Cleft lip and/or palate: one organization's experience with more than a quarter million surgeries during the past decade.

Background: A charitable surgical relief organization (Smile Train) enables local physicians in developing countries to provide surgical treatment of cleft lip and/or palate. The following study reviews the epidemiological data from more than 260,000 surgeries performed in India through this organization from 2000 until January 1, 2012.

Methods: Demographic and clinical patient data were collected from the participating surgeons, recorded in Excel (Microsoft, Redmond, WA), and analyzed using Software Package for the Social Sciences (IBM, Armonk, NY).

Results: The distribution of clefts treated was 20.2% of cleft lip, 13.9% of cleft palate (CP), and 65.9% of cleft lip and palate. The overall unilateral-bilateral ratio was 2.49:1 with a left-right ratio of 2.03:1. The male-female ratio was 1.58:1. Of the total patients, 2.67% had associated anomalies. The most frequently performed surgeries included primary repair of a unilateral cleft lip (41.62%), followed by primary repair of a CP (31.15%). The mean age at surgery was 7.91 years. The reported complication rate was 0.88%.

Conclusions: The data collected are from the largest reported cohort of orofacial cleft patients in India. The cleft type, sex distribution, and overall male predominance resemble previously reported distributions; however, fewer CP patients and greater cleft lip and palate patients presented than would be expected. The frequency of associated anomalies was lower than in previous reports. Although there is significant selection bias to milder cases from lower socioeconomic groups in this study, the large sample size is unique, and the data collected can provide a valuable framework to further study the epidemiology of cleft lip and/or palate in India.