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Review
. 2017 Feb;51(1):2-13.
doi: 10.1080/2000656X.2016.1263202.

A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management

Gunvor Semb  1   2   3 , Hans Enemark  4 , Hans Friede  5 , Gunnar Paulin  6 , Jan Lilja  7 , Jorma Rautio  8 , Mikael Andersen  9 , Frank Åbyholm  2 , Anette Lohmander  10 , William Shaw  1 , Kirsten Mølsted  9 , Arja Heliövaara  8 , Stig Bolund  9 , Jyri Hukki  8 , Hallvard Vindenes  11 , Peter Davenport  12 , Kjartan Arctander  2 , Ola Larson  13 , Anders Berggren  14 , David Whitby  12 , Alan Leonard  15 , Erik Neovius  13 , Anna Elander  7 , Elisabeth Willadsen  16 , R Patricia Bannister  12 , Eileen Bradbury  17 , Gunilla Henningsson  13 , Christina Persson  18   19 , Philip Eyres  1 , Berit Emborg  4 , Mia Kisling-Møller  1 , Annelise Küseler  1 , Birthe Granhof Black  1 , Antje Schöps  9 , Anja Bau  9 , Maria Boers  9 , Helene Søgaard Andersen  9 , Karin Jeppesen  9 , Dorte Marxen  9 , Marjukka Paaso  8 , Elina Hölttä  8 , Suvi Alaluusua  8 , Leena Turunen  8 , Kirsti Humerinta  8 , Ulla Elfving-Little  8 , Inger Beate Tørdal  3 , Lillian Kjøll  3 , Ragnhild Aukner  3 , Øydis Hide  3 , Kristin Billaud Feragen  3 , Elisabeth Rønning  2 , Pål Skaare  2 , Eli Brinck  2 , Ann-Magritt Semmingsen  2 , Nina Lindberg  2 , Melanie Bowden  12 , Julie Davies  12 , Jeanette Mooney  12 , Haydn Bellardie  12 , Nina Schofield  12 , Jill Nyberg  13 , Maria Lundberg  13 , Agneta Linder-Aronson Karsten  20 , Margareta Larson  21 , Anders Holmefjord  22 , Sigvor Reisæter  22 , Nina-Helen Pedersen  22 , Therese Rasmussen  22 , Rolf Tindlund  23 , Paul Sæle  24 , Reidunn Blomhoff  11 , Gry Jacobsen  11 , Christina Havstam  19 , Sara Rizell  5 , Lars Enocson  5 , Catharina Hagberg  5 , Midia Najar Chalien  5 , Anna Paganini  7 , Inger Lundeborg  25 , Agneta Marcusson  6 , Anna-Britta Mjönes  14 , Annica Gustavsson  6 , Christine Hayden  15 , Eilish McAleer  15 , Emma Slevan  15 , Terry Gregg  15 , Helen Worthington  1
Affiliations
Review

A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management

Gunvor Semb et al. J Plast Surg Hand Surg. 2017 Feb.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] J Plast Surg Hand Surg. 2017 Apr;51(2):158. doi: 10.1080/2000656X.2017.1302182. J Plast Surg Hand Surg. 2017. PMID: 28332929 No abstract available.

Abstract

Background and aims: Longstanding uncertainty surrounds the selection of surgical protocols for the 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.

Keywords: Scandcleft Project; multicentre study; randomised controlled trials; surgery for unilateral complete cleft lip and palate.

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