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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 4  |  Issue : 3  |  Page : 160-166

The relationship between cleft palate index and oronasal fistula


1 Department of Surgery, Plastic Surgery Unit, University of Port Harcourt Teaching Hospital, Port Harcourt; Department of Plastic Surgery, National Orthopaedic Hospital, Enugu, Nigeria
2 Department of Plastic Surgery, National Orthopaedic Hospital, Enugu, Nigeria
3 Department of Surgery, Plastic Surgery Unit, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria
4 Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, College of Health Sciences, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria

Date of Web Publication21-Nov-2017

Correspondence Address:
Ezekwe Ekwueme Amirize
Department of Surgery, Plastic Surgery Unit, University of Port Harcourt Teaching Hospital, Port Harcourt
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jclpca.jclpca_30_17

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  Abstract 

Aims and Objectives: To identify fistula rates and determine the relationship between cleft palate index (CPI) and oronasal fistula. To delineate palatal index with high risk of fistulation in our study population. Materials and Methods: A 1-year prospective study. All consecutive patients with cleft palate that presented to the study institutions within the period and met inclusion criteria were studied. Palatal cleft width was measured in millimeters using fine pointed calipers at the level of the tuberosities intra-operatively. Maxillary intertuberosity width was measured. CPI was calculated as a ratio of cleft width to maxillary width. Palatoplasty was by von Langenbeck repair or intravelar veloplasty. Data were documented and analyzed. P < 0.05 were considered statistically significant. Results: Forty-six patients were studied. Ages ranged from 10 months to 28 years. Ranges of measured parameters were cleft width 4–25 mm, maxillary width 35–82 mm and CPI 0.07–0.49. Nineteen patients developed oronasal fistula; 41.30% overall fistula rate. Likelihood of fistula occurring increased as palatal index increased. Fistula was common in patients with CPI in excess of 0.22. Risk of fistula formation was statistically significant, becoming higher with palatal index of 0.26 and above. Discussion and Conclusion: Cleft palate exhibits great variability in tissue deficiency and segments separation. This may influence cleft severity. Palatal index estimates cleft severity and allows identification of patients at risk of fistula formation thereby necessitating individualized surgical attention for a better outcome.

Keywords: Cleft palate index, intravelar veloplasty, oronasal fistula, von Langenbeck


How to cite this article:
Amirize EE, Onah II, Gbeneol TJ, Adeniyi OA. The relationship between cleft palate index and oronasal fistula. J Cleft Lip Palate Craniofac Anomal 2017;4, Suppl S1:160-6

How to cite this URL:
Amirize EE, Onah II, Gbeneol TJ, Adeniyi OA. The relationship between cleft palate index and oronasal fistula. J Cleft Lip Palate Craniofac Anomal [serial online] 2017 [cited 2022 Jan 27];4, Suppl S1:160-6. Available from: https://www.jclpca.org/text.asp?2017/4/3/160/218870


  Introduction Top


The successful treatment of cleft palate requires technical skill and in-depth knowledge of the abnormal anatomy.[1]

Primary goals of palatoplasty are single operation and primary healing, ultimately to provide a more competent mechanism for speech.[2] However, fistula occurs in some cases[3] and it remains a challenge.

It represents technical failure resulting from poor wound healing, tension or absence of multilayer repair.[2],[4],[5] The recurrence rate is high.[6]

Reported fistulae rate range from 10% to 15%,[1] 11%–23%,[3] 10%–50%,[7] 0–63%,[6] and 0%–76%.[8] Surgeon's experience, initial cleft severity and repair procedure used influence incidence.[9]

Studies show a correlation between cleft width and fistula.[10],[11] Cleft palate exhibits great variability in tissue deficiency; this may influence cleft severity.[12]


  Materials and Methods Top


This is a 1 year prospective non-blinded study. Ethical approval was obtained from Research and Ethics Committees of the study institutions. A written informed consent was obtained before enrollment into the study.

