A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management
Creators: name: Semb, Gunvor
name: Enemark, Hans
name: Friede, Hans
name: Paulin, Gunnar
name: Lilja, Jan
name: Rautio, Jorma
name: Andersen, Mikael
name: Åbyholm, Frank
name: Lohmander, Anette
name: Shaw, William
name: Mølsted, Kirsten
name: Heliövaara, Arja
name: Bolund, Stig
name: Hukki, Jyri
name: Vindenes, Hallvard
name: Davenport, Peter
name: Arctander, Kjartan
name: Larson, Ola
name: Berggren, Anders
name: Whitby, David
name: Leonard, Alan
name: Neovius, Erik
name: Elander, Anna
name: Willadsen, Elisabeth
name: R. Patricia Bannister
name: Bradbury, Eileen
name: Henningsson, Gunilla
name: Persson, Christina
name: Eyres, Philip
name: Emborg, Berit
name: Kisling-Møller, Mia
name: Küseler, Annelise
name: Black, Birthe Granhof
name: Schöps, Antje
name: Bau, Anja
name: Boers, Maria
name: Andersen, Helene Søgaard
name: Jeppesen, Karin
name: Marxen, Dorte
name: Paaso, Marjukka
name: Hölttä, Elina
name: Alaluusua, Suvi
name: Turunen, Leena
name: Humerinta, Kirsti
name: Elfving-Little, Ulla
name: Tørdal, Inger Beate
name: Kjøll, Lillian
name: Aukner, Ragnhild
name: Øydis Hide
name: Feragen, Kristin Billaud
name: Rønning, Elisabeth
name: Skaare, Pål
name: Brinck, Eli
name: Ann-Magritt Semmingsen
name: Lindberg, Nina
name: Bowden, Melanie
name: Davies, Julie
name: Mooney, Jeanette
name: Bellardie, Haydn
name: Schofield, Nina
name: Nyberg, Jill
name: Lundberg, Maria
name: Karsten, Agneta Linder-Aronson
name: Larson, Margareta
name: Holmefjord, Anders
name: Reisæter, Sigvor
name: Nina-Helen Pedersen
name: Rasmussen, Therese
name: Tindlund, Rolf
name: Sæle, Paul
name: Blomhoff, Reidunn
name: Jacobsen, Gry
name: Havstam, Christina
name: Rizell, Sara
name: Enocson, Lars
name: Hagberg, Catharina
name: Midia Najar Chalien
name: Paganini, Anna
name: Lundeborg, Inger
name: Marcusson, Agneta
name: Anna-Britta Mjönes
name: Gustavsson, Annica
name: Hayden, Christine
name: McAleer, Eilish
name: Slevan, Emma
name: Gregg, Terry
name: Worthington, Helen
Publisher: name: Taylor & Francis
Year: 2017
Subjects: Medicine
Pharmacology
Science Policy

description: <b>Background and aims:</b> 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. <b>Method:</b> 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. <b>Results:</b> Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years. <b>Conclusion:</b> 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. <b>Trial registration:</b> ISRCTN29932826.