title: A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN29932826.
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.|b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.|c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Gunvor
authors.initials: G
authors.lastname: Semb
authors.affiliation: d Cleft Palate Center , Aarhus , Denmark.
authors.forename: Hans
authors.initials: H
authors.lastname: Enemark
authors.affiliation: e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Hans
authors.initials: H
authors.lastname: Friede
authors.affiliation: f Department of Dentofacial Orthopedics , University Hospital , Linköping , Sweden.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Paulin
authors.affiliation: g Department of Plastic Surgery , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Lilja
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Jorma
authors.initials: J
authors.lastname: Rautio
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Mikael
authors.initials: M
authors.lastname: Andersen
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Frank
authors.initials: F
authors.lastname: Åbyholm
authors.affiliation: j Division of Speech and Language Pathology , Karolinska Institute, and Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Anette
authors.initials: A
authors.lastname: Lohmander
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.
authors.forename: William
authors.initials: W
authors.lastname: Shaw
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Mølsted
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Arja
authors.initials: A
authors.lastname: Heliövaara
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Stig
authors.initials: S
authors.lastname: Bolund
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Jyri
authors.initials: J
authors.lastname: Hukki
authors.affiliation: k Centre for Cleft Lip and Palate, Bergen University Hospital Haukeland , Bergen , Norway.
authors.forename: Hallvard
authors.initials: H
authors.lastname: Vindenes
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Davenport
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Kjartan
authors.initials: K
authors.lastname: Arctander
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Ola
authors.initials: O
authors.lastname: Larson
authors.affiliation: n Department of Plastic Surgery , University Hospital , Linköping , Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Berggren
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: David
authors.initials: D
authors.lastname: Whitby
authors.affiliation: o The Royal Hospital for Sick Children , Belfast , N. Ireland.
authors.forename: Alan
authors.initials: A
authors.lastname: Leonard
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Neovius
authors.affiliation: g Department of Plastic Surgery , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Elander
authors.affiliation: p Department of Nordic Studies and Linguistics , University of Copenhagen , Denmark.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Willadsen
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: R Patricia
authors.initials: RP
authors.lastname: Bannister
authors.affiliation: q Private Practitioner , Manchester , UK.
authors.forename: Eileen
authors.initials: E
authors.lastname: Bradbury
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Gunilla
authors.initials: G
authors.lastname: Henningsson
authors.affiliation: r Institute of Neuroscience and Physiology, Speech and Language Pathology Unit , Sahlgrenska Academy, University of Gothenburg , Sweden.|s Division for Speech and Language Pathology , Sahlgrenska University Hospital , Gothenburg , Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Persson
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Eyres
authors.affiliation: d Cleft Palate Center , Aarhus , Denmark.
authors.forename: Berit
authors.initials: B
authors.lastname: Emborg
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.
authors.forename: Mia
authors.initials: M
authors.lastname: Kisling-Møller
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.
authors.forename: Annelise
authors.initials: A
authors.lastname: Küseler
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.
authors.forename: Birthe
authors.initials: B
authors.lastname: Granhof Black
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Antje
authors.initials: A
authors.lastname: Schöps
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Anja
authors.initials: A
authors.lastname: Bau
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Maria
authors.initials: M
authors.lastname: Boers
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Helene Søgaard
authors.initials: HS
authors.lastname: Andersen
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Karin
authors.initials: K
authors.lastname: Jeppesen
authors.affiliation: i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.
authors.forename: Dorte
authors.initials: D
authors.lastname: Marxen
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Marjukka
authors.initials: M
authors.lastname: Paaso
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Elina
authors.initials: E
authors.lastname: Hölttä
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Suvi
authors.initials: S
authors.lastname: Alaluusua
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Leena
authors.initials: L
authors.lastname: Turunen
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Kirsti
authors.initials: K
authors.lastname: Humerinta
authors.affiliation: h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Ulla
authors.initials: U
authors.lastname: Elfving-Little
authors.affiliation: c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Inger Beate
authors.initials: IB
authors.lastname: Tørdal
authors.affiliation: c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Lillian
authors.initials: L
authors.lastname: Kjøll
authors.affiliation: c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Ragnhild
authors.initials: R
authors.lastname: Aukner
authors.affiliation: c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Øydis
authors.initials: Ø
authors.lastname: Hide
authors.affiliation: c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Kristin Billaud
authors.initials: KB
authors.lastname: Feragen
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Rønning
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Pål
authors.initials: P
authors.lastname: Skaare
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Eli
authors.initials: E
authors.lastname: Brinck
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Ann-Magritt
authors.initials: AM
authors.lastname: Semmingsen
authors.affiliation: b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Nina
authors.initials: N
authors.lastname: Lindberg
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Bowden
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Davies
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Mooney
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Haydn
authors.initials: H
authors.lastname: Bellardie
authors.affiliation: l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Nina
authors.initials: N
authors.lastname: Schofield
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Jill
authors.initials: J
authors.lastname: Nyberg
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Lundberg
authors.affiliation: t Stockholm Craniofacial Team, Department of Dental Medicine , Karolinska Institute , Stockholm , Sweden.
