Impact of Palatoplasty on Middle-Ear Effusion in Children with Cleft Lip and Palate

Abstract

Background:

Previous studies have primarily evaluated postoperative middle-ear outcomes following palatoplasty and ventilation tube insertion (VTI), with a focus on patient age and cleft severity. However, few have investigated the influence of cleft sidedness and variations in Furlow-based palatoplasty techniques. This study aimed to assess the presence of otitis media with effusion (OME) before and after palatoplasty, with or without VTI, and to identify factors associated with OME, including baseline patient characteristics, cleft sidedness, and surgical approach.

Methods:

The authors retrospectively analyzed 86 children with cleft palate or cleft lip and palate who underwent palatoplasty at their hospital from October of 2017 to December of 2021, with at least 2 years of follow-up evaluating middle-ear outcomes.

Results:

Age at palatoplasty date, sex, congenital anomalies, and cleft severity were not significantly associated with preoperative OME. Complete clefts showed a higher OME incidence than incomplete cleft palate in univariable analysis, but not in multivariable analysis. The use rate of Furlow palatoplasty combined with hard palate repair increased with increasing cleft severity. Neither the choice of palatoplasty technique nor cleft sidedness was significantly associated with the presence of OME before palatoplasty or with the development of OME after palatoplasty. Postoperative OME rates were similar between children with OME undergoing VTI and those without OME treated by palatoplasty alone.

Conclusions:

Cleft sidedness and surgical technique did not influence OME before or after palatoplasty. Ventilation tube insertion is beneficial for patients with OME but may be unnecessary in those without prior effusion.

Language development involves hearing, language comprehension, expression, and pronunciation, all of which are essential for effective language acquisition. Eustachian tube dysfunction in patients with cleft lip and palate, often caused by insertion loss and veli palatini muscle fusion issues, leads to otitis media with effusion (OME), affecting hearing.¹ Over 90% of patients with cleft palate experience at least 1 episode of OME before school age, and OME may persist or recur from infancy through age 5 years or beyond.^2,3 Current treatment includes palatoplasty and ventilation tube insertion at approximately 1 year of age to address OME during language development.^4–7

The choice of surgery for cleft palate repair varies depending on the surgeon’s experience and clinical considerations. The Furlow double-opposing Z-plasty and the Sommerlad straight-line palatoplasty are primarily used for soft palate repair, whereas the Bardach two-flap palatoplasty, von Langenbeck palatoplasty, and Veau-Wardill-Kilner pushback are commonly used for hard palate repair.^7–11 Furlow palatoplasty is a widely used technique because of its positive speech and hearing outcomes.^12,13 This technique improves soft palate length, reducing velopharyngeal insufficiency (VPI), but increases oronasal fistula (ONF) risk.⁴ Combining soft palate and hard palate repair techniques for primary cleft palate repair leads to more favorable speech function, a lower likelihood of VPI, and a lower ONF risk compared with the use of either technique alone.^4,14,15 Studies have focused on middle-ear outcomes postpalatal surgery and ventilation tube insertion (VTI), particularly the effects of cleft severity and patient age. In this study, we explored risk factors that influence middle-ear function before and after surgery and examined how cleft lip and palate orientation affects OME directionality. In patients with cleft palate or lip and OME, the term “same sidedness” refers to cases of right cleft lip and palate (RCLP) with right-ear OME, left cleft lip and palate (LCLP) with left-ear OME, bilateral cleft lip and palate (BCLP) with right-ear OME, and BCLP with left-ear OME. By contrast, the term “different sidedness” refers to cases of RCLP with left-ear OME and LCLP with right-ear OME.

