Timing of Primary Surgery for Cleft Palate.

BACKGROUND: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. METHODS: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESULTS: We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up. CONCLUSIONS: Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).

Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS).

Canonical babbling (CB) is commonly defined as present when at least 15% of all syllables produced are canonical, in other words a canonical babbling ratio (CBR) ≥0.15. However, there is limited knowledge about inter-rater reliability in classification of CB status based on CBR and inter-rater differences in assessment of CBR. We investigated inter-rater reliability of experienced Speech Language Therapists (SLTs) on: classification of CB status based on CBR ≥ 0.15, CBRs and the total number of syllables per infant used to calculate CBR.Each infant (n = 484) was video-recorded at a clinical site in play interaction with their parent as part of the randomised controlled trial Timing of Primary Surgery for Cleft Palate. Each recording was subsequently assessed by three independent SLTs, from a pool of 29 SLTs. They assessed the recordings in real time.The three assessing SLTs agreed in classification of CB status in 423 (87.4%) infants, with higher complete agreement for canonical (91%; 326/358) than non-canonical (77%; 97/126). The average difference in CBR and total number of syllables identified between the SLT assessments of each infant was 0.12 and 95, respectively.This study provided new evidence that one trained SLT can reliably classify CB status (CBR ≥ 0.15) in real time when there is clear distinction between the observed CBR and the boundary (0.15); however, when the observed CBR approaches the boundary multiple SLT assessments are beneficial. Thus, we recommend to include assessment of inter-rater reliability, if the purpose is to compare CBR and total syllable count across infants or studies.Trial registration number here: www.clinicaltrials.gov, identifier NCT00993551.

Avaliação audiológica pré-cirurgia otológica de indivíduos com fissura labiopalatina operada / Pre-surgical auditory assessment of subjects with operated cleft lip and palate

OBJETIVO: descrever as características audiológicas de indivíduos com fissura labiopalatina operada (FLP) e indicação de cirurgia otológica, comparando os grupos quanto ao tipo e grau da perda auditiva, bem como a curva timpanométrica. MÉTODOS: análise de 150 prontuários, ambos os gêneros, idade igual ou superior a 4 anos, FLP e indicação de cirurgia otológica, divididos em 3 grupos: I - Tubo de ventilação (TV), II - Timpanoplastia e III - Timpanomastoidectomia, analisando aspectos quanto a entrevista audiológica, audiometria tonal limiar e imitanciometria. RESULTADOS: o grupo I apresentou porcentagem maior de cirurgia bilateral (86 por cento), o que não ocorreu nos demais grupos. Na entrevista audiológica, 83 por cento apresentou algum tipo de queixa auditiva, sendo a mais frequente a perda auditiva (64 por cento) com p<0,05 entre os grupos I e II; I e III. O tipo de perda auditiva de maior ocorrência foi condutivo bilateral (56 por cento) seguido de unilateral (35 por cento), com p<0,05 entre os grupos I e II; I e III. A perda de grau leve unilateral foi a de maior ocorrência (41 por cento), seguida de grau leve a moderada bilateral (20 por cento), com p<0,05 entre os três grupos. A curva timpanométrica mais frequente foi a do tipo B bilateral (39 por cento) com p<0,05 entre os três grupos. CONCLUSÃO: a maioria dos indivíduos apresentou algum tipo de queixa na entrevista audiológica e alterações na audiometria tonal limiar e imitanciometria. A maioria dessas alterações foi compatível com problemas de orelha média, com perda auditiva do tipo condutiva, de grau leve e bilateral, independentemente da indicação cirúrgica.

PURPOSE: to describe the auditory characteristics of subjects with operated cleft lip-palate (CLP) referred to otologic surgery and compare groups regarding the type and degree of hearing loss and tympanometric curve. METHODS: analysis of 150 records, of both genders, about 4-year old, with CLP and referred to otologic surgery, were divided in 3 groups (1- Ventilation tube (VT), 2- Timpanoplasty 3- Timpanomastoidectomy). Aspects were analyzed according to an auditory interview, pure-tone test and immitance measures. RESULTS: as for the surgical reference, VT showed higher prevalence of bilateral surgery (86 percent), which has not occurred with the other groups. In auditory interview 83 percent of the subjects had complaints on hearing, especially hearing loss - 64 percent (p<0.05 among groups 1 and 2, 1 and 3). The most recurrent hearing loss type was bilateral conductive (56 percent) followed by unilateral (35 percent) (p<0.05 among groups 1 and 2; 1 and 3), 41 percent had middle unilateral hearing loss and 20 percent had moderate bilateral loss, (p<0.05 among the 3 groups). Bilateral type B was the most frequent regarding the tympanometric curve (39 percent) -p<0.05 among the three groups. CONCLUSION: most of the subjects showed some kind of alteration on the auditory interview, in pure tone test and immitance measures. Many of these alterations were compatible with the middle ear pathology, with middle bilateral conductive hearing loss, regardless of the surgical reference.

