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

Journal article
Authors 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 Enochson
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
Published in Journal of plastic surgery and hand surgery
Volume 51
Issue 1
Pages 2-13
ISSN 2000-6764
Publication year 2017
Published at Institute of Odontology
Institute of Neuroscience and Physiology, Department of Health and Rehabilitation
Institute of Biomedicine, Department of Clinical Chemistry and Transfusion Medicine
Institute of Clinical Sciences, Section for Surgery and Gastrosurgical Research and Education, Department of Plastic Surgery
Pages 2-13
Language en
Links dx.doi.org/10.1080/2000656X.2016.12...
www.ncbi.nlm.nih.gov/entrez/query.f...
Subject categories Logopedics and phoniatrics

Abstract

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.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.Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years.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.ISRCTN29932826.

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