|Year : 2016 | Volume
| Issue : 1 | Page : 4-11
The relationship between cleft width and oronasal fistula
Ezekwe Ekwueme Amirize
Department of Surgery, Plastic Surgery Unit, University of Port Harcourt Teaching Hospital, Port Harcourt; Department of Plastic Surgery, National Orthopaedic Hospital, Enugu, Nigeria
|Date of Web Publication||10-Nov-2016|
Ezekwe Ekwueme Amirize
Department of Surgery, Plastic Surgery Unit, University of Port Harcourt Teaching Hospital, Port Harcourt
Source of Support: None, Conflict of Interest: None
Context: Width of cleft palate influences difficulty of surgical repair and indirectly the outcome. Palatoplasty complicated with oronasal fistula causes persistence of speech, feeding, and social problems. Subsequent closure of palatal fistula has high recurrence rate.
Aim: To determine the relationship between palatal cleft width and oronasal fistula.
Setting and Design: One-year prospective nonblinded study.
Materials and Methods: All consecutive patients with cleft palate that presented to the study institutions within the period, and met inclusion criteria were studied. The width of the palatal cleft defect was measured intraoperatively.
Statistical Analysis Used: Chi-square and Mann-Whitney U-tests were used. P < 0.05 were considered statistically significant.
Results: Forty-six patients were studied out of 53 patients seen during the study period. These were 22 males and 24 females giving male to female ratio of 0.92:1. Patients' ages ranged from 10 months to 28 years; 52.17% of the study population were 2 years and below while 47.83% were aged over 2 years. Cleft width ranged from 4 to 25 mm. Nineteen patients developed fistula. Thus, the overall rate is 41.30%. Likelihood of fistula occurring increased as the width of cleft increased. Fistula rate was higher for patients with cleft width above 15 mm. Fistula rate for intravelar veloplasty was 30% and 50% for von Langenbeck repair; this was not statistically significant.
Conclusion: Cleft width is a strong factor in the development of oronasal fistula. The fistula rate suggests a high burden of the problem. Efforts should be made to improve management outcome.
Keywords: Cleft width, intravelar veloplasty, oronasal fistula, von Langenbeck
|How to cite this article:|
Amirize EE. The relationship between cleft width and oronasal fistula. Nigerian J Plast Surg 2016;12:4-11
| Introduction|| |
Orofacial clefts are the most common congenital malformations of the head and neck, , second only to clubfoot as the most common major congenital malformation of the body. ,
The incidence of cleft lip/palate in Caucasians is 1 in 1000 births while cleft palate alone is 1 in 2000 births. , Typical distribution is cleft lip/palate 46%, isolated cleft palate 33%, and cleft lip alone 21%.  The prevalence of orofacial clefts in Nigeria is 0.5 in 1000 births. 
Affected persons experience psychosocial problems, isolation, and teasing by peers. , Postoperative palatal fistula can occur and it has high recurrence rate.  This study aimed to determine the relationship between palatal cleft width and oronasal fistula.
| Materials and methods|| |
This is a 1-year prospective nonblinded study. Ethical approval was obtained from the Research and Ethics Committees of the study institutions. A written informed consent was obtained from each patient's parent/guardian or the adult patient before enrollment into the study.
Inclusion criteria were all patients aged 10 months and above with unilateral cleft lip and palate or isolated cleft palate. Patients with bilateral cleft palate, submucous cleft palate, syndromic cleft palate, those <10 months of age or with broken down primary palatal repair and unilateral cleft lip, and palate patients with incomplete cleft of the alveolus were excluded from the study.
All consecutive patients with cleft palate that presented to both hospitals during the study period, and met the inclusion criteria were included in the study.
Perioperative risks were assessed based on the physical examination, weight (not <10 th percentile of expected weight for age), and a full blood count (minimum hemoglobin of 10 g/dl). Patients were admitted to the hospital at least 1 day before operation.
With each patient under general anesthesia, a Boyle-Davis or Dingman mouth retractor was put in place ensuring not to strangulate the tongue or bruise the lips. The endotracheal tube was secured in the midline of the lower lip and chin. The width of the palatal cleft defect was measured in millimeters using fine pointed calipers at the level of the tuberosities. The mouth and nasal cavities were cleaned with normal saline or povidone iodine soaked gauze and a throat pack put in place. The hard and soft palates and the nasal septum were infiltrated with 1% lidocaine and 1:100,000 epinephrine, avoiding injection directly around the greater palatine vascular pedicle. The added lidocaine enhances the vasoconstriction and hemostasis  and contributes to intraoperative analgesia. 
