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

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Harvard

Semb, G, Enemark, H, Friede, H, Paulin, G, Lilja, J, Rautio, J, Andersen, M, Åbyholm, F, Lohmander, A, Shaw, W, Pedersen, KM, Heliövaara, A, Bolund, S, Hukki, J, Vindenes, H, Davenport, P, Arctander, K, Larson, O, Berggren, AR, Whitby, D, Leonard, A, Neovius, E, Elander, A, Willadsen, E, Bannister, RP, Bradbury, E, Henningsson, G, Persson, C, Eyres, P, Emborg, B, Kisling-Møller, M, Küseler, A, Granhof Black, B, Schöps, A, Bau, A, Boers, M, Andersen, HS, Jeppesen, K, Marxen, D, Paaso, M, Hölttä, E, Alaluusua, S, Turunen, L, Humerinta, K, Elfving-Little, U, Tørdal, IB, Kjøll, L, Aukner, R, Hide, Ø, Feragen, KB, Rønning, E, Skaare, P, Brinck, E, Semmingsen, A-M, Lindberg, N, Bowden, M, Davies, J, Mooney, J, Bellardie, H, Schofield, N, Nyberg, J, Lundberg, M, Karsten, AL-A, Larson, M, Holmefjord, A, Reisæter, S, Pedersen, N-H, Rasmussen, T, Tindlund, R, Sæle, P, Blomhoff, R, Jacobsen, G, Havstam, C, Rizell, S, Enocson, L, Hagberg, C, Najar Chalien, M, Paganini, A, Lundeborg, I, Marcusson, A, Mjönes, A-B, Gustavsson, A, Hayden, C, McAleer, E, Slevan, E, Gregg, T & Worthington, HV 2017, 'A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management' Journal of Plastic Surgery and Hand Surgery, vol. 51, no. 1, pp. 2-13. https://doi.org/10.1080/2000656X.2016.1263202

APA

CBE

Semb G, Enemark H, Friede H, Paulin G, Lilja J, Rautio J, Andersen M, Åbyholm F, Lohmander A, Shaw W, Pedersen KM, Heliövaara A, Bolund S, Hukki J, Vindenes H, Davenport P, Arctander K, Larson O, Berggren AR, Whitby D, Leonard A, Neovius E, Elander A, Willadsen E, Bannister RP, Bradbury E, Henningsson G, Persson C, Eyres P, Emborg B, Kisling-Møller M, Küseler A, