Outcome analysis of palatoplasty in various types of cleft palate.

AIMS: To analyse the factors affecting clinical and functional outcome of Veau-Wardill-Kilner palatoplasty in various types of cleft palate.
MATERIALS AND METHODS: Demographic data were retrieved from case records and a detailed speech, language and hearing and an orthodontic analysis were carried out prospectively.
RESULTS: Mean age at operation was 2.7 years; whereas mean age at the time of evaluation was 6 years. Most of the patients (43.3%, 13/30) had a bilateral cleft lip and palate. The postoperative fistula had developed in 31% (4/13) of the patients with bilateral clefts and in 17% (1/6) and 9% (1/11) of the patients with left unilateral and isolated cleft palate respectively (P<0.05). Eight per cent (2/24) of the patients operated before 2 years of age developed a fistula as compared to 66.6% (4/6) of the patients who had undergone a repair after 2 years of age (P<0.01). Severe speech abnormality was seen in 33.4% of the patients having postoperative fistula as compared to 16.6% of non-fistula patients (P<0.05). Derangement of speech was found in 66.6% of the patients who had undergone surgery after the age of 2 years as compared to the patients (13%, 3/24) undergoing correction before 2 years of age (P<0.05). Hearing loss was seen most commonly in patients with bilateral cleft palate as compared to the other varieties (P>0.05). Tympanic membrane (TM) abnormalities were also more common in bilateral cleft patients (P<0.05). Mean maxillary arch length, arch circumference and maxillary inter-canine and inter-molar width were significantly reduced as compared to the control group (P<0.001).
CONCLUSIONS: Socially acceptable quality of speech can be achieved in more than 85% of the patients. The postoperative fistula is associated with poor speech; bilateral cleft and older age being the risk factors for fistula formation. Many patients require audiological surveillance even when asymptomatic. Maxillary growth is impaired in all the patients despite early surgery.

INTRODUCTION

Facial clefts have tremendous aesthetic and functional implications for the patients in their social interaction.[1] The functional goals of the cleft palate surgery are to facilitate normal speech and hearing without interfering with the facial growth.[2-5] In our study, we evaluated postoperative clinical and functional outcome in patients of different types of cleft palate utilizing Veau-Wardill-Kilner method of repair.

MATERIALS AND METHODS

All the consecutive patients of non-syndromic cleft palate with or without associated cleft lip, who had undergone repair of cleft palate by a single operator (JKM) in the Department of Paediatric Surgery, were studied for speech, hearing and maxillofacial growth. To ensure an adequate assessment and comparison with normal peers, the patients were at least 5 years old at the time of assessment, had normal milestones and none of the patients had undergone any pre- or post-surgical orthodontic procedures, orthognathic surgery or alveolar bone grafting. All the patients had undergone Veau-Wardill-Kilner repair using muscle dissection without a fracture of the hamulus. A detailed speech, hearing and orthodontic analysis was carried out prospectively.[6]

Hearing screening was done using a standard pure tone or play audiometry with Madsen OB-922 clinical audiometer. Impedance audiometry was carried out to rule out the middle ear problems using a Siemens SD-30 impedance audiometer. Pure tone audiometry findings were obtained for each ear for air conduction at frequencies of 250, 500, 1000, 2000, 4000 and 8000 Hz and bone conduction at 250, 500, 1000, 2000 and 4000 Hz.

Orthodontic measurements were done by taking an alginate dental impression of the upper jaw. Impression trays were introduced to the child by TSD (Tell, Show, and Do) technique. The study models were evaluated for various arch dimensions (arch length, inter-canine width, inter-molar width, and the arch circumference).

Data was entered and analyzed using SPSS (ver. 12). The significance of the differences in percentage level was assessed using Chi square and the ANOVA tests. The study was approved by the Institute ethics committee.

RESULTS

Fifteen patients (50%) were males and 15 (50%) were females. Most of the patients (24/30, 80%) underwent palatoplasty between 18-24 months of age. Only 20 % (6) of the patients were older than 2 years at the time of surgery. However, the mean age at operation was 2.7 years (range 1.5 years to 5 years) whereas the mean age at the time of evaluation was 6 years (range 5 years to 7 years). Majority (43.3%, 13/30) had a bilateral cleft lip and palate followed by isolated cleft palate (36.7%, 11 patients) and left cleft lip and palate (20%, 6 patients).

Six (20%) patients had postoperative palatal fistulas located posterior to the incisive foramen. The fistulas were located in the hard palate alone (4) or at the junction of hard and soft palate (2) [Figure 1]. The fistula had developed in 31% (4/13) of patients with bilateral clefts and in 17% (1/6) and 9% (1/11)of the patients with left sided unilateral and isolated cleft palate respectively (P<0.05). Four patients (66.6%) with a palatal fistula had nasal regurgitation for liquids and solids and 2 patients were asymptomatic. Eight per cent (2/24) of the patients operated before 2 years of age developed fistula as compared to 66.6% (4/6) of the patientswho had undergone a repair after 2 years of age (P<0.01). Severe speech abnormality was seen in 33.4% of the patients having postoperative fistula as compared to 16.6% of non-fistula patients (P<0.05). Most common amongst the speech abnormalities was nasal emission or turbulence. Conductive hearing loss was seen in 66.6% (4/6) of the patients having a palatal fistula as compared to 50% (12/24) of the patients without a fistula (P>0.05).

Figure 1

Postoperative palatal fistula

Overall poor speech was observed in 17% of the patients [Table 1]. Severe speech abnormality was more common in patients with bilateral cleft (30.7%) as compared to the left sided (16.6%) or isolated cleft patients (9%) (P>0.05). Poor quality of speech was found in 4 out of 6 (66.6%) patients who had undergone surgery after the age of 2 years as compared to the patients (13%, 3/24) undergoing correction before 2 years of age (P<0.05). Two patients presented with ear discharge and 6 patients had recurrent upper respiratory tract infections. However on audiological assessment, 50% (30/60 ears) of the patients had hearing loss. The hearing loss, in all the cases, was characteristically conductive except in 2 cases that had sensori-neural deafness. In our study, the most affected frequency in pure tone audiometry was at 8000 Hz followed by 4000 and 500 Hz [Table 2]. Hearing loss was seen most commonly in patients with bilateral cleft palate (19/26 ears, 73%) as compared to isolated (13/22 ears, 59%) or left side cleft palate involvement (6/12 ears, 50%) (P>0.05).

Table 1

Quality of speech according to grading

Table 2

Average hearing level (dB) at each frequency

Retraction and perforation of the tympanic membrane were seen in 65% of the ears examined. Almost half of the patients showed grade-1 retraction of the tympanic membrane and the remaining patients had grade-2 retraction. Tympanic membrane (TM) abnormality was most commonly seen in the bilateral cleft patients as compared to the other two types of clefts (P<0.05) [Table 3]. Normal tympanogram (Type-A) was found in 33.3% of the patients. The stapedial reflex was present in 50% of the patients only.

Table 3

Tympanic membrane pathology and the type of cleft

The dental parameters were measured directly from the alginate model. Maxillary inter-canine and inter-molar distances were used to assess the degree of transverse maxillary collapse anteriorly at inter-canine level and posteriorly at inter-molar level. A control group was formed from a study conducted in normal patients of same age group and demographic location (Ketheneni Balaji Naidu thesis-April 2003) in our institute.

Mean maxillary arch length, arch circumference and inter-canine and inter-molar width in males as well as females was reduced as compared to the control group and this difference was statistically highly significant (P<0.001) [Table 4]. All of the above-mentioned 4 parameters were most affected in patients of bilateral cleft as compared to the isolated or left cleft palate patients [Table 5].

Table 4

Indicators of maxillary growth in control and study groups

Table 5

Comparison of dental parameters in various types of cleft palate

DISCUSSION

Despite advances in the field of cleft surgery, surgical repair alone cannot solve the multitude of problems encountered in patients with cleft lip and palate. The most debated issue has been how to achieve an optimal speech development with normal maxillary facial growth after repair in a cleft patient. The technique of pushback palatoplasty aims to achieve good velopharyngeal function and hence improved speech and audiological outcome, however the effects on the facial growth can be unexpected.

Cleft palate is associated with 85% of the bilateral lip defects as compared to 70% of the unilateral cleft population. In our study, bilateral cleft lip and palate was the most common anomaly (43.3%) as compared to isolated cleft palate (36.7%) and unilateral cleft lip and palate (20%). This may indicate that the majority of our patients belonged to the severe anatomical category defect.

The timing of cleft palate repair has significant effect on speech. It has been argued that earlier repair benefits the speech development as the speech process in some children begins at 1 year of age. Conversely, the late repair theoretically allows for a proper maxillo-facial growth because the transverse facial growth is not complete until 5 years of age.[2] This has led to a variety of timing protocols at different institutions and the optimal time of palatoplasty remains scientifically unproven. However, the best speech results are obtained when palate is closed near the time of the infant's initiation of language acquisition; thus, a primary palatoplasty before 2 years of age has become the norm.[278]

For all of our patients, Veau-Wardill-Kilner or V-Y pushback repair was used. There has been increased interest in the manipulation of levator palatine muscle to gain the palatine length. The gain in the palatine length due to push back is at the cost of denuding palatine bone anteriorly, with a possible adverse effect on the mid-facial growth.[2] However, a satisfactory long term mid-facial growth has been reported to occur with proper use of V-Y push back repair.[9] Sommerlad has described a radical dissection technique for retropositioning of the muscles.[1011]

The incidence of palatine fistula formation after palatoplasty varies from 0% to 25%.[12] In our study, 6 (20%) of the 30 patients developed fistula posterior to the incisive foramen although, this rate is slightly higher, but it is comparable with many other studies.[13] The patients, who underwent repair before 2 years of age had a lower incidence of fistula formation. The probable reason could be increased pliability of the palatine tissues in younger age.[14] On the other hand, age at the time of palate closure does not seem to affect the rate of fistula formation significantly in a study by Sadove et al.[15] In our study, laterality of the cleft showed a significant relationship with the fistula formation as bilateral clefts had a higher rate of fistula formation. However, some of these findings may be influenced by the small sample size. Fistula may become symptomatic resulting in nasal regurgitation, lodgment of food particles and poor speech.[16] Four of our patients complained of regurgitation of liquids and solids and 33% of the patients had severe speech abnormalities which were significantly more as compared to the non-fistula patients. Most common speech abnormality associated with the palatine fistula in our patients was nasal emission or nasal turbulence. Palatine fistulas are associated with increased incidence of middle ear effusion and the conductive hearing loss which was seen in two thirds of our patients with palatine fistula as compared to 50% of the non-fistula patients.

Children born with the palatine cleft required regular speech evaluation starting from the first year of life and often continuing into the adulthood.[317] Almost 50% of our patients had absent or mild hypernasality, 66% had none or mild nasal emission or nasal turbulence, 75% had no or mild grimace. Overall poor speech was observed in 16.6% (6) patients as per the grade of intelligibility and severity of the defect and age has emerged to be the major factor affecting speech in our study. Similar findings have been reported in a few recent studies.[17-19]

Otitis media in the cleft palate patients is virtually universal.[3] Only 2 (6%) of our patients had ear discharge as compared to a large number of patients suffering from ear complaints in other studies.[320] Twenty percent of our patients had recurrent upper respiratory tract infection which in turn would have contributed to poor middle ear function.In our study, ear pathology was seen in 50 % of the ears examined and the incidence of hearing loss was highest in bilateral clefts (73%) and in patients who were operated after 2 years of age (75%). Ignoring the middle ear may impair a child's ability to develop normal speech and language.[22] However in our study; it did not have a significant correlation, probably, because of the lower magnitude of hearing loss. Unlike the children without clefts, otitis media in cleft patients has a prolonged recovery and a substantial incidence of late sequelae.[23]

Palatoplasty has a detrimental effect on the maxillary growth.[2425] In our study, the growth of the maxillary arch was most affected in the patients with bilateral cleft followed by isolated and left cleft palate patients. Maxillary circumference was wider in control group at all levels as compared to the study group.

Therefore, the chosen method of palatoplasty should lay a greater emphasis on the speech development as it is far more difficult to establish a normal speech in older children after cleft palate repair than to correct the occlusion defects with orthodontic treatment. Socially and educationally acceptable quality of speech can be achieved in more than 85% of the patients especially when operated before 2 years of age. Many of these patients require audiological surveillance even when asymptomatic to further improve the speech output. Maxillary growth is impaired in all the patients despite early surgery.