Intravenous ceftriaxone (30 mg/kg or 1 g for adults) was given at induction of anesthesia. The surgeon performed either a von Langenbeck's repair or an intravelar veloplasty.
With von Langenbeck two-flap technique, the palatal tissues were raised as bipedicled flaps to achieve a side-to-side closure of the cleft margins of both the soft and hard palate.  The operation began by incising the edges of the cleft from anteriorly to the uvula. Next, relaxing incisions were made starting from the upper premolars about 2 mm off the palatal gingival margins of the upper teeth toward the tuberosity. It passed behind the tuberosity and terminated at the anterior pillar of fauces. The palatal incisions were full-thickness incisions (carried down to the bone of the hard palate). Incisions were made using size 15 blades. The mucoperiosteum was elevated widely and carefully avoiding injury to the angles of the mouth. Particular attention was paid to the greater palatine vessels as they tend to tether the mucoperiosteum and impede elevation. At this point, firm but gentle stretching using two elevators on either side of the vessels (one from lateral incision and the other from the cleft margin incision) facilitated further movement of the flap. Alternatively, if necessary to achieve mobilization, a superficial incision was made around the greater palatine neurovascular bundle on the stretched out periosteum. Special care was taken for this maneuver. The hamulus was not fractured. The levator muscle abnormally attached to the posterior aspect of the hard palate was detached.
At this point, further mobilization of the soft palate could be facilitated by inserting a finger into the lateral incision and pressing the soft palate toward the midline. Once the two sides are seen to approximate without tension, the cleft margins were ready for closure. The nasal mucosa was identified and elevated widely.
The soft palate was closed in three layers (nasal mucosa, muscles, and oral mucosa). The nasal mucosa and muscle layers were closed with 4-0 vicryl suture. The hard palate was closed in two layers (nasal mucosa and mucoperiosteal layer). Closure of the oral mucosa was with 4-0 vicryl using alternating horizontal and vertical mattress sutures except the uvula where it is superficially closed with simple interrupted sutures to avoid the uvula being drawn up nasally [Figure 1].
Performing intravelar veloplasty, a longitudinal incision was made with a size 15 blade on the cleft margin from the anterior end to the tip of the uvula. From the junction of nasal and oral mucosa, the incision is made 2 mm on the oral side. With a palatal dissector, the nasal layer was dissected from the palatine bone, insinuating the dissector between the spine and cut nasal layer and finally, laterally, and upward. The dissection continues posteriorly to the skull base so that the nasal flaps can be approximated across the cleft with minimal tension. 
Soft palate muscles were sharply dissected  from the nasal lining and hard palate using scalpel. In dissecting the nasal layer away from the muscles, the muscle was held upward with nontooth dissecting forceps for better delineation and sharp dissection of the nasal layer. The tensor fibers were sharply released from the edge of the hard palate and the tendon divided with scalpel medial to the hamulus.  This medial release of the tensor tendon allows mobilization of the levator muscle so that it can be repositioned across the cleft. The levator was sharply dissected from the oral layer.
The oral layer was mobilized by carefully freeing soft tissue surrounding the pedicle and tissue tethering it to the palatine bone at the alveolar margin. Freeing was done until approximation at midline was possible without tension.
This procedure was repeated on the other side using a new size 15 blade.
The oral layer was detached from the anterior margin for wide clefts (clefts wider than 15 mm) using the curved palatal elevator. Furthermore, for some wide clefts, a vomerine flap was designed for closure of the nasal layer. Vomerine flap was elevated with a midline incision, flap elevated with palatal dissector. Extended vomerine flap was developed with a U-shaped curvature at the skull base to augment tissue at the junction of the soft and hard palate.
For very wide clefts, a Bardach 2-flap was developed maintaining the pedicle which was freed.
Nasal layer closure began at the junction of soft and hard palate with interrupted 4-0 vicryl. This continued with direct approximation of the nasal lining of the soft palate across the cleft posteriorly to the uvula. The nasal layer closure was then continued anteriorly.
The mobilized velar muscles were reoriented, transposed across the cleft, and repaired end to end at the midline with two horizontal mattress 4-0 vicryl sutures [Figure 2]. This method conforms to Cutting's technique of intravelar veloplasty.  Musculus uvula was repaired with vicryl 4-0.
Oral layer was closed similarly from posterior to anterior. 
At the end of each procedure, throat pack and mouth gag were removed, anesthesia discontinued and patient extubated.
