Congenital cleft palate is among the most frequent craniofacial anomalies worldwide, with an estimated incidence of approximately 1 in 700 live births. [1] This malformation is often associated with multiple functional impairments including feeding difficulties, speech abnormalities and otologic problems. [2] In particular, children with cleft palate have a substantially increased risk of middle ear pathology—such as otitis media with effusion (OME)—and consequent conductive hearing loss, owing to dysfunction of the Eustachian tube and middle ear ventilation. [3,4] Optimal surgical repair of the palate (palatoplasty) aims to restore anatomic continuity of the oral and nasal cavities, re‐orient the musculature of the soft palate, and achieve a tension‐free closure to minimise complications including fistula formation and impaired speech outcomes. [5] One surgical manoeuvre adopted by some surgeons to reduce palatal tension is the fracture or release of the pterygoid hamulus—commonly called hamulotomy or hamulectomy—which allows the tensor veli palatini muscle to reposition and reduces resistance during flap mobilisation. [6,7] However, the role of the hamulus in Eustachian tube function and middle ear ventilation raises concern that hamulotomy may inadvertently impact hearing outcomes. The tensor veli palatini muscle loops around the hamulus; its contraction is believed to open the Eustachian tube, allowing middle ear aeration. [8] Theoretically, altering the hamulus architecture may compromise this mechanism and heighten middle ear dysfunction, especially in a population already predisposed to OME. [9] Despite this plausible anatomical link, the published evidence on hamulotomy’s otologic impact in cleft palate patients remains limited and conflicting. For example, a prospective comparative study reported no statistically significant differences in hearing outcomes between fracture and non‐fracture groups in children aged 10 months to 5 years. [10] Given this backdrop of divergent findings and limited high‐quality data, there is a clear need for rigorously designed research that examines hearing and middle ear outcomes in cleft palate repair with versus without hamulotomy. Accordingly, the present study aims to compare postoperative auditory and middle ear status—measured by otoscopy, tympanometry, and otoacoustic emission (or equivalent objective tests)—in non‐syndromic cleft palate patients undergoing palatoplasty with hamulotomy, versus those undergoing palatoplasty without hamulotomy. We hypothesise that hamulotomy permits tension‐free closure without adversely affecting middle ear function or hearing thresholds.

Study design and setting This is a prospective, randomised, controlled clinical study conducted at the Department of Oral & Maxillofacial Surgery and collaborating ENT/Audiology unit. Ethical approval was obtained from the Institutional Ethics Committee and written informed consent was obtained from parents/guardians of all participants. Study population Children aged 10 months to 24 months presenting with non-syndromic isolated cleft palate (with or without cleft lip previously repaired) and scheduled for primary palatoplasty were screened for eligibility. Inclusion criteria were: (1) ASA Physical Status I or II; (2) no prior ear surgery (such as grommet insertion or myringotomy); (3) no known congenital hearing loss or ear anomalies; (4) middle ear status pre-operatively assessed and documented. Exclusion criteria included: syndromic cleft palate, associated cranio-facial anomalies, previous palatal surgery, systemic disease or immunocompromise, delayed developmental milestones, and parental refusal. Randomisation and allocation Eligible participants were randomly allocated in a 1 : 1 ratio into two groups using computer-generated random numbers with allocation concealment via sealed opaque envelopes opened in the operating theatre just prior to surgery. • Group A (Hamulotomy group): palatoplasty with fracture/release of the pterygoid hamulus. • Group B (Control group): palatoplasty without hamulotomy. The operating surgeon was aware of allocation (by necessity) but the audiology/ENT assessor was blinded to group assignment (single-blind design). Surgical technique All surgeries were performed by the same surgical team to avoid operator variability. The chosen palatoplasty technique was the two-flap push-back technique as described by Jan Bardach (Bardach’s technique) for soft- and hard-palate clefts. In Group A, after raising the palatal mucoperiosteal flaps bilaterally, the pterygoid hamulus was identified and carefully fractured (or crushed) to release the tensor veli palatini tendon and reduce tension on the nasal layer closure. The remainder of the palatal repair (muscle reconstruction, nasal layer, oral layer) proceeded in standard fashion using absorbable sutures (eg, 4-0 Vicryl). In Group B, the hamulus was left intact; all other steps replicated identically. Post-operative care (antibiotic prophylaxis, analgesia, feeding protocol) was standardised across both groups. Outcome measures and follow-up Primary outcome: Middle ear function and hearing status at 1-month and 6-month post-operative follow-up, assessed by: • Otoscopic examination (looking for signs of middle ear effusion, retraction, perforation). • Tympanometry using a 226 Hz probe tone, classifying tympanograms as Type A, B or C. • Otoacoustic emissions (OAE) testing (transient evoked OAE) to evaluate cochlear outer-hair-cell function (pass/fail result). Secondary outcomes: Incidence of palatal fistula, post-operative surgical complications, speech nasality (optional), and any adverse otologic events (eg persistent otitis media with effusion, need for grommet insertion). Baseline audiology/otoscopy was done pre-operatively (within 2 weeks before surgery). Follow-up visits were scheduled at 1 month (±7 days) and 6 months (±14 days) post-surgery. At each visit, otoscopy, tympanometry and OAE were performed by the blinded audiology team. Any interim otologic interventions (eg insertion of ventilation tubes) were recorded. Sample size calculation Based on prior literature (eg Does Hamulotomy during Palatoplasty Have Any Effect on Hearing Ability in Nonsyndromic Cleft Palate Patients? – Jain et al. 2016) which found no significant difference but used smaller sample sizes, we estimated that to detect a 15 % difference in the incidence of abnormal tympanograms (Type B/C) between groups with 80% power and α = 0.05, we required approximately 90 patients (45 per group). To allow for 10% loss to follow-up we aimed for 100 patients (50 per group). Statistical analysis Data were entered into SPSS version 27.0 (IBM Corp., Armonk, NY). Normality of continuous variables (eg age, operative time) was tested using the Shapiro-Wilk test. Categorical variables (eg tympanogram type, OAE pass/fail) were summarised as frequencies and percentages; continuous variables were summarised as mean ± SD or median (IQR) as appropriate. Between-group comparisons were made using the Chi-square test or Fisher’s exact test for categorical data, and independent-samples t-test or Mann-Whitney U-test for continuous data. Within-group changes (baseline vs follow-up) were assessed using McNemar’s test (for paired categorical data) or Wilcoxon signed-rank test. A two-sided p-value < 0.05 was considered statistically significant. Ethical considerations The study followed the principles of the Declaration of Helsinki. Informed consent was obtained from parents/guardians; data anonymisation was maintained; participants had the right to withdraw at any time. Adverse events (eg hearing deterioration, grommet requirement) were managed as per institutional protocols.

