Repaired Cleft Palate and Ventilation Tubes and Their Associations with Cholesteatoma in Children and Adults

Objective To evaluate the characteristics of children with cleft palate associated with persistent otologic issues in the first 10 years of life. Study Design Case series with chart review. Setting Single academic center. Subjects and Methods Children born with cleft palate from 2003 to 2007 and treated by the UC Davis Cleft and Craniofacial Team between January 2003 and December 2017 were included in the study. Data from 143 patients were analyzed via Wilcoxon rank sum and Fisher exact tests for univariate analysis and logistic regression to determine adjusted odds ratios. Results The median length of follow-up was 9.9 years, and the age at last ear examination was 10.7 years. At the last evaluation, unresolved otologic issues were common, with at least 1 ear having a tympanic membrane (TM) perforation (16.1%), a tympanostomy tube (36.2%), or conductive hearing loss (23.1%). After adjusting for demographic and clinical characteristics, history of palate revision or speech surgery was associated with having a TM perforation (P = .02). The only clinical variables associated with conductive hearing loss was the presence of a TM perforation (P < .01) or a genetic abnormality (P = .02). Severity of palatal clefting was not associated with specific otologic or audiologic outcomes after adjusting for other characteristics. Conclusion A large proportion of children with cleft palate have persistent otologic issues at age 10 years and would benefit from continued close monitoring well after the age when most children have normalized eustachian tube function. Prolonged otologic issues were not found to be associated with cleft type.

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“…The long-term benefit is to prevent cholesteatoma, which was reported in cleft populations with rates as high as 15.5%. 9…”

Section: Discussionmentioning

confidence: 99%

“…1,2 The effects among older children have been known even longer; since the late 1800s, children with cleft palate have had higher reported rates of chronic otologic issues, including otitis media with effusion, hearing loss, tympanic membrane perforations, and cholesteatoma as compared with the general population. 3-10…”

mentioning

confidence: 99%

Children with Cleft Palate: Predictors of Otologic Issues in the First 10 Years

Funamura

Lee

McKinney

et al. 2019

Otolaryngol.--head neck surg.

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“…Ponduri et al A further eight studies of children with CP have been included. 5,[79][80][81][82][83][84][85] In addition, the search was expanded to studies of children without CP or where the presence or absence of a cleft was not specified, this yielded a further 24 studies. [86][87][88][89][91][92][93][94][95][96][97][98][99][100][101][102][103][104][105][106][107][108][109] Studies did not always clearly state the primary outcome and when this was the case the primary outcome was inferred from the sample size calculation, the study title and/or the results presented first in the results section.…”

Section: Description Of Included Studiesmentioning

confidence: 99%

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation

Bruce

Harman

Williamson

et al. 2015

Health Technol Assess

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BackgroundCleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate.ObjectivesTo identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies.DesignThe management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP.SettingThe survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients’ homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting.ParticipantsClinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association.ResultsThe clinician survey revealed that care was predominantly delivered via a ‘hub-and-spoke’ model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research.ConclusionsThere exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered.FundingThe National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

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“…The underlying etiology in these patients is thought to be Eustachian tube dysfunction due to the abnormal insertion and poor function of the tensor veli palatini and levator veli palatini (Goudy et al, 2006). Complications of OME include conductive hearing loss, tympanic membrane (TM) retraction, tympanosclerosis, and chronic otitis media; these can in turn lead to delays in children's speech and language development as well as chronic middle ear problems that may persist into adulthood (Sheahan et al, 2002;Reiter et al, 2009). In children without clefts, middle ear disease often improves significantly after age 2, as growth results in morphological changes in the Eustachian tube leading to better function; however, these changes are seen later and less consistently in children with cleft palate (Sheahan et al, 2003;Tuncbilek et al, 2003).…”

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confidence: 99%

Evaluation of Ventilation Tube Placement and Long-term Audiologic Outcome in Children with Cleft Palate

Kim

Kanack

Dang-Vu

et al. 2017

The Cleft Palate-Craniofacial Journal

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While children with worse middle ear disease are more likely to receive more tubes and have long-term conductive hearing loss as a result of ear disease, the results of this study suggest that multiple tube placements may not contribute to improved long-term hearing outcomes. Further research focusing on long-term outcomes is needed to establish patient-centered criteria guiding decision making for ventilation tube placement in children with cleft palate.

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Repaired Cleft Palate and Ventilation Tubes and Their Associations with Cholesteatoma in Children and Adults

Abstract: Tube insertion had no influence on the development of cholesteatoma. Adults with submucous cleft palate especially require periodic otologic evaluation because they have Eustachian tube-related otologic disease and hearing loss at a higher rate than expected.

Cited by 24 publications

References 16 publications

Children with Cleft Palate: Predictors of Otologic Issues in the First 10 Years

Children with Cleft Palate: Predictors of Otologic Issues in the First 10 Years

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation

Evaluation of Ventilation Tube Placement and Long-term Audiologic Outcome in Children with Cleft Palate

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