PATIENTS AND METHODS

Study Design

This retrospective study included 300 children with cleft lip and palate who underwent Furlow-based palatoplasty for palate repair at our hospital from October of 2017 to December of 2021 (Fig. 1). We excluded 186 patients from other countries and those not followed up at our institution, and 28 patients lost to follow-up within 2 years. Of the remaining 86 patients, 17 did not undergo VTI, 9 underwent unilateral tube insertion, and 60 underwent bilateral tube insertion. A total of 172 ears were evaluated. This study was approved by our ethics committee (approval no. N202404114).

Fig. 1.

Retrospective analysis flowchart of the electronic medical records of patients with cleft palate included in this study. The detailed inclusion and exclusion criteria are listed.

Classification of Cleft Palate and Cleft Lip and Palate

Cleft palate is categorized as complete or incomplete cleft on the basis of the degree of palate fusion. Cleft severity was stratified using 2 criteria: the Veau classification (progressing from Veau I to Veau IV) and the extent of anatomical involvement. Anatomical severity was categorized in increasing order as follows: submucous cleft palate, isolated cleft palate, unilateral cleft lip and palate (UCLP) (including RCLP and LCLP), and BCLP. These classifications reflect increasing anatomical complexity and surgical difficulty. In patients with cleft palate or cleft lip and palate, congenital abnormalities such as maxillofacial deformities, systemic disorders, and genetic defects are documented.

Surgical Procedure for Palate Reconstruction

For patients with cleft palate or cleft lip and palate, surgical procedures are typically performed between the ages of 9 and 12 months at our institution. For patients with cleft lip and palate, surgical repair is often conducted in a 2-stage procedure of lip repair between 3 and 6 months of age, and this is followed by palate repair between 9 months and 1 year of age. Both lip and palate repair procedures are performed by Dr. Philip Kuo-Ting Chen at the Department of Plastic Surgery. The primary technique used for palate repair is Furlow palatoplasty, with potential consideration of the adjunctive Langenbeck or 2-flap procedure depending on the patient’s characteristics. In Furlow palatoplasty, the first step involves designing a Z-plasty. The oral mucosal flap, located anteriorly, is raised at an angle of 80 degrees to guide an incision for the posterior myomucosal flap. The levator muscles are dissected clearly through the space medial to the hamulus process. A similar technique is used to design a nasal-side Z-plasty. Another Z-plasty is performed posteriorly to the levator muscle to address length deficiencies in the right nasal mucosa. Finally, the levator muscle sling is reconstructed by carefully approximating the muscles from both sides.¹⁶ In this study, 2 modified Furlow palatoplasty techniques were used, each combined with 1 of 2 hard palate closure methods: Bardach 2-flap palatoplasty and von Langenbeck palatoplasty. The Bardach 2-flap palatoplasty involves extending lateral incisions along the anterior secondary palate to converge at the incisive foramen, followed by elevating the bilateral unipedicled mucoperiosteal flaps from the hard palate, which are vascularized by the greater palatine arteries.¹⁷ In von Langenbeck palatoplasty, bipedicled mucoperiosteal flaps are created by performing lateral relaxing incisions on the soft and hard palate’s lateral areas on the palatal side.¹⁸

Diagnosis and Treatment of OME

OME, diagnosed in accordance with updated clinical guidelines, is caused by the accumulation of fluid in the middle ear, resulting in hearing loss without structural damage to the tympanic membrane.¹⁹ Establishing a diagnosis of OME necessitates integration of the findings of otoscopy and tympanometry procedures conducted by an experienced otolaryngologist. According to the 2022 Clinical Practice Guidelines for the Diagnosis and Management of OME in Children in Japan, children with cleft palate are considered at high risk for persistent OME and its complications.¹⁹ The guidelines recommend considering VTI to manage OME and prevent associated hearing loss in such cases. In our institution, the presence of tympanic membrane abnormalities on otoscopic examination combined with a type B tympanogram is considered an indication for VTI. In exceptional cases, such as patients from regions with limited access to health care or those with a history of recurrent OME, we may consider prophylactic VTI even in the absence of active effusion. These decisions are made individually following thorough discussions with the patient’s family before surgery. To minimize the number of surgical procedures and anesthesia exposures, we routinely perform VTI concurrently with palatoplasty. During surgery, ventilation tubes are inserted into the anterior inferior quadrant of the tympanic membrane through otomicroscopy. These tubes are maintained until their spontaneous extrusion. The condition of the tympanic membrane and ventilation tubes was assessed at each follow-up using otoscopy. Middle-ear outcomes in this study, including the occurrence of new-onset OME after palatoplasty and the recurrence of OME during follow-up, were comprehensively documented. During the study period, 6 otolaryngologists (Che-Hsuan Lin, MD, PhD, Shing-der Hsu, MD, Shih-Han Hung, MD, PhD, Yen-Chun Chen, MD, Tzu-Ying Chen, MD, and Ting-So Chang, MD) participated in the preoperative evaluation, VTI, and postoperative follow-up of patients.