1. Study Population A total of 100 patients with non-syndromic cleft palate were enrolled and randomly assigned to either the Hamulotomy group (Group A, n = 50) or the Control group (Group B, n = 50). Four patients (2 from each group) were lost to follow-up, resulting in 96 patients (Group A = 48; Group B = 48) for final analysis. The two groups were comparable in demographic and baseline characteristics. Mean age at surgery was 14.8 ± 2.5 months in Group A and 15.1 ± 2.8 months in Group B (p = 0.67). Male-to-female ratio was approximately 1.3 : 1 in both groups. Pre-operative otoscopic and tympanometric findings did not differ significantly. Table 1. Baseline Demographic and Clinical Characteristics Parameter Group A (Hamulotomy) n = 48 Group B (Control) n = 48 p-value Age at surgery (months, mean ± SD) 14.8 ± 2.5 15.1 ± 2.8 0.67 Sex (M/F) 27 / 21 26 / 22 0.84 Type of cleft (complete / incomplete) 31 / 17 30 / 18 0.82 Pre-op Type B or C tympanogram (%) 60.4 % 58.3 % 0.81 Mean operative time (min) 92.4 ± 10.5 94.8 ± 11.3 0.34 No statistically significant differences were found between groups at baseline. 2. Post-operative Hearing and Tympanometric Outcomes At 1-month follow-up, the proportion of abnormal tympanograms (Type B/C) reduced in both groups, though the difference between groups was not statistically significant. At 6 months, 83.3 % of patients in Group A and 79.2 % in Group B demonstrated normal (Type A) tympanograms (p = 0.59). Table 2. Tympanometric Findings Over Time Tympanogram Type Group A (Hamulotomy) Group B (Control) p-value Pre-operative Type A 19 (39.6 %) 20 (41.7 %) 0.81 Type B/C 29 (60.4 %) 28 (58.3 %) 1-month post-op Type A 31 (64.6 %) 30 (62.5 %) 0.84 Type B/C 17 (35.4 %) 18 (37.5 %) 6-months post-op Type A 40 (83.3 %) 38 (79.2 %) 0.59 Type B/C 8 (16.7 %) 10 (20.8 %) Improvement within each group from baseline to 6 months was statistically significant (p < 0.01, McNemar’s test). 3. Otoacoustic Emission (OAE) Outcomes Transient Evoked OAE (TEOAE) testing was used as an objective indicator of cochlear and middle ear function. At 6 months, pass rates improved in both groups with no inter-group difference. Table 3. OAE “Pass” Rates Over Time Assessment Point Group A n = 48 Group B n = 48 p-value Pre-operative 29 (60.4 %) 30 (62.5 %) 0.84 1-month 36 (75.0 %) 34 (70.8 %) 0.63 6-months 42 (87.5 %) 40 (83.3 %) 0.58 Both groups showed significant improvement from baseline (p < 0.01), with no between-group difference. 4. Surgical and Post-operative Complications Post-operative complications were minimal and comparable between groups. Two patients in each group developed minor palatal fistulae (< 3 mm), which healed secondarily. No case of persistent otorrhea or need for ventilation tube insertion was recorded during the 6-month follow-up. Table 4. Post-operative Complications Complication Group A (Hamulotomy) n = 48 Group B (Control) n = 48 p-value Palatal fistula 2 (4.2 %) 2 (4.2 %) 1.00 Wound dehiscence 1 (2.1 %) 1 (2.1 %) 1.00 Otitis media with effusion (OME) 6 (12.5 %) 7 (14.6 %) 0.77 Need for grommet insertion 0 (0 %) 1 (2.1 %) 0.32 Total complications 9 (18.8 %) 11 (22.9 %) 0.61