Postoperatively, patients were monitored using pulse oximetry in the recovery room, nasopharyngeal airway was inserted on some patients, oxygen given via nasal prongs and patients' mouths suctioned regularly in the immediate postoperative period. Pulse oximetry was discontinued, once patient maintained adequate saturation at room air. Intravenous fluid was continued for 24-48 h. Using a cup and a spoon, oral fluid was commenced later on the day of surgery when the patient was fully conscious. The children did not suck for 3 weeks postoperative. Antibiotic therapy was continued for at least 5 days. Using cup and spoon, soft foods (pap, custard) were commenced by the 1 st -2 nd day postoperative. Liberal clear fluids were given after each meal. The patient was discharged after 5 days on soft diet to be continued for about 3 weeks.
Postoperative reviews were done. After the 3 rd postoperative week, sucking and blowing (e.g., whistles) were employed as a form of physiotherapy to encourage velopharyngeal closure. Patients were followed up weekly for 4 weeks, and then monthly for up to 9 months after the surgery. Mean follow-up period was 5 months. At these outpatient visits, parents/patients were interviewed on compliance with soft diet and about whether there had been nasal leaks of fluid or soft diet. Intraoral examination was performed during which palatal suture lines were inspected closely for fistulous opening.
Fistula locations were noted when they occurred.
The patients that developed fistulas were evaluated with respect to the site, time of occurrence, and cleft width. All data regarding each patient were recorded in a study proforma for analysis. Statistical analysis of the data was performed using SPSS Statistics for Windows, Version 17.0. Chicago: SPSS Inc. Results were presented in tables (frequencies and percentages), bar charts, histogram, and pie charts. Fistula rates in the surgical procedures were calculated and findings subjected to Chi-square tests. The cleft width and incidence of oronasal fistulae were subjected to the Mann-Whitney U-test. P < 0.05 were considered statistically significant.
| Results|| |
A total of 46 patients were studied, 22 males and 24 females. Mean age was 5.87 ± 7.49 years with age range of 0.83 years (10 months) to 28 years and a mode of 1 year. Twenty-four (52.17%) patients were aged 2 years and below while 22 (47.83%) were aged over 2 years [Table 1].
According to the Veau classification, there were one Veau I cleft (cleft of the soft palate), 22 Veau II clefts (clefts of the hard and soft palate up to incisive foramen), and 23 Veau III clefts (complete unilateral clefts).
The minimum width of cleft was 4 mm and maximum 25 mm, with a mean value of 13.89 standard deviation ± 5.36 mm [Figure 3]. The average preoperative cleft widths in patients who had fistulae ranged from 9 mm to a widest of 24 mm.
|Figure 3: Histogram of the distribution of cleft width at palatoplasty indicating a bivariate distribution with two peaks at 15 and 20 mm|
Click here to view
Cleft width was <15 mm in 25 (54.35%) patients as shown in [Table 2]. These were equally distributed between Veau II and Veau III clefts (12; 48.00%). One (4.00%) patient in this group had Veau I cleft.
Five (10.87%) patients had cleft width of 15 mm and 16 (34.78%) patients had cleft width exceeding 15 mm. This sums up to 21 (45.65%) patients with cleft width of 15 mm and above. These patients were almost equally distributed between Veau II (10) and Veau III (11) clefts. Most (14; 66.67%) were children under 5 years of age.
Fistula rates were higher for patients with wide clefts (>15 mm). Nineteen (41.30%) patients developed fistulae postpalatoplasty [Figure 4].
Eleven (57.89%) of these patients had cleft width exceeding 15 mm [Table 2].
Fifteen (71.43%) patients with cleft width of 15 mm and above developed fistulae following palatoplasty. Oronasal fistulae were seen in 4 (16.00%) patients with cleft width <15 mm.
The correlation between cleft width and oronasal fistula was statistically significant (u = 100.500, P = 0.000).
All fistulae occurred in Veau II and Veau III clefts with a slight preponderance in Veau III clefts (11 Veau III, 8 Veau II).
The earliest and latest fistulae were seen on day 2 and day 18 postoperative, respectively.
All palatal fistulae occurred within 3 weeks of surgery. Most were observed during the second (11; 57.89%) postoperative week. Highest frequencies were day 10, 13, and day 14 postoperative.
Five (26.31%) fistulas occurred within 7 days of palatoplasty. Two of these resulted from wound dehiscence in patients with 20 mm cleft width measured at palatoplasty. Meantime was 10.37 ± 5.01 days.
All fistulae seen were clinically significant as complaints of hypernasal speech or nasal regurgitation, or both were received [Figure 5].