Statistical Analysis

Statistical analyses were conducted using R software (version 4.0.4). Continuous variables were analyzed using t test or analysis of variance; categorical variables were compared using chi-square or the Fisher exact test. Post hoc tests evaluated cleft severity and surgical procedure types. Univariable and multivariable logistic regression analyses identified factors influencing OME prevalence. A value of P < 0.05 was considered statistically significant. The potential impact of cleft sidedness on the laterality of OME was assessed using a Bayesian approach.

RESULTS

Patients’ Characteristics

Table 1 presents the demographic characteristics of the 86 patients, divided into 3 groups: no VTI, unilateral tube insertion, and bilateral tube insertion. Baseline conditions, including sex ratio, family history, associated anomalies, cleft palate type, and age at palatoplasty, were similar across groups. Most patients were classified as Veau grade II or III, with a 3:2 ratio of complete to incomplete cleft palate. According to a correlation analysis of palatoplasty technique, Veau classification, cleft palate type, and cleft completeness or incompleteness (Fisher exact test), the type and severity of cleft palate determined whether hard palate repair techniques were required in addition to Furlow palatoplasty (Table 2). (See Table, Supplemental Digital Content 1, which shows palatoplasty versus types of cleft palate abnormality, https://links.lww.com/PRS/I350. See Table, Supplemental Digital Content 2, which shows palatoplasty versus cleft palate completeness or incompleteness, https://links.lww.com/PRS/I351.) The Holm post hoc analysis revealed significant differences in palatoplasty techniques depending on cleft grade and severity. Cases of hard or complete cleft palate required Furlow palatoplasty combined with von Langenbeck or 2-flap palatoplasty. In cases of BCLP, corresponding to Veau grade IV, the likelihood of requiring Furlow palatoplasty combined with two-flap palatoplasty was higher than that of requiring Furlow palatoplasty only or Furlow palatoplasty combined with von Langenbeck palatoplasty.

Table 1.