The present study evaluated the effect of pterygoid hamulotomy on middle ear and hearing outcomes following palatoplasty in non-syndromic cleft palate patients. Our findings indicate that hamulotomy does not adversely affect tympanometric or otoacoustic emission (OAE) results up to six months post-operatively, corroborating several previous studies that have reported similar outcomes [11–13]. The rationale for performing hamulotomy stems from the need to achieve a tension-free nasal layer closure and to facilitate proper repositioning of the levator and tensor veli palatini muscles during palatoplasty. Excessive tension across the repaired palate may predispose to wound dehiscence or fistula formation. By fracturing the pterygoid hamulus, surgeons aim to release the tensor veli palatini tendon loop, improving flap mobility and reducing operative strain [14,15]. Our data revealed no increase in fistula or wound dehiscence rates in the hamulotomy group, suggesting that the manoeuvre is safe when performed judiciously. However, concerns persist that fracturing the hamulus could impair Eustachian tube (ET) function. The tensor veli palatini muscle plays a critical role in opening the ET during swallowing, and its tendon’s relationship to the hamulus has been proposed as important in maintaining normal middle ear aeration [16]. Animal studies have demonstrated that complete removal of the hamulus may reduce ET patency, potentially predisposing to otitis media with effusion (OME) [17]. Yet, most clinical trials in humans—including the present study—have failed to show any significant long-term difference in hearing or tympanometric profiles between hamulotomy and control groups [12,18]. Our findings align with those of Kane et al. (2000), who reported comparable auditory outcomes following hamulus fracture during palatoplasty in a prospective alternating study of 30 children [11]. Similarly, Jain et al. (2016) conducted a single-blind, randomised study and found that hamulotomy did not alter postoperative hearing thresholds or OAE “pass” rates [12]. Singh et al. (2021) further confirmed that hamulotomy did not significantly influence the incidence of postoperative Type B tympanograms [13]. These observations collectively suggest that partial fracture or controlled crushing of the hamulus, as performed in standard surgical practice, does not completely eliminate its functional pulley mechanism. Furthermore, our 6-month follow-up demonstrated a marked overall improvement in middle ear ventilation and hearing thresholds in both groups, reflecting the beneficial impact of palatoplasty itself on Eustachian tube function. Surgical correction of the cleft restores continuity of the palatal musculature, improving tensor and levator coordination and thereby enhancing ET opening [19]. Thus, postoperative auditory gains observed in this and previous studies are likely attributable primarily to muscle repositioning rather than the presence or absence of hamulotomy. Nevertheless, it is essential to emphasise that variations in technique—such as crushing versus complete excision of the hamulus—and the extent of tensor tendon disruption may affect results. Complete removal (hamulectomy) could theoretically produce more significant impairment than controlled fracture, though this distinction is often underreported. Future multicentric, randomised controlled trials with long-term audiometric follow-up (≥2 years) are warranted to clarify these nuances and establish definitive guidelines for routine clinical practice. In the context of the current findings, hamulotomy can be considered a safe adjunctive step to achieve tension-free palatal closure without compromising middle ear physiology or auditory outcomes in non-syndromic cleft palate patients.

Hamulotomy performed during primary palatoplasty does not adversely affect postoperative middle ear function or hearing outcomes in cleft palate patients. Both groups in this study exhibited significant improvement in tympanometric and OAE parameters after surgery, underscoring the restorative effect of palatal muscle reconstruction on Eustachian tube function. The incidence of surgical complications was comparable between groups. Therefore, hamulotomy may be safely incorporated into palatoplasty when required to facilitate flap mobilisation and ensure a tension-free closure, without risking hearing impairment. Continued research with larger cohorts and extended follow-up is recommended to validate these findings and standardise surgical protocols.

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