Otologic Disease Following Palatoplasty In International Cleft Palate Cohort.

OBJECTIVE: Study the prevalence of otologic disease in a pediatric post-palatoplasty population with no prior ear tube placement in resource-deprived countries and assess patient characteristics associated with these abnormal results. DESIGN: Retrospective data review. PARTICIPANTS: Ecuadorian and Chinese children identified during humanitarian cleft lip and palate repair trips with cleft palates undergoing palatoplasty from 2007 to 2010. INTERVENTIONS: Tympanometry and otoacoustic emission (OAE) testing performed following palatoplasty. Patients' parents administered surveys regarding perceived hearing deficits. MAIN OUTCOME MEASURES: Age, gender, Veau classification, follow-up time, laterality, and country of origin were evaluated for possible association with type B tympanogram, "Refer" Otoacoustic results, and presence of hearing difficulty as identified by a parent. Significant predictors were further evaluated with multivariate analysis. RESULTS: The cohorts included 237 patients (129 Ecuadorian, 108 Chinese); mean age: 3.9 years; mean follow-up: 4.2 years. Thirty-nine percent scored type B, 38% failed OAE testing, and 8% of parents noted hearing deficits. The country of origin and a younger age were identified as predictive variables regarding type B tympanogram. Follow-up time, country of origin, and bilateral OAE "Refer" results all significantly predicted parental questionnaire results. Subsequent multivariable analysis further demonstrated effect modification between the 2 variables of age at palatoplasty and country of origin when predicting type B vs type A tympanometry. CONCLUSION: Without otologic intervention, cleft palate children in resource-deprived settings suffer type B tympanometry and failed OAE results with similar to increased incidences to other studied cleft palate populations with otologic interventions available.

Palatal fistula risk after primary palatoplasty: a retrospective comparison of humanitarian operations and tertiary hospitals.

BACKGROUND: Humanitarian surgical organisations provide cleft palate repair for patients without access to surgical care. Despite decades of experience, very little research has assessed the outcomes of these trips. This study investigates the fistula rate in patients from two cohorts in rural China and one in the USA. METHODS: This retrospective study compared the odds of fistula presentation among three cohorts whose palates were repaired between April, 2005, and November, 2009. The primary cohort included 97 Chinese patients operated on in China by surgeons from ReSurge International. A second Chinese cohort of 250 patients was operated on at Huaxi University Hospital by Chinese surgeons. The third cohort of 120 patients from the University of California San Francisco (UCSF) was included for comparison over the same time period; data was taken from medical records. Age, fistula presentation, and Veau Class were compared between the three cohorts with χ(2) tests. Logistic regression was used to analyse predictors of fistula presentation among the three cohorts. This study received institutional review board approval from the UCSF, the Harvard School of Public Health, and physicians at Huaxi University Hospital, and written consent was obtained from study participants in China. FINDINGS: The fistula risk was 35·4% in ReSurge patients, 12·8% for patients at Huaxi University Hospital, and 2·5% for patients at UCSF (p<0·001). At the time of surgery 15·5% of the ReSurge patients were younger than 2 years old, whereas 90·8% of the UCSF children and 41·6% of the Huaxi children were (p<0·001). In the ReSurge cohort, 20·6% of patients had a Veau class of I or II, wheras 40·8% and 58·9% of UCSF and Huaxi patients, respectively, were in class I or II (p<0·001). Age and Veau Class were associated with fistula formation in a univariate analysis. (Veau Class III or IV vs I or II, odds ratio [OR] 6·399 [95% CI 3·182-12·871]; age, OR 1·071 [95% CI 1·024-1·122]). A multivariate model controlling for the surgical group, age at palatoplasty, and sex showed an association between Veau Class and the odds of fistula presentation (Class III or IV vs I or II, OR 5·630 [95% CI 2·677-11·837). In this model, UCSF patients and Huaxi patients had 0·064 and 0·451 times the odds of developing a fistula, respectively, compared with ReSurge patients (p<0·001 both). INTERPRETATION: Chinese children undergoing palatoplasty on surgical missions have higher post-operative odds of palatal fistula than do children treated by local physicians. Children in low-resource settings have higher complication rates than do children in high-resource settings. Older age at palatoplasty and a Veau class III and IV are associated with post-palatoplasty fistula. Furthermore demographic, socioeconomic, and cultural differences could play a part in palatoplasty fistula outcomes between these three populations. More research is needed to determine the effects of post-operative care, the skill of the providers, and the technique used in the surgery that play a role on fistula outcomes after primary palatoplasty, particularly in low-resource environments. FUNDING: None.