Demographic Characteristics of Patients Who Underwent Palatoplasty

Characteristic	Total (%)	Patients with No Ventilation Tube Insertion (%)	Patients with Ventilation Tube Insertion in a Single Ear (%)	Patients with Ventilation Tube Insertion in Both Ears	P
No. of patients	86	17	9	60
Sex					0.66
Boy	42 (48.9)	9 (52.9)	3 (33.3)	30 (50)
Girl	44 (51.1)	8 (47.1)	6 (66.7)	30 (50)
Family history					0.1105
Yes	4 (4.7)	2 (11.8)	1 (11.1)	1 (1.7)
No	82 (95.3)	15 (88.2)	8 (88.9)	59 (98.3)
Associated anomaly 1					0.6013
Maxillofacial anomaly complex	8 (9.3)	1 (5.9)	0 (0)	7 (11.7)
No maxillofacial anomaly complex		16 (94.1)	9 (100)	53 (88.3)
Associated anomaly 2					1
Systemic disorder	9 (10.5)	2 (11.8)	1 (11.1)	6 (10)
No systemic disorder		15 (88.2)	8 (88.9)	54 (90)
Cleft palate type
Veau classification					0.7611
Grade I	10 (11.6)	3 (17.6)	1 (11.1)	6 (10)
Grade II	29 (33.7)	6 (35.3)	3 (33.3)	20 (33.3)
Grade III	37 (43)	5 (29.4)	5 (55.6)	27 (45)
Grade IV	10 (11.6)	3 (17.6)	0	7 (11.7)
Cleft palate disease
LCLP	21 (24.4)	2 (11.8)	4 (44.4)	15 (25)	0.7899
RCLP	16 (18.6)	3 (17.6)	1 (11.1)	12 (20)
BCLP	10 (11.6)	3 (17.6)	0	7 (11.7)
ICP	35 (40.7)	8 (47.1)	4 (44.4)	23 (38.3)
SCP	4 (4.7)	1 (5.9)	0	3 (5)
Cleft palate completeness or incompleteness					0.3039
Complete	51 (59.3)	8 (47.1)	4 (44.4)	39 (65)
Incomplete	35 (40.7)	9 (52.9)	5 (55.6)	21 (35)
Mean age at surgery ± SD, mo	11.99 ± 4.55	12.73 ± 3.58	11.34 ± 2.13	11.92 ± 5.03

ICP, isolated cleft palate; SCO, submucous cleft palate.

Table 2.

Palatoplasty versus Cleft Palate Severity^a,b

Characteristic	Veau Type
Palatoplasty	I	II	III	IV
Furlow palatoplasty alone	10	8	16	1
Furlow palatoplasty plus von Langenbeck palatoplasty	0	16	12	0
Furlow palatoplasty plus 2-flap palatoplasty	0	5	9	7
Two-flap palatoplasty alone	0	0	0	2

^aHolm post hoc analysis: significant difference detected in the following three 2 × 2 matrices: Veau grades I and II versus Furlow palatoplasty alone and Furlow palatoplasty plus von Langenbeck palatoplasty, Veau grades I and IV versus Furlow palatoplasty alone and Furlow palatoplasty plus 2-flap palatoplasty, and Veau grades II and IV versus Furlow palatoplasty plus von Langenbeck palatoplasty and Furlow palatoplasty plus 2-flap palatoplasty.

^bP = 0.0004998; Fisher exact test.

OME before Palatoplasty

Given that the decision to perform VTI during palatoplasty depends on whether the patient has a history of OME before surgery, it was not included in the analysis of risk factors for OME before surgery, particularly because VTI is regarded as a human-modifiable factor. Comparisons of UCLP and BCLP only include patients with Veau grade III or IV. In this study, because of the smaller number of ears in this group compared with the total number of ears, we did not include UCLP or BCLP in our multivariable analysis. Univariable and multivariable analyses showed no significant effect of sex, age, associated anomalies, cleft type, or cleft completeness on OME before palatoplasty. (See Table, Supplemental Digital Content 3, which shows variables affecting initial middle-ear status and outcomes in 172 ears in patients who underwent palatoplasty, https://links.lww.com/PRS/I352.) Considered together, cleft severity and type, not OME history, determined the need for additional hard palate repair techniques. (See Table, Supplemental Digital Content 4, which shows palatoplasty versus OME, https://links.lww.com/PRS/I353.)