Fistula location varied. Thirteen of 19 fistulae (68.42%) were at the hard/soft palate junction. Other locations include 3 (15.79%) at the secondary hard palate, 2 (10.53%) at the soft palate, and 1 (5.26%) at the junction of primary and secondary palate [Figure 6].
Intravelar veloplasty was performed in 20 (43.48%) patients, 6 of whom developed fistula. This gives a fistula rate of 30.00% with intravelar veloplasty.
There were 26 (56.52%) von Langenbeck repairs with 13 fistulae seen. This brings the fistula rate to 50.00% with this procedure. The mean width of cleft in patients who had von Langenbeck repair was 15.23 mm and 12.15 mm for those who had intravelar veloplasty. However, these surgical procedures were found not to significantly influence the fistula rate statistically (P = 0.172).
| Discussion|| |
Almost half of the patients studied were aged over 2 years. The commonly accepted protocol for primary palatoplasty is repair at 9-12 months of age. ,,,, This protocol is adopted because it is associated with better speech outcome.  Similarly, Aziz et al.,  in Bangladesh, performed palatoplasty for patients above 1 year of age.
Some patients with cleft lip and palate are lost to follow-up after cleft lip repair due to the satisfaction they get from cleft lip repair before palatoplasty. This has led some workers to perform combined cleft lip and palate repairs in some cases.  Palatoplasty before lip repair has been advocated for all cleft lip and palate patients presenting late in developing countries. This is to avoid the dropout and delay in repair of the functionally important palate in these patients.  External influence in decision-making may be another factor responsible for late presentation. This may be blamed on the strong communal lifestyle in the subregion.
The cleft width showed a direct correlation with the risk of oronasal fistula formation. Some studies which demonstrated that the width of cleft at the time of palatoplasty play a crucial role in postoperative fistula development also noted that palatal fistula rate increased as cleft width increases. ,,, Landheer et al.  in the Netherlands found cleft width of 13 mm and above to be a predictor of fistula.
Fistula rate was high among patients with wide clefts (≥15 mm), and most fistulae were seen in this group of patients. This corroborates the finding of Parwaz et al.  in India that cleft width of 15 mm or more has a statistically significant risk of fistula formation.
The relatively high fistula rate found in this study is within some ranges reported in the literature: 0-45%,  10-50%,  0-63%,  and 0-76%.  These fistula rates highlight the problem of the secondary fistula with which cleft width has a strong association.
However, lower fistula rates have also been reported. With a protocol modification, Losken et al.  had a fistula rate of 1.6% while Wilhelmi et al.  using the Bardach 2-flap palatoplasty had a 3.4% fistula rate. Cohen et al.  observed a 0% fistula rate with the Dorrance style closure.
Fistula rates in the literature are results of different surgical techniques performed on patients with different cleft characteristics.
The surgical technique alone does not guarantee avoidance of fistula, but to avoid fistula surgeons should adhere to particular principles of repair such as the tension-free closure of the nasal and oral layers, especially at the hard/soft palate junction and minimal trauma to palatal flap margins by instruments. , Cohen et al.  similarly had a fistula rate of 30.00% with intravelar veloplasty and a contrasting 22.00% with von Langenbeck repair.
The surgical maneuvers of intravelar veloplasty may have made the difference. These include a complete levator sling reconstruction, total release of tensor tendon, use of relaxing incisions, neurovascular bundle dissection, and inclusion of Bardach flap in some cases.
These approaches have been proposed by the Pittsburgh University algorithm for limiting fistula during palatal surgery.  As recommended by this algorithm, use of acellular dermal matrix would have reduced fistula rate in this study.
However, Losken et al.  when limiting von Langenbeck palatoplasty to clefts <8 mm in width had a significant reduction in fistula rate in America (1.6% vs. 35.8%).
Symptoms of palatal fistula complained about include nasal regurgitation of liquids and occasionally solid food, lodging of solid food particles in fistulae, and halitosis from impacted food particles. Nasal secretions also seeped into the mouth with attendant poor oral hygiene. This probably contributed to the fetor oris. Hypernasal speech was observed in some patients.
These fistulae should be closed at some point to improve velopharyngeal function and provide a healthy oral and nasal environment.
In principle, the patient has to persevere for some additional time, obviously without the succor initially sought. This is because oronasal fistula closure is not attempted too early. The surgeon waits until the area is fully healed and inflammation subsided completely. Six to 12 months is, however, the average time for the blood supply to re-establish itself satisfactorily after primary palatoplasty.  The difficulty in treating this problem may be reflected by the many surgical techniques applied for its repair, ranging from local flap to free tissue transfer. ,, While Landheer et al.  and Diah et al.  report a recurrence rate of 9% and 25%, respectively, the recurrence rate of palatal fistulae reportedly approaches 100%. 
