Background and aim: Facial appearance is one of the most relevant measures of success in cleft lip and palate treatment. The aim was to assess nasolabial appearance at 5 years of age in all children in the project. In this part of the project the local protocol for lip closure continued to be used because the primary lip and nose operations were not part of the randomisation. The great majority of the surgeons used Millard's technique together with McComb's technique for the nose. One center used Tennison-Randalls technique and in one center the centers own technique as well as nose plugs were used.
Methods: Three hundred and fifty-nine children participated in this part of the project. Standardised photos according to a specific protocol developed for the Scandcleft project were taken. Only the nasolabial area was shown, the surrounding facial features were masked. Three components were scored using a 5-point ordinal scale. A new developed Scandcleft Yardstick was used.
Results: The reliability of the method was tested using the weighted kappa statistics. Both the interrater and intrarater reliability scores were good to very good. There were statistically significant differences between the three trials.
Conclusion: The Millard procedure combined with McComb technique had been used in the majority of the cases in all three trials. There were statistically significant differences between the three trials concerning upper lip, nasal form, and cleft side profile.
Trial registration: ISRCTN29932826.
Keywords: 5 years; RCT studies; Scandcleft; facial esthetics; multicenter study; nasolabial appearance; unilateral cleft lip and palate.