The inclusion criteria were all nonsyndromic patients aged 10 months and above with unilateral cleft lip and palate or isolated cleft palate. Perioperative risks were assessed based on physical examination, weight (not <10th percentile of expected weight for age) and a full blood count (minimum hemoglobin of 10 g/dl).

For the purpose of this study, surgeons who performed the procedures were grouped into two; those who repair 5 palatal clefts and above per year were regarded as the experienced palate surgeons while those who perform less were regarded as less experienced palate surgeons.[13],[14]

With each patient under general anaesthesia, a Boyle-Davis or Dingman mouth retractor in place, the width of palatal cleft defect was measured in millimeters using fine pointed calipers at the level of the tuberosities. The maxillary inter-tuberosity width was measured, and cleft palate index (CPI) obtained as a ratio of cleft width to maxillary intertuberosity width [Figure 1]. The hard and soft palates and the nasal septum were infiltrated with 1% lidocaine and 1:100,000 epinephrine,[15] avoiding injection directly around the greater palatine vascular pedicle. The added lidocaine contributes to intraoperative analgesia.[16] Intravenous ceftriaxone was given at induction of anaesthesia.
Figure 1: Measurements for cleft palate index. Index = b ÷ (a+b+c)

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The surgeon performed either a von Langenbeck's repair or an intravelar veloplasty.

With von Langenbeck two-flap technique, palatal tissues were raised as bipedicled flaps to achieve a side-to-side closure of the cleft margins of both soft and hard palate.[1] Particular attention was paid to the greater palatine vessels as they tend to tether the mucoperiosteum and impede elevation. The hamulus was not fractured. The levator muscle abnormally attached to the posterior aspect of the hard palate was detached. The nasal mucosa was identified and elevated widely. The soft palate was closed in three layers (nasal mucosa, muscles, and oral mucosa). The hard palate was closed in two layers (nasal mucosa and mucoperiosteal layer).

Cutting's technique of intravelar veloplasty was used.[1] Also, for some wide clefts, a vomerine flap was designed for closure of the nasal layer. The extended vomerine flap was developed with a U-shaped curvature at the skull base to augment tissue at the junction of soft and hard palate.

For very wide clefts, a Bardach 2-flap was developed maintaining the pedicle which was freed.

Postoperative management was done and included antibiotic therapy for at least 5 days. Using a cup and a spoon oral fluid was commenced later on the day of surgery when the patient was fully conscious, soft foods (pap, custard) were commenced by the 1st to 2nd day postoperative. Liberal clear fluids were given after each meal. The patient was discharged after 5 days on soft diet to be continued for 3 weeks. The children did not suck for 3 weeks postoperative.

Postoperative reviews were done. After the 3rd 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, then monthly for up to 9 months. 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 diet. Intraoral examination was performed during which palatal suture lines were inspected closely for fistulous opening.

Fistula locations were noted when they occurred. Patients that developed fistulas were evaluated with respect to site, time of occurrence and CPI. The statistical analysis of data was performed using the Statistical Package for Social Sciences (SPSS 17.0) Chicago, IL.

Fistula rates in the surgical procedures were calculated and findings subjected to Chi-square tests. The CPI and incidence of oronasal fistulae were subjected to the Mann–Whitney U-test. P < 0.05 was considered statistically significant.


  Results Top


Forty-six 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.

The minimum width of cleft was 4 mm, maximum 25 mm, with a mean of 13.89 standard deviation (SD) ± 5.36 mm. Maxillary widths ranged from 35 mm to 82 mm, mean was 56.63 SD ± 11.97 mm. CPI ranged from 0.07 to 0.49, with a mean of 0.25 SD ± 0.10 and mode 0.27.

Nineteen (41.30%) patients developed fistulae post palatoplasty. The likelihood of fistula occurring increased as CPI increased. Fistula was common in patients with CPI in excess of 0.22. Eighteen (39.13%) patients had cleft palate indices <0.22, with only one fistula in that group. All other fistulae were seen among 28 (60.87%) patients with CPI of 0.22 and above [Figure 2]. The risk of fistula formation became higher with palatal index of 0.26 and above. The CPIs in patients who had fistula ranged from 0.14 to 0.49, with a mean of 0.31. The correlation between CPI and oronasal fistula was statistically significant (U = 96.000, P = 0.000).
Figure 2: Cleft palate indexes and oronasal fistulae

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The earliest and latest fistulae were seen on day 2 and day 18 postoperative respectively.

All fistulae occurred within 3 weeks of surgery. Most were observed during the 2nd (11; 57.89%) postoperative week. Highest frequencies were tenth, 13th and 14th postoperative days. Five (26.31%) fistulas occurred within 7 days of palatoplasty. Two of these resulted from wound dehiscence in patients with 0.27 and 0.36 indices, respectively. Mean time was 10.37 ± 5.01 days. All fistulae seen were clinically significant as complaints of fetor oris, nasal regurgitation or both were received.

Fistula location varied. Thirteen 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 the primary and secondary palate.

Intravelar veloplasty was performed on 20 (43.48%) patients, six of whom developed fistula giving a fistula rate of 30.00%.

There were 26 (56.52%) von Langenbeck repairs with 13 fistulae seen. This brings the fistula rate to 50.00%. The mean CPIs in patients who had von Langenbeck repair was 0.27, and 0.24 for intravelar veloplasty. Among those who developed fistula, mean indexes were 0.32 and 0.31, respectively, for von Langenbeck and intravelar veloplasty [Table 1]. However, these surgical procedures did not significantly influence the fistula rate statistically (P = 0.172).
Table 1: Relationship between cleft palate index, oronasal fistula, and surgical procedure

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Surgical procedures were performed by eight surgeons, 3 (37.50%) of whom were experienced palate surgeons while 5 (62.50%) were less experienced palate surgeons.

Experienced surgeons performed 29 (63.04%) procedures while the less experienced surgeons performed 17 (36.96%).

Experienced surgeons used intravelar veloplasty for 13 patients, 3 (23.08%) of whom developed fistula. Less experienced surgeons performed 7 intravelar veloplasty and had fistula in 3 (42.85%) patients [Figure 3]. P value for intravelar veloplasty was 0.336.
Figure 3: Intravelar veloplasty, Surgeons' experience and Fistula rate

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Six out of 16 (6; 37.50%) von Langenbeck repairs by experienced palate surgeons had fistula. The less experienced palate surgeons performing von Langenbeck repair had higher fistula rate; 7 (70.00%) in 10 procedures [Figure 4]. However, P = 0.107.
Figure 4: von Langenbeck repair, Surgeons' experience and Fistula rate

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  Discussion Top


The relationship between CPI and oronasal fistula was studied. The surgical technique and surgeon's experience were other variables investigated to identify their influence in secondary unintentional fistula.

The CPI showed a direct correlation with the risk of oronasal fistula formation. Some studies have demonstrated that the width of cleft palate at the time of palatoplasty plays a crucial role in postoperative fistula development and noted that palatal fistula rate increased as cleft width increases.[9],[10],[11],[17] However, these studies considered only the width of the cleft defect. As in our study, the palatal index, in addition, considers the associated tissue deficiency, unlike the cleft width alone. The relation of the cleft width to the available soft tissue for palatal flap is indicated by the CPI. This would provide better insight into the pathology and encourage better surgical planning for good outcome.

Parwaz et al.[11] evaluated fistula formation after a follow-up period of at least 4 weeks postoperative. They concluded that the cleft width affected the occurrence of postoperative palatal fistula and that the strongest association was found for the ratio of the cleft width to the sum of the palatal shelf width. If this ratio was 0.48 or more, the risk of fistula formation was statistically significant. Like our study, they tried to evaluate the effect of associated tissue deficiency.

Rossell-Perry et al.[18] also found a statistically significant association between palatal index and oronasal fistula. The 0.26 palatal index with a higher risk of fistula formation observed in this study corresponds to moderate degree of palatal index according to the classification proposed by Rossell-Perry et al.[18] The difference between the indexes with a significant risk between the studies could arise from the method of calculation, patient's age, surgical procedure used and surgeon's experience.

The main difference between ours and these two studies is the method of palatal index calculation. Instead of the sum of palatal shelves as denominator, we considered the maxillary intertuberosity width. This width is pertinent to possible tension at tissue transposition, especially during intravelar veloplasty. Therefore, relative to the sum of palatal shelf widths lesser index values were obtained using our method. This is responsible for the relatively lower index with a significant risk of fistula in our study. However, unlike Rossell-Perry et al.[18] different Plastic Surgeons involved in our study is a cause of lack of uniformity in the study and thus is one of our drawbacks.

Cleft severity varies at birth and during infancy. Furthermore, the cleft size increases significantly secondary to patient growth as well as maxillary expansion transversely and anteriorly as reported by Aziz et al.[19] in their experience on adult cleft palate. They found that the primary problems with palatoplasty in adult cleft results from increased width with vertically displaced palatal segments. This is attributed to prolonged tongue interposition.[19] Similarly, 23.91% of our study population were adult clefts. However, their study did not state cleft width dimensions or palatal indexes in the subjects.

Suzuki et al.[20] reported the use of fine-pointed calipers intraoperatively to measure three widths of the palatal cleft intraorally to the nearest 0.5 mm by the surgeon. The cleft width at the level of the hamulus pterygoides they called cleft palate width (CPW), the width between the right and left hamulus was called the interhamular width (IHW), and the ratio of CPW/IHW defined as CPI. They concluded that the width of cleft palate was significantly correlated with wider maxillary facial width and wider posterior dental arch width in unilateral cleft lip and palate. Therefore, the CPIs and hence fistula rate in our study may have been influenced by the patients' age since most repairs were on grown children, adolescents and adults. Like the maxillary inter-tuberosity width, the IHW incorporates cleft width and the palatal shelf widths, and both are taken in close proximity to the tensor veli palatini tendon. This method of measurement thus considers ease or difficulty of closure, especially at the hard/soft palate junction.

The relatively high fistula rate in this study is within some ranges reported in the literature; 0%–45%,[21] 10%–50%,[7] 0%–63%,[6] and 0%–76%.[8] These fistula rates highlight the problem of the secondary fistula with which CPI has a strong association. However, lower fistula rates have also been reported.[18],[21],[22],[23] Fistula rates in the literature are results of different surgical techniques performed by surgeons of various experience on patients with different cleft characteristics as in our study.

The relative contribution to fistula formation by surgeon's level of expertise and repair technique is a closely and intricately linked argument. Both inexperienced and choice of inappropriate technique clearly contribute to fistula formation.[21] These as drawbacks would have contributed to fistula rate in this study. 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 nasal and oral layers especially at the hard/soft palate junction and minimal trauma to palatal flap margins by instruments.[4],[21] Cohen et al.[23] similarly had a fistula rate of 30.00% with intravelar veloplasty and a contrasting 22.00% with von Langenbeck repair.

Some studies found the surgeon's experience to influence fistula rate.[2],[8],[9],[21] However, Al-Nawas et al.[24] and Cohen et al.[23] found no significant effect on fistula occurrence by the surgeon's experience. Surgeons with extensive cleft experience may be able to use any of the several surgical techniques with good outcomes.[21] In our study, while performing the intravelar veloplasty, the experienced surgeons recorded a lower fistula rate likewise with von Langenbeck repair. Several factors other than the CPI could contribute to these results especially in the event of lower fistula rates among both groups of surgeons with the intravelar veloplasty. The surgical maneuvers of the technique may have made the difference.

According to Losee et al.,[8] the surgeon experience is the strongest predictor of fistula formation. Some experienced surgeons using a single technique report low fistula rates while less experienced surgeons use the same technique and note excessive fistula formation.[21] This is probably the case with fistula rates obtained with von Langenbeck palatoplasty in this study; fistula rate of the less experienced surgeons was close to double that of experienced surgeons. Although not statistically significant, von Langenbeck repair had a higher tendency toward oronasal fistula formation with less experienced surgeons. This is despite the regular use of von Langenbeck technique by both groups of surgeons before the commencement of this study. The surgeon's experience as a strong predictive factor is thus evident.