OME after Palatoplasty

There was no significant difference in postoperative OME rates between patients who underwent palatoplasty with or without VTI. Univariable analysis showed that complete cleft palate was linked to higher postoperative OME rates, but multivariable analysis revealed no significant difference, likely because of other influencing factors. In addition, the factors discussed earlier had no significant effect on postoperative OME development (see Table, Supplemental Digital Content 3, https://links.lww.com/PRS/I352). Analysis of postoperative OME rates in 4 patient groups—Furlow palatoplasty alone, Furlow palatoplasty plus von Langenbeck palatoplasty, Furlow palatoplasty plus two-flap palatoplasty, and two-flap palatoplasty alone—revealed a value of P < 0.05 (Fisher exact test). However, Holm post hoc analysis revealed no significant differences in any of the aforementioned 2 × 2 matrices. No significant difference was found in postoperative OME rates between patients who underwent Furlow palatoplasty alone and those who underwent Furlow palatoplasty combined with a hard palate repair technique. Subgroup analysis of patients who underwent palatoplasty combined with VTI revealed that the surgical technique used did not have a significant effect on postoperative OME rates (see Table, Supplemental Digital Content 4, https://links.lww.com/PRS/I353). Among the 16 patients with unilateral OME before surgery, 13 had no recurrence, 2 had contralateral recurrence, and 1 had bilateral recurrence. Because of the small sample, only descriptive statistics were available. Overall, our results do not reveal a significant correlation between recurrent OME after surgery and the primary ear in patients with unilateral OME before palatoplasty. (See Table, Supplemental Digital Content 5, which shows OME recurrence in the same or a different ear, https://links.lww.com/PRS/I354.)

OME versus Cleft Sidedness

Only patients with UCLP and BCLP were included in the analysis of the relationship between cleft sidedness and OME (Fig. 2). Data were analyzed for patients who underwent either palatoplasty alone or palatoplasty combined with VTI. Preoperative analysis showed that the proportion of OME occurring on the same side as the cleft was 0.77, whereas the proportion occurring on the opposite side was 0.76, with no significant difference (P = 1). The postoperative OME rates on the same side as the cleft was 0.25, whereas it was 0.19 on the opposite side, with no significant difference (P = 0.7). In patients who underwent VTI, the directionality of postoperative OME after tube placement was not significantly associated with cleft sidedness (P = 1). (See Table, Supplemental Digital Content 6, which shows cleft sidedness versus OME, https://links.lww.com/PRS/I355.) Using posterior estimation with uniform priors, we compared the proportion of OME on the same versus the opposite side of the cleft (44 of 57 versus 28 of 37). The resulting posterior distribution of the proportion difference showed that 73.4% of the estimates fell within a ±10% equivalence margin, suggesting any difference is likely minimal and clinically negligible. Furthermore, the posterior probability favored OME occurring on the same side in 57.9% of cases versus 42.1% on the opposite side, indicating a mild directional trend without strong statistical support. These results indicate that cleft sidedness does not meaningfully influence OME occurrence before or after palatoplasty, regardless of whether VTI was performed.

Fig. 2.

Posterior distribution of the proportion difference between same-sided and opposite-sided OME in cleft lip and palate patients. The red dashed lines indicate the ±10% clinical equivalence margins. The majority of posterior estimates are centered around 0, with 73.4% falling within the equivalence range, supporting the conclusion that cleft sidedness does not meaningfully influence OME laterality.

DISCUSSION

OME Prevalence and Risk Factors

The first 2 years of life are crucial for language development. Approximately 90% of patients with cleft palate experience OME; this percentage is significantly higher than that in children without cleft palate.^1,20–24 Studies have not shown a significant trend in OME incidence before surgery with the Veau classification. Although the incidence of OME before palatoplasty is higher when the cleft width is greater, no correlation has been discovered between cleft width and the Veau classification.^19,25 In this study, preoperative OME did not correlate with age, sex, associated abnormalities, or cleft severity.