authors.forename: Agneta Linder-Aronson
authors.initials: AL
authors.lastname: Karsten
authors.affiliation: u Eastman Institute, Stockholms Läns Landsting , Stockholm , Sweden.
authors.forename: Margareta
authors.initials: M
authors.lastname: Larson
authors.affiliation: v Statped vest , Bergen , Norway.
authors.forename: Anders
authors.initials: A
authors.lastname: Holmefjord
authors.affiliation: v Statped vest , Bergen , Norway.
authors.forename: Sigvor
authors.initials: S
authors.lastname: Reisæter
authors.affiliation: v Statped vest , Bergen , Norway.
authors.forename: Nina-Helen
authors.initials: NH
authors.lastname: Pedersen
authors.affiliation: v Statped vest , Bergen , Norway.
authors.forename: Therese
authors.initials: T
authors.lastname: Rasmussen
authors.affiliation: w Dental School, University of Bergen , Bergen , Norway.
authors.forename: Rolf
authors.initials: R
authors.lastname: Tindlund
authors.affiliation: x Oral Health Center of Expertise/Western Norway , Bergen , Norway.
authors.forename: Paul
authors.initials: P
authors.lastname: Sæle
authors.affiliation: k Centre for Cleft Lip and Palate, Bergen University Hospital Haukeland , Bergen , Norway.
authors.forename: Reidunn
authors.initials: R
authors.lastname: Blomhoff
authors.affiliation: k Centre for Cleft Lip and Palate, Bergen University Hospital Haukeland , Bergen , Norway.
authors.forename: Gry
authors.initials: G
authors.lastname: Jacobsen
authors.affiliation: s Division for Speech and Language Pathology , Sahlgrenska University Hospital , Gothenburg , Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Havstam
authors.affiliation: e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Sara
authors.initials: S
authors.lastname: Rizell
authors.affiliation: e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Enocson
authors.affiliation: e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Catharina
authors.initials: C
authors.lastname: Hagberg
authors.affiliation: e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Midia
authors.initials: M
authors.lastname: Najar Chalien
authors.affiliation: g Department of Plastic Surgery , Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Paganini
authors.affiliation: y Division of Speech and Language Pathology , Linköping University , Linköping , Sweden.
authors.forename: Inger
authors.initials: I
authors.lastname: Lundeborg
authors.affiliation: f Department of Dentofacial Orthopedics , University Hospital , Linköping , Sweden.
authors.forename: Agneta
authors.initials: A
authors.lastname: Marcusson
authors.affiliation: n Department of Plastic Surgery , University Hospital , Linköping , Sweden.
authors.forename: Anna-Britta
authors.initials: AB
authors.lastname: Mjönes
authors.affiliation: f Department of Dentofacial Orthopedics , University Hospital , Linköping , Sweden.
authors.forename: Annica
authors.initials: A
authors.lastname: Gustavsson
authors.affiliation: o The Royal Hospital for Sick Children , Belfast , N. Ireland.
authors.forename: Christine
authors.initials: C
authors.lastname: Hayden
authors.affiliation: o The Royal Hospital for Sick Children , Belfast , N. Ireland.
authors.forename: Eilish
authors.initials: E
authors.lastname: McAleer
authors.affiliation: o The Royal Hospital for Sick Children , Belfast , N. Ireland.
authors.forename: Emma
authors.initials: E
authors.lastname: Slevan
authors.affiliation: o The Royal Hospital for Sick Children , Belfast , N. Ireland.
authors.forename: Terry
authors.initials: T
authors.lastname: Gregg
authors.affiliation: a Division of Dentistry, University of Manchester , Manchester , UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Worthington
mesh_terms: D016009:Chi-Square Distribution; D002675:Child, Preschool; D002971:Cleft Lip / Q000175:diagnosis / Q000523:psychology / Q000601:surgery*; D002972:Cleft Palate / Q000175:diagnosis / Q000523:psychology / Q000601:surgery*; D019468:Disease Management; D004954:Esthetics; D005260:Female; D005500:Follow-Up Studies; D006285:Health Planning; D006801:Humans; D007223:Infant; D008297:Male; D015588:Observer Variation; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D019651:Plastic Surgery Procedures / Q000379:methods*; D018570:Risk Assessment; D016896:Treatment Outcome
keywords: Scandcleft Project; multicentre study; randomised controlled trials; surgery for unilateral complete cleft lip and palate