In addition, some studies that found lower fistula rates with less experienced surgeons[21] or no influence by the surgical experience of the operating surgeon on fistula outcome,[8],[24] had an experienced surgeon “hands-on” all the time during the surgery, controlling each step. However, this was not the case in our study. To further buttress the importance of surgeons experience and repair technique, it was our observation that lower fistula rate occurred in index range 0.401–0.500 than the 0.301–0.400 group. This we attribute to lower number of patients in this group and to the fact that the only fistula was through von Langenbeck palatoplasty by a less experienced surgeon. Experienced palatal surgeons recorded no fistula using intravelar veloplasty in this group. We acknowledge that this finding could be criticized due to the lower number of patients in the larger index group.

Some studies evaluated fistula rate by a single surgeon.[2],[22] This study evaluated fistula rate by different surgeons. Therefore, it tried to test the external validity of these repair techniques. This is so because a method of repair may be questionable if a single surgeon is performing a lot of operations accordingly with high success rate.[25]

Majority of surgeries were carried out by the experienced cleft surgeons. Their average is similar to that of an experienced American palate surgeon.[26]

Symptoms of 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.

These fistulae should be closed at some point to improve speech 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. 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.[2],[7],[27] While Landheer et al.[10] and Diah et al.[2] respectively report a recurrence rate of 9% and 25%, the recurrence rate of palatal fistulae reportedly approaches 100%.[8]

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. This junction which is generally the widest portion of a cleft,[21],[28] 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.[3] Furthermore, other than having inadequate muscle centrally, the site was noted to have the greatest tension at closure. This is especially so in wide palatal clefts with considerable soft tissue deficiency. Shah et al.[29] and Ogle[4] also observed that palatal fistula typically occur at the junction. However, de Agostino Biella Passos et al.[30] in a retrospective review found most fistulae in the anterior palate. Fistulae in the anterior palate are best avoided by careful suturing technique.[21]

The avoidance of oronasal fistula is a short term goal of palatoplasty while normal speech and normal maxillary growth are long term goals.[21] The first 4 weeks of repair is critical for the development of a secondary palatal fistula.[9],[21] Berkman[31] found all 11 fistulae within 10–14 days post palatoplasty and Shah et al.[29] diagnosed all fistulae within 3 weeks of surgery. Similarly, a significant number of fistulae were diagnosed in the 2nd week postoperative. By the 3rd 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.[4] High CPI alongside other factors may have occasioned the wound dehiscence that resulted in a few of the early fistulas in this study. According to Yong et al.[9] 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.[4],[22] No spontaneous healing of fistula was noted in our patients consistent with follow-up. Likewise in this prospective study, all fistulae developed within the first 3 weeks of repair. This underscores the need for adequate follow-up in the first 4 weeks postoperative.

Recommendations

The data encourage the use of intravelar veloplasty. The 0.26 palatal index should be the basis for choice of surgeon and parental counseling for the possibility of secondary fistula. There should be a strong interest in training and retraining of palate surgeons. Adequate follow-up especially in the first 4 postoperative weeks with emphasis on fluid diet are imperative. Finally, there should be more efforts at enlightenment campaigns to encourage early presentation to hospitals for cleft repair. In addition, 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 in our subregion.


  Conclusion Top


The results suggest that CPI is a strong factor in the development of oronasal fistula. The fistula rate increased as palatal index increased and the incidence of oronasal fistula was 41.30%. An index of 0.26 was associated with significant risk. The palatal index can be used for classification of cleft palate deformity and thus give an informed choice of an appropriate surgical technique and operating surgeon. Urgent steps are therefore needed to reduce this fistula rate in our subregion.

Acknowledgment

The authors thank all Residents and Staff who contributed to this study. We thank all patients who participated in this study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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