A Randomised Controlled Trial on the Effect of Hamulectomy on Hearing Outcomes in Cleft Palate Patients - A Comparative Study

Abstract

Introduction: Cleft palate, a common congenital craniofacial defect, requires surgical repair and many surgical approaches have been employed for the same to reduce the risk of post-operative complications and improve outcomes. In order to achieve tension free closure, fracture of pterygoid hamulus has been advised. However, the effect of this manoeuvre on auditory functions remains debatable. The study was designed to evaluate the effect of hamulectomy on auditory function during the post-operative period after palatoplasty.

Materials and methods: The present study enrolled 100 participants aged 10 months-2 years with isolated cleft palate defect. They were randomly divided into two groups: palatoplasty with hamulectomy (n = 50) and palatoplasty without hamulectomy (n = 50). Hearing outcomes were evaluated using objective measures (otoscopy, tympanometry, and otoacoustic emission [OAE] tests) at 1-month and 6-month post-operative follow-up visits. The Chi-square test was used to analyse the data and significance level was kept at P ≤ 0.05.

Results: The findings of otoscopy, tympanometry and OAE tests were statistically similar between the two study groups (P > 0.05; Chi-square test) at both one month and six months follow-up visits. Another noteworthy observation was improvement in auditory function during follow-up period indicating recovery of middle ear function following palatoplasty.

Discussion: The addition of hamulectomy to the palatoplasty treatment may improve the hearing outcomes for cleft palate patients and can be adopted to achieve tension free closure.

Keywords: Audiometry; cleft palate; palatoplasty; randomized controlled trial.