Surgical Technique and Functional Outcomes

Studies have indicated that cleft palate involving the hard palate or alveolar ridge, or wide cleft width—when combined with soft palate repair and hard palate relaxing incisions, local flaps, or buccal flaps—results in more favorable speech outcomes and lower likelihood of ONF and VPI after palatoplasty.^14,15,25 Scholars have also indicated that, with increasing Veau classification from low to high, a trend can be observed in the choice of primary palate repair technique, progressing from straight-line palatoplasty to von Langenbeck or 2-flap palatoplasty.²⁶ Our study indicated that as the Veau classification increased, there was a higher incidence of Furlow palatoplasty combined with von Langenbeck or 2-flap palatoplasty. These findings suggest that, compared with incomplete clefts, complete clefts are more likely to require a combination of soft and hard palate repair techniques. In addition, the choice of palatoplasty technique, however, is not influenced by cleft sidedness (unilateral versus bilateral).

Surgical outcomes, including ONF, VPI, and speech function, have been widely studied in relation to different palatoplasty techniques.²⁷ Compared with intravelar veloplasty, Furlow palatoplasty is associated with a lower likelihood of hoarseness, nasal escape, and hypernasality and more favorable speech outcomes compared with von Langenbeck palatoplasty.^28–31 Furlow palatoplasty is associated with excellent outcomes in terms of nasal resonance and speech intelligibility at 6 months after surgery, and by 3 years of age, it yields similar speech outcomes to those of 2-flap palatoplasty.^32,33

Although the severity of cleft palate based on Veau classification does not influence preoperative OME incidence, greater cleft length and width may require additional procedures to relieve mucomuscular tension in both the hard and soft palates.³⁴ Our study shows that severe clefts treated with relaxing incisions to reduce tension and align the cleft site resulted in similar postoperative OME rates, regardless of whether patients underwent Furlow palatoplasty alone, Furlow combined with von Langenbeck surgery, or 2-flap palatoplasty. These findings suggest that managing mucosal and muscular tension positively impacts palatal muscle and eustachian tube function. We compared the outcomes of Furlow palatoplasty alone and combined with hard palate repair, and a subgroup of patients who underwent palatoplasty with VTI. Our results showed no significant difference in postoperative OME rates between different techniques. According to the literature, lateral relaxing incisions, while beneficial for maxillofacial growth and reducing ONF risk, can lead to adverse effects such as palatal bone denudation, contributing to maxillary dysgenesis.^7,35 Buccal fat flaps help mitigate these complications by covering the lateral alveolar side.⁵ A 2019 systematic review of 5 studies discussed the differences in the incidence of postoperative OME between various primary palatoplasty techniques. Four of these studies revealed no significant difference in postoperative OME outcomes between different primary cleft repair techniques, including Furlow palatoplasty versus 2-flap palatoplasty, von Langenbeck palatoplasty versus straight-line palatoplasty, and intravelar veloplasty versus 2-flap palatoplasty. Only 1 study reported that intravelar veloplasty was associated with a lower incidence of postoperative OME than was 2-flap palatoplasty.³⁶ In our study, we discovered that cases of severe cleft palate typically required hard palate repair in addition to Furlow palatoplasty. However, we discovered no significant difference in the incidence of postoperative OME between different surgical techniques.

Timing and Effectiveness of VTI

Given the high prevalence of OME among patients with cleft palate during their language development period, the majority of studies have indicated that VTI can help improve their hearing, speech, language, and cognitive development and support continual aeration of the mastoid.^23,37,38 However, no consensus exists regarding the optimal timing of VTI, before, during, or after palatoplasty. To reduce surgical and anesthetic procedures, we performed palatoplasty combined with VTI for patients diagnosed with OME before surgery. A small number of patients without OME also underwent VTI, whereas some with OME did not, mainly because of parental considerations. Tube insertion is generally recommended before the age of 2 years, primarily because this is the key period of language development that has a high risk of OME. Several guidelines recommend routine audiologic assessments and tympanic membrane monitoring postoperatively, with follow-up visits every 4 to 6 months and long-term follow-up until the eustachian tube is fully functional.^19,39,40 The decision to insert unilateral or bilateral ventilation tubes should be carefully considered in patients with cleft palate and OME. In our study, the postoperative OME rates did not differ significantly between patients without OME preoperatively who did not undergo VTI and those with OME who underwent tube insertion, suggesting that VTI improves outcomes in OME patients, whereas non-OME patients do not require tube insertion. Furthermore, no significant difference was discovered between the long-term hearing outcomes of patients who underwent multiple tube insertion procedures and those who underwent a single procedure. Therefore, patients who experience OME relapse after ventilation tube removal typically require reinsertion of a ventilation tube.^41,42

