Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management
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Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management. / Semb, Gunvor; Enemark, Hans; Paulin, Gunnar; Rautio, Jorma; Andersen, Mikael; Åbyholm, Frank; Lohmander, Anette; Worthington, Helen; Shaw, William; Mølsted, Kirsten ; Heliövaara, Arja; Bolund, Stig ; Hukki, Jyri; Vindenes, Halvard; Davenport, Peter ; Arctander, Kjartan; Larson, Ola; Berggren, Anders; Whitby, David; Leonard, Alan; Neovius, Erik; Elander, Anna; Willadsen, Elisabeth; Bannister, Trisha; Bradbury, Eileen ; Henningsson, Gunilla; Persson , Christina; Eyres, Philip ; Emborg, Berit; Kisling-Møller, Mia; Küseler, Annelise; Granhof Black, Birthe; Schöps, Antje; Boers, Maria; Søgaard Andersen, Helene; 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; Billaud Feragen, Kristin; 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 ; Linder-Aronson Karsten, Agneta; 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.
In: Journal of Plastic Surgery and Hand Surgery, Vol. 51, No. 1, 20.02.2017, p. 2-13.Research output: Contribution to journal › Journal article › peer-review
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TY - JOUR
T1 - Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management
AU - Semb, Gunvor
AU - Enemark, Hans
AU - Paulin, Gunnar
AU - Rautio, Jorma
AU - Andersen, Mikael
AU - Åbyholm, Frank
AU - Lohmander, Anette
AU - Worthington, Helen
AU - Shaw, William
AU - Mølsted, Kirsten
AU - Heliövaara, Arja
AU - Bolund, Stig
AU - Hukki, Jyri
AU - Vindenes, Halvard
AU - Davenport, Peter
AU - Arctander, Kjartan
AU - Larson, Ola
AU - Berggren, Anders
AU - Whitby, David
AU - Leonard, Alan
AU - Neovius, Erik
AU - Elander, Anna
AU - Willadsen, Elisabeth
AU - Bannister, Trisha
AU - Bradbury, Eileen
AU - Henningsson, Gunilla
AU - Persson , Christina
AU - Eyres, Philip
AU - Emborg, Berit
AU - Kisling-Møller, Mia
AU - Küseler, Annelise
AU - Granhof Black, Birthe
AU - Schöps, Antje
AU - Boers, Maria
AU - Søgaard Andersen, Helene
AU - Jeppesen, Karin
AU - Marxen, Dorte
AU - Paaso, Marjukka
AU - Hölttä, Elina
AU - Alaluusua, Suvi
AU - Turunen, Leena
AU - Humerinta, Kirsti
AU - Elfving-Little, Ulla
AU - Tørdal, Inger-Beate
AU - Kjøll, Lillian
AU - Aukner, Ragnhild
AU - Hide, Øydis
AU - Billaud Feragen, Kristin
AU - Rønning, Elisabeth
AU - Skaare, Pål
AU - Brinck, Eli
AU - Semmingsen, Ann Magritt
AU - Lindberg, Nina
AU - Bowden, Melanie
AU - Davies, Julie
AU - Mooney, Jeanette
AU - Bellardie, Haydn
AU - Schofield, Nina
AU - Nyberg, Jill
AU - Lundberg, Maria
AU - Linder-Aronson Karsten, Agneta
AU - Larson, Margareta
AU - Holmefjord, Anders
AU - Reisæter, Sigvor
AU - Pedersen, Nina Helen
AU - Rasmussen, Therese
AU - Tindlund, Rolf
AU - Sæle, Paul
AU - Blomhoff, Reidunn
AU - Jacobsen, Gry
AU - Havstam, Christina
AU - Rizell, Sara
AU - Enocson, Lars
AU - Hagberg, Catharina
AU - Chalien, Midia Najar
AU - Paganini, Anna
AU - Lundeborg, Inger
AU - Marcusson, Agneta
AU - Mjönes, Anna-Britta
AU - Gustavsson, Annica
AU - Hayden, Christine
AU - McAleer, Eilish
AU - Slevan, Emma
AU - Gregg, Terry
PY - 2017/2/20
Y1 - 2017/2/20
N2 - Background and aims: Longstanding uncertainty surrounds the selection of surgical protocols for theclosure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. Thispaper is an introduction to three randomised trials of primary surgery for children born with completeunilateral 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 engagementand commitment required to complete the project.Method: Ten established national or regional cleft centres participated. Lip and soft palate closure at3–4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3–4months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palateclosure at 3–4 months and soft palate closure at 12 months. The primary outcomes were speech anddentofacial 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 retentionat 5 years.Conclusion: The series of reports that follow this introductory paper include comparisons at age 5 ofsurgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parentalsatisfaction. The outcomes recorded and the numbers analysed for each outcome and time pointare described in the series.Trial registration: ISRCTN29932826.
AB - Background and aims: Longstanding uncertainty surrounds the selection of surgical protocols for theclosure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. Thispaper is an introduction to three randomised trials of primary surgery for children born with completeunilateral 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 engagementand commitment required to complete the project.Method: Ten established national or regional cleft centres participated. Lip and soft palate closure at3–4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3–4months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palateclosure at 3–4 months and soft palate closure at 12 months. The primary outcomes were speech anddentofacial 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 retentionat 5 years.Conclusion: The series of reports that follow this introductory paper include comparisons at age 5 ofsurgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parentalsatisfaction. The outcomes recorded and the numbers analysed for each outcome and time pointare described in the series.Trial registration: ISRCTN29932826.
M3 - Journal article
VL - 51
SP - 2
EP - 13
JO - Journal of Plastic Surgery and Hand Surgery
JF - Journal of Plastic Surgery and Hand Surgery
SN - 2000-656X
IS - 1
ER -
ID: 168259786