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

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

doi:10.6084/m9.figshare.4668493.v2

iphs_a_1263202_sm4018.pdf (15.49 MB)

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

Version 2 2017-03-08, 13:39

Version 1 2017-02-20, 13:37

journal contribution

posted on 2017-03-08, 13:39 authored by Gunvor Semb, Hans Enemark, Hans Friede, Gunnar Paulin, Jan Lilja, Jorma Rautio, Mikael Andersen, Frank Åbyholm, Anette Lohmander, William Shaw, Kirsten Mølsted, Arja Heliövaara, Stig Bolund, Jyri Hukki, Hallvard Vindenes, Peter Davenport, Kjartan Arctander, Ola Larson, Anders Berggren, David Whitby, Alan Leonard, Erik Neovius, Anna Elander, Elisabeth Willadsen, R. Patricia Bannister, Eileen Bradbury, Gunilla Henningsson, Christina Persson, Philip Eyres, Berit Emborg, Mia Kisling-Møller, Annelise Küseler, Birthe Granhof Black, Antje Schöps, Anja Bau, Maria Boers, Helene Søgaard Andersen, Karin Jeppesen, Dorte Marxen, Marjukka Paaso, Elina Hölttä, Suvi Alaluusua, Leena Turunen, Kirsti Humerinta, Ulla Elfving-Little, Inger Beate Tørdal, Lillian Kjøll, Ragnhild Aukner, Øydis Hide, Kristin Billaud Feragen, Elisabeth Rønning, Pål Skaare, Eli Brinck, Ann-Magritt Semmingsen, Nina Lindberg, Melanie Bowden, Julie Davies, Jeanette Mooney, Haydn Bellardie, Nina Schofield, Jill Nyberg, Maria Lundberg, Agneta Linder-Aronson Karsten, Margareta Larson, Anders Holmefjord, Sigvor Reisæter, Nina-Helen Pedersen, Therese Rasmussen, Rolf Tindlund, Paul Sæle, Reidunn Blomhoff, Gry Jacobsen, Christina Havstam, Sara Rizell, Lars Enocson, Catharina Hagberg, Midia Najar Chalien, Anna Paganini, Inger Lundeborg, Agneta Marcusson, Anna-Britta Mjönes, Annica Gustavsson, Christine Hayden, Eilish McAleer, Emma Slevan, Terry Gregg, Helen Worthington

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.