Influence of Cleft Severity and Classification

Unlike for the incidence of OME before palatoplasty with a change in cleft palate severity, a trend has been found toward a higher rate of OME recurrence with a higher Veau grade, particularly with complete clefts being more often affected than incomplete clefts.^43–45 We also found that a higher Veau grade was associated with a higher rate of postoperative OME, particularly in complete clefts. However, multivariable analysis showed no significant difference, likely because of other influencing factors examined in this study, including age at palatoplasty, presence of congenital anomalies, and sex. A retrospective study published in 2019 suggested that cleft palate patients older than 1 year who underwent concurrent palatoplasty and VTI demonstrated better audiologic outcomes compared with those younger than 1 year.⁴ In contrast, a 2022 retrospective study reported that neither the type of OME nor the age at first tympanostomy tube placement was significantly associated with OME recurrence.⁴³ Consistent with these findings, our study showed that age at palatoplasty and the presence of combined maxillofacial or systemic abnormalities did not correlate with postoperative OME incidence.

Cleft Sidedness and OME Laterality

Our findings indicate that cleft sidedness does not influence the presence of OME before palatoplasty or the development of OME after palatoplasty. Insertion of the palatal muscles at the midline of the soft palate can result in varying degrees of dysfunction, regardless of cleft direction. Both the bilateral tensor and levator veli palatini muscles may experience insufficiency because of improper muscle insertion and tension. Furlow palatoplasty realigns these muscles across the palate, forming a functional muscular sling. This rebalancing of palatal muscle tension may explain why postoperative OME is not correlated with cleft sidedness.

Postoperative Monitoring

To our knowledge, few studies have specifically explored whether children with unilateral OME are more prone to recurrence in the same ear or in the contralateral ear after treatment. With our limited data, we were unable to demonstrate a significant correlation between OME recurrence after surgery and primary ear in patients with cleft palate who received a diagnosis of unilateral OME before palatoplasty. Given these findings, both ears should be comprehensively examined for middle-ear conditions during postoperative follow-up.

Limitations

This single-center retrospective study was conducted by a single surgeon, which controlled for intersurgeon variability but also made surgical outcomes dependent on the surgeon’s experience and judgment. Our hospital’s craniofacial center started treating cleft palate patients in 2017, meaning that long-term follow-up will require additional time. In our current data set, cleft width was not consistently recorded and was therefore not included in the analysis. We have recently begun prospectively recording cleft width in new patients and plan to investigate its association with clinical outcomes in future studies. Although this Bayesian framework avoids binary conclusions inherent in P value interpretation, the moderate sample size still results in a wide posterior distribution, limiting the strength of inference.

CONCLUSIONS

Age at palatoplasty, sex, congenital abnormalities, and cleft severity do not significantly affect the likelihood of OME before surgery. Univariable logistic regression showed that complete cleft palate is associated with higher postoperative OME rates compared with incomplete cleft palate. However, multivariable regression analysis found no difference, likely attributable to other influencing factors. Severe cleft palate often requires Furlow palatoplasty combined with hard palate repair, but neither the surgical technique nor cleft sidedness significantly correlates with OME before or after surgery. Furthermore, OME diagnosis before palatoplasty and combined VTI does not differ in postoperative OME rates from children without OME diagnosis. These findings suggest that VTI improves middle-ear outcomes for patients with OME, whereas those without OME do not require tube insertion.

DISCLOSURE

The authors declare that there are no conflicts of interest to disclose. No financial support or funding was received for this study.