Evidenced by its propensity toward recurrence, the problem of oronasal fistula is therefore best treated by preventing it.
Most fistulae were at the hard/soft palate junction. The hard/soft palate junction which is generally the widest portion of a cleft , has an atrophic mucosa. This factor with the constant motion of the soft palate against the hard palate all challenge successful closure at this site.  Furthermore, other than having inadequate muscle centrally, the site was noted to have the greatest tension at closure. This is especially so in the wide palatal clefts. This warranted the use of certain maneuvers such as lateral relaxing incisions and medial release of tensor tendon to achieve more medial advancements during palatoplasty. For some very wide clefts, vomerine flap and Bardach 2-flap were used with intravelar veloplasty to achieve successful closure.
Shah et al.  in Pakistan and Ogle  in America also observed that palatal fistula typically occurs at the junction of hard/soft palate.
However, de Agostino Biella Passos et al.  in a recent retrospective review in Brazil found that most fistulae were located in the anterior palate. Palatal fistulas in the anterior palate are best avoided by careful suturing technique.  During the various repairs, surgeons endeavored to incorporate the oral and nasal mucosae together with the anterior-most suture on the hard palate. This helped to obliterate dead space and prevent hematoma formation.
Avoidance of oronasal fistula is a short-term goal of palatoplasty.  The first 4 weeks of repair is critical for the development of secondary palatal fistula. , Berkman  found all 11 fistulae within 10-14 days postpalatoplasty and Shah et al.  diagnosed all fistulae within 3 weeks of surgery.
Similarly, a significant number of fistulae were diagnosed in the 2 nd week postrepair.
By the 3 rd week, all fistulae were already seen. Nevertheless, even though fistula may become evident within a few weeks of cleft repair, its development may be noted in the immediate postoperative period.  Large cleft width alongside other factors may have occasioned the wound dehiscence that resulted in a few of the early fistulas in this study. According to Lu et al.  wound dehiscence of the oral mucosal layer healed spontaneously. They attributed the absence of oronasal fistula and support for spontaneous healing to an intact layer of nasal mucosa. This gives an insight into the importance of good nasal layer closure. Other workers also report spontaneous fistula closure. ,
In this prospective study, all fistulae developed within the first 3 weeks of repair as observed by the other investigators. This underscores the need for adequate follow-up in the first 4 weeks postrepair.
A fistula rate of 41.30% urges us to critically evaluate our current treatment approach and propose a surgical management protocol. The data encourages the use of intravelar veloplasty generally. The 15 mm width should be the basis for parental counseling for possibility of secondary fistula. Careful development of the nasal layer and tension-free closure, especially at the hard/soft palate junction, and use of vomerine flaps are important. Careful suturing techniques are invaluable. Adequate follow-up, especially in the first 4 postoperative weeks with emphasis on fluid diet, is imperative.
All these measures are aimed at achieving the best outcome with the initial cleft repair, eliminating oronasal fistula, and its attendant problems.
Continued open discussion of results of cleft palate repairs from various centers is also necessary. This could be in the form of regular cleft workshops with a strong interest in training and re-training cleft surgeons. Effective referral system is important.
Finally, there should be more efforts at enlightenment campaigns to encourage early presentation to hospitals for cleft repair. This could be done as outreaches for cleft lip repair in the hinterlands where encouragement will be given for cleft palate management in the hospital. Furthermore, the formation of clubs for cleft patients with open membership may greatly influence campaign. Support from such clubs may take campaign closer to the community and change negative public perception.
| Conclusion|| |
The results suggest that cleft width is a strong factor in the development of oronasal fistula.
The fistula rate increased as the cleft width increased and the incidence of oronasal fistula was 41.30%. Fistula rate was higher in von Langenbeck repair than intravelar veloplasty, 50.00%, and 30.00%, respectively. Most fistulae were located at the hard/soft palate junction and all fistulae developed within 3 weeks of palatoplasty.
Urgent steps are therefore needed to reduce this problem especially in our subregion.
The author would like to thank Dr. I. I. Onah and Dr. J. T. Gbeneol for their supervisory role during this work. The author also expresses sincere gratitude to Dr. I. S. Ogbonnaya, Dr. R. E. E. Nnabuko, Dr. J. U. Achebe, and Prof. F. C. Akpuaka for reviewing the manuscript at various phases of this project.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2]