Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management
Research output: Contribution to journal › Journal article › Research › peer-review
Gunvor Semb, Hans Enemark, Gunnar Paulin, Jorma Rautio, Mikael Andersen, Frank Åbyholm, Anette Lohmander, Helen Worthington, William Shaw, Kirsten Mølsted, Arja Heliövaara, Stig Bolund, Jyri Hukki, Halvard Vindenes, Peter Davenport, Kjartan Arctander, Ola Larson, Anders Berggren, David Whitby, Alan Leonard & 64 others
closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This
paper is an introduction to three randomised trials of primary surgery for children born with complete
unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format,
and describes the management structure that was developed to achieve the long-term engagement
and commitment required to complete the project.
Method: Ten established national or regional cleft centres participated. Lip and soft palate closure at
3–4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1
compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3–4
months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate
closure at 3–4 months and soft palate closure at 12 months. The primary outcomes were speech and
dentofacial development, with a series of perioperative and longer-term secondary outcomes.
Results: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention
at 5 years.
Conclusion: The series of reports that follow this introductory paper include comparisons at age 5 of
surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental
satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point
are described in the series.
Trial registration: ISRCTN29932826.
|Journal||Journal of Plastic Surgery and Hand Surgery|
|Number of pages||12|
|Publication status||Published - 20 Feb 2017|