lower incidence of oronasal fistula (5.6–10%) compared with other palatoplasty procedures such as the von Langenbeck procedure (22%) and one-flap push-back palatoplasty (43%); however, the incidence is still high in cases of wide clefts. Given that the occurrence of palatal fistula might be related to multiple factors, such as high tension in the local sutures, infection, injury, haematoma, and tissue necrosis, identifying the risk factors for the development of an oronasal fistula after Furlow palatoplasty is of great significance in terms of optimizing the indications for this widely accepted procedure.
Several studies have reported the incidence rates of cleft relapse and oronasal fistula after other palatoplasty procedures, but there are relatively few reports on the incidence of postoperative cleft relapse and oronasal fistula after Furlow palatoplasty in infants.
Considering that palatoplasties performed at the infant stage are conducive to the normal development of phonetic function, 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.
Materials and methods
This study consisted of an evaluation of all cleft palate patients treated at the authors’ centre from March 2012 to August 2014. The inclusion criteria were (1) age between 6 and 12 months; (2) complete or incomplete cleft palate, including 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 follow-up. Exclusion criteria were patients with syndromic cleft palate, such as those with Pierre Robin syndrome, congenital velopharyngeal insufficiency, and submucous cleft palate. Informed consent was obtained from the guardian of each infant, and the study protocol was approved by the ethics committee of the study centre.
The Furlow double opposing Z-plasty was performed as described previously. The key point of the Furlow palatoplasty is to design two opposing Z flaps beside the cleft, forming a musculomucosal flap 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 dissected within the mucosa. Then the edges of the cleft are cut open and the palatine muscle is cut off at the location of its attachment, forming a triangular flap with the posterior pedicle. Next, on the other side of the cleft, the mucosa is stripped at the superficial layer of the palatine muscle, forming a mucosal flap with an anterior pedicle. Thus, the Z-flap in the oral cavity is created. The Z-flap in the nasal cavity is created following the same steps. In the suture step, the flaps in the nasal cavity are mutually diverted and sutured first, followed by the flaps in the oral cavity.
For the patients in this study, the nasal mucosa was sutured with non-absorbable 5–0 Vicryl sutures; interrupted suturing with absorbable 5–0 sutures was applied to the oral mucosa. For the hard palate portion, where a fistula can easily develop, mattress sutures were adopted to avoid excessive involution of the front part of the mucosa . All of the procedures were performed by one surgeon (FL), who was skilled in this technique before the study was performed.
After surgery, treatments including local debridement, regular flushing, and wet dressing were given, as well as a prescription for mouthwash. All of the children were observed until day 3 after surgery. The children were discharged once it was confirmed that they had no abnormal routine blood test results and no signs of surgical wound infection. Epidermal growth factor for local application was administered to promote wound healing.
All patients underwent physical examinations at 1 week and 3 months after surgery, in which the healing status of the incision and the presence and location of cleft relapse or fistula were recorded. On the basis of the Pittsburgh Fistula Classification System, palatal fistulae can be classified into seven types: I, bifid uvula; II, soft palate; III, junction of the soft and hard palate; IV, hard palate; V, junction of the primary and secondary palates (for Veau IV clefts); VI, lingual alveolar; and VII, labial alveolar. The fistulae seen in the present study were of types I–V ( Fig. 1 ).
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 midpoint 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 pterygomandibular 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 postoperative cleft relapse and fistula.
All statistical analyses were performed using SPSS version 17.0 software (SPSS Inc., Chicago, IL, USA). Univariate analysis was initially used to select possible variables, and multiple logistic regression analysis was then used to identify the independent factors. The receiver operating characteristic (ROC) curves of the identified risk factor(s) were plotted to calculate the area under the curve (AUC). P < 0.05 was considered statistically significant.
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.
|Location||Number of patients with fistula ( n )||Rate ( n / N ) a||Recovery rate (100.0%– n 2/ n 1) b|
|1 week PO ( n 1)||3 months PO ( n 2)||1 week PO||3 months PO|
|Junction of soft and hard palates||9||2||60.0%||33.3%||77.8%|
|Junction of primary and secondary palates||2||2||13.3%||33.3%||0.0%|
At 3 months after surgery, only two relapses occurring at the junction of the soft and hard palates developed into oronasal 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 multivariate 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 factor for oronasal fistula on multivariate analysis ( P = 0.011; Table 3 ).
|Variable||Healing condition at 1 week after procedure||Univariate analysis||Multivariate analysis||AUC analysis|
|Normal||Relapse||P -value||β||SE||Wald χ 2||P -value||OR||95% CI||AUC||SE||P -value||95% CI|
|Age (months)||8.1 ± 2.2||8.9 ± 1.8||0.209|
|Type of cleft||0.031 *|
|Length of soft palate||15.7 ± 2.3||17.5 ± 3.1||0.017 *||0.615|
|Width of soft palate||29.0 ± 4.3||29.7 ± 4.4||0.580|
|Width of hard palate||35.4 ± 2.55||36.0 ± 2.54||0.462|
|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||1.359–3.354||0.843||0.052||0.000 *||0.741–0.944|
|Variable||Healing condition at 3 months after procedure||Univariate analysis||Multivariate analysis||AUC analysis|
|Normal||Fistula||P -value||β||SE||Wald χ 2||P -value||OR||95% CI||AUC||SE||P -value||95% CI|
|Age (months)||8.2 ± 2.2||8.8 ± 1.8||0.493|
|Type of cleft||0.038 *|
|Length of soft palate||16.0 ± 2.5||17.5 ± 3.4||0.174|
|Width of soft palate||29.0 ± 4.5||30.2 ± 2.6||0.520|
|Width of hard palate||35.7 ± 2.6||34.5 ± 1.9||0.277|
|Length of cleft||19.2 ± 4.6||21.3 ± 2.8||0.297|
|Width of cleft||7.3 ± 2.7||10.5 ± 1.3||0.006 *||0.675||0.265||6.481||0.011 *||1.963||1.168–3.300||0.869||0.056||0.003 *||0.759–0.979|