Otologic and audiologic outcomes with the Furlow and von Langenbeck with intravelar veloplasty palatoplasties in unilateral cleft lip and palate.

OBJECTIVE: Cleft palate increases the risk of chronic middle ear disease and hearing loss. The goal of this report was to determine which of two palate surgeries and which timing of palate surgery were associated with better otologic and audiologic outcomes in children with unilateral cleft lip and palate at 5 to 6 years of age. DESIGN: Subjects were randomly assigned to the von Langenbeck with intravelar veloplasty or Furlow palate repair, to palate surgery at 9 to 12 months or 15 to 18 months of age, and to the Spina or Millard lip repair. SETTING: Centralized, tertiary care craniofacial treatment center. PATIENTS: A total of 673 infants with unilateral cleft lip and palate. INTERVENTIONS: Palate and lip were repaired using established techniques. Serial otoscopic and audiometric evaluations were performed. MAIN OUTCOME MEASURES: Hearing and otoscopic findings at 5 to 6 years old. RESULTS: There were 370 children available for analysis. Hearing and need for tympanostomy tube placement did not differ by palatoplasty, age at palatoplasty, cheiloplasty, or surgeon. Risk of developing cholesteatoma or perforation was higher with Millard cheiloplasty (odds ratio  =  5.1, 95% confidence interval  =  1.44 to 18.11, p  =  .012). Type and age at palatoplasty were not significantly associated with either the rate of developing these sequelae or the rate of achieving bilaterally normal hearing and ear examinations. CONCLUSIONS: Type of palatoplasty did not influence otologic and audiologic outcomes in 5- to 6-year-olds with unilateral cleft lip and palate. The potential influence of lip repair on otologic outcomes warrants further investigation.

Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP.

The goal of this prospective randomized clinical trial was to compare 2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae. The 2 cohorts are randomized to undergo either a conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure. A prospective 2 × 2 × 2 factorial clinical trial was used in which each subject was randomly assigned to 1 of 8 different groups: 1 of 2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow), and 1 of 2 different ages at time of palatal surgery (9-12 months vs. 15-18 months). All surgeries were performed by the same 4 surgeons. A cul-de-sac test of hypernasality and a mirror test of nasal air emission were selected as primary outcome measures for velopharyngeal function. Both a surgeon and speech pathologist examined patients for the presence of palatal fistulae. In this study, the Furlow double-opposing Z-palatoplasty resulted in significantly better velopharyngeal function for speech than the von Langenbeck procedure as determined by the perceptual cul-de-sac test of hypernasality. Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck. Fistulas were more likely to occur in patients with wider clefts and when relaxing incisions were not used.

Comparação dos resultados da fala após as cirurgias de retalho faríngeo e veloplastia intravelar para correção da disfunção velofaríngea / Comparison of speech results following pharyngeal flap and intravelar veloplasty for correction of velopharyngeal dysfunction

OBJETIVO: Comparar a fala e o funcionamento velofaríngeo após as técnicas de retalho faríngeo e veloplastia intravelar para a correção da disfunção velofaríngea residual. MÉTODOS: Foi realizado um estudo retrospectivo com análise de 148 casos com fissura labiopalatina operada e submetidos à correção cirúrgica da disfunção velofaríngea, sendo 77 com retalho faríngeo (média de idade: 20,4 anos) e 71 com veloplastia intravelar (média de idade: 16,2 anos). Foram avaliadas a ressonância da fala, a presença de articulações compensatórias, a emissão de ar nasal e a extensão da falha no fechamento velofaríngeo antes e após as duas técnicas. RESULTADOS: Dos 77 casos submetidos ao retalho faríngeo 64 (83 por cento) apresentaram melhora na ressonância, enquanto que dos 71 casos com veloplastia intravelar 48 (68 por cento) revelaram melhora, havendo diferença significativa entre os grupos. No grupo com retalho faríngeo, seis (8 por cento) apresentaram melhora na articulação compensatória e dois (3 por cento) no grupo veloplastia intravelar, enquanto a emissão de ar nasal melhorou em 17 (22 por cento) casos com retalho faríngeo e em 18 (26 por cento) com veloplastia intravelar. Não houve diferença entre os grupos quanto à articulação compensatória e emissão de ar nasal. A falha no fechamento velofaríngeo reduziu em 75 (96 por cento) casos com retalho faríngeo e 46 (66 por cento) com a veloplastia intravelar, havendo diferença entre os grupos. CONCLUSÃO: A técnica de retalho faríngeo mostrou-se mais efetiva na melhora da ressonância e no fechamento velofaríngeo quando comparada à veloplastia intravelar.

PURPOSE: To compare speech and velopharyngeal function after pharyngeal flap and intravelar veloplasty techniques for the correction of residual velopharyngeal dysfunction. METHODS: It was carried out a retrospective study analyzing 148 cases of cleft lip and palate operated and submitted to velopharyngeal dysfunction surgical correction, 77 with pharyngeal flap (mean age: 20.4 years) and 71 with intravelar veloplasty (mean age: 16.2 years). Speech resonance, presence of compensatory articulations, nasal air emission, and velopharyngeal gap size were assessed before and after the use of both techniques. RESULTS: Sixty four (83 percent) of the 77 cases submitted to pharyngeal flap presented resonance improvement, while 48 (68 percent) of the 71 cases with intravelar veloplasty improved, with significant difference between the groups. Six (8 percent) subjects with pharyngeal flap, and two (3 percent) with intravelar veloplasty showed improvement in compensatory articulations, while nasal air emission improved in 17 (22 percent) cases with pharyngeal flap, and 18 (26 percent) with intravelar veloplasty. No significant differences were found between the groups regarding compensatory articulations and nasal air emission. The velopharyngeal gap size reduced in 75 (96 percent) cases with pharyngeal flap, and 46 (66 percent) with intravelar veloplasty, with a significant difference between the groups. CONCLUSION: The pharyngeal flap technique was more effective in improving resonance and velopharyngeal closure, when compared to intravelar veloplasty.

Caracterização da fala de indivíduos submetidos à palatoplastia primária / Characterization of the speech of individuals submitted to primary palatoplasty

OBJETIVOS: Descrever as características de fala de indivíduos submetidos à palatoplastia primária; relacioná-las com tipo de fissura, técnica cirúrgica e idade na ocasião da cirurgia; e descrever as condutas fonoaudiológicas após a cirurgia. MÉTODOS: Estudo retrospectivo de 167 casos, de ambos os gêneros, com fissura labiopalatina, submetidos à palatoplastia primária. Foram coletadas informações relativas ao tipo de fissura, idade na palatoplastia, técnica cirúrgica, e as análises subjetivas sobre as características da fala, realizadas por fonoaudiólogas. RESULTADOS: Na avaliação perceptiva da fala após a cirurgia, encontrou-se inteligibilidade de fala alterada (46 por cento), ressonância hipernasal (33 por cento), articulações compensatórias (26 por cento), emissão de ar nasal (14 por cento), mímica facial (11 por cento) e fraca pressão aérea intra-oral (8 por cento). Na associação entre a ressonância e as articulações compensatórias com tipo de fissura, técnica cirúrgica e faixa etária, não houve diferença significativa. A conduta mais frequentemente tomada foi a de terapia fonoaudiológica (38 por cento), para correção das articulações compensatórias e/ou outras alterações. CONCLUSÃO: A maioria dos indivíduos apresentou ressonância equilibrada ou hipernasalidade aceitável e ausência de articulações compensatória, independente do tipo de fissura, da técnica cirúrgica e da faixa etária, embora não tenha ocorrido diferença significativa. Dentre as condutas adotadas após a primeira avaliação pós-palatoplastia primária, a terapia fonoaudiológica foi a mais frequente.

PURPOSE: To describe the characteristics of the speech of subjects submitted to primary palatoplasty; to related them to the type of cleft, the surgical technique and the age at the time of surgery; and to describe the Speech-Language Pathology procedures following the surgery. METHODS: A retrospective study of 167 cleft lip and palate cases, from both genders, submitted to primary palatoplasty. Information regarding the type of cleft, age at the time of surgery, and surgical technique were gathered, and subjective analyses of the auditory-perceptive characteristics of the speech were carried out by experienced Speech-Language Pathologists. RESULTS: The auditory-perceptive evaluation that followed surgery showed altered speech intelligibility (46 percent), hypernasal resonance (33 percent), compensatory articulations (26 percent), nasal air emission (14 percent), grimace (11 percent), and weak intra-oral pressure (8 percent). There was no significant difference in the association between resonance and compensatory articulations with type of cleft, surgical technique and age range. Speech therapy was the most frequent conduct taken for the correction of compensatory articulations and/or other alterations (38 percent). CONCLUSION: Most subjects presented balanced resonance or acceptable hypernasality and absence of compensatory articulation, regardless the type of cleft, surgical technique and age range, although no significant differences were found. Among the conducts adopted after the first evaluation following primary palatoplasty, speech therapy was the most frequent.

Longitudinal study of growth of children with unilateral cleft-lip palate from birth to two years of age.

OBJECTIVE: To study the growth of children with complete unilateral cleft lip and palate (UCLP) from birth to 2 years of age and to construct specific UCLP growth curves. DESIGN: Physical growth was a secondary outcome measure of a National Institutes of Health-sponsored longitudinal, prospective clinical trial involving the University of Florida (United States) and the University of São Paulo (Brazil). PATIENTS: Six hundred twenty-seven children with UCLP, nonsyndromic, both genders. METHODS: Length, weight, and head circumference were prospectively measured for a group of children enrolled in a clinical trial. Median growth curves for the three parameters (length, weight, head circumference) were performed and compared with the median for the National Center for Health Statistics (NCHS) curves. The median values for length, weight, and head circumference at birth and 6, 12, 18, and 24 months of age were plotted against NCHS median values and statistically compared at birth and 24 months. SETTING: Hospital de Reabilitação de Anomalias Craniofaciais, Universidade de São Paulo, Bauru, Brazil (HRAC-USP). RESULTS: At birth, children of both genders with UCLP presented with smaller body dimensions in relation to NCHS median values, but the results suggest a catch-up growth for length, weight, and head circumference for girls and for weight (to some degree) and head circumference for boys. CONCLUSIONS: Weight was the most compromised parameter for both genders, followed by length and then head circumference. There was no evidence of short stature. This study established growth curves for children with UCLP.

Ocorrência de hipernasalidade após adenoidectomia / Occurrence of hypernasality after adenoidectomy

Em pacientes com fissura palatina a tonsila faríngea pode participar no mecanismo de fechamento velofaríngeo, por isso a indicação da adenoidectomia deve ser criteriosa. O objetivo deste estudo foi analisar a ocorrência de hipernasalidade após a adenoidectomia em pacientes com fissura palatina (FP) do Hospital de Reabilitação de Anomalias Craniofaciais, USP, Bauru. Foram analisados 95 prontuários de pacientes com FP operada, ambos os gêneros, faixa etária acima de 4 anos, sem outros comprometimentos além da fissura. Estes realizaram avaliação da fala antes e após a cirurgia, sendo analisado os dados de ressonância da fala, por meio da análise perceptiva, teste de emissão nasal e teste de hipernasalidade, classificando-se desde a ausência de hipernasalidade até a presença mais grave da mesma.

In patients with cleft palate, the adenoid may participate in the mechanism of velopharyngeal closure, thus the indication of adenoidectomy should be careful. This study analyzed the occurrence of hypernasality after adenoidectomy in patients with cleft palate at the Hospital for Rehabilitation of Craniofacial Anomalies, USP, Bauru. The study was conducted on 95 records of patients with operated cleft palate, of both genders, aged more than 4 years, without other disturbances besides the cleft. These patients were submitted to speech evaluation before and after surgery, and the speech resonance data were assessed by perceptual analysis, nasal emission test and hypernasality test, receiving scores from the absence of hypernasality to presence of severe hypernasality.

Ocorrência de otite média na fissura de palato submucosa: dados preliminares / Occurrence of otitis media in submucous cleft palate: preliminary data

Ocorrência de otite média na fissura de palato submucosa: dados preliminares. Objetivo: Levantamento da ocorrência de otites médias, características das perdas auditivas e fatores predisponentes para otite média na fissura de palato submucosa. Método: quarenta e nove pacientes, avaliados por meio de questionário, exame otorrino-laringológico, avaliação audiológica e deglutograma. Resultado: Encontrou-se grande ocorrência de alterações da orelha média e correlação com alguns fatores predisponentes para otite média. Conclusão: Os autores assinalam a importância da prevenção de alterações da orelha média na fissura de palato submucosa e da investigação de fatores predisponentes.

Ocurrence of otitis media in submucous cleft palate: preliminary reports. Aim: A survey of otitis media ocurrence, characteristics of the hearing loss and predisponent factors for otitis media in submucous cleft palate. Method: 49 pacients were evaluated with a questionary, ENT and audiologic examinations and swallowing evaluation. Results: Great ocurrence of otitis media was found as well a significant correlation with some predisponent factors. Conclusion: The authors emphasized the importance of prevention of otitis media in submucous cleft palate and the investigation of predisponent factors for otitis media.