Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 8. Assessing naso-labial appearance in 5-year-olds - a preliminary study

Abstract

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:

• RCT studies
• Scandcleft
• unilateral cleft lip and palate
• nasolabial appearance
• facial esthetics
• 5 years
• multicenter study

Acknowledgements

We thank our four surgeons, Anna Elander (Department of Plastic Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, at Sahlgrenska University Hospital, Sweden), Erik Neovius (Department of Reconstructive Plastic Surgery, Karolinska University Hospital Solna, Sweden), David Whitby (Royal Manchester Children’s Hospital, Manchester, UK), and Mikael Andersen (Department of Plastic and Reconstructive Surgery, University Hospital of Copenhagen, Denmark) for developing the Scandcleft Yardstick. We thank Associate professor Theis Lange (Section of Biostatistics Faculty of Health Sciences, University of Copenhagen, Denmark) for statistically guidance and we thank research assistant Monique Mensink Jeppesen (Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark) for performing data management, the statistical analyses, and assisting with the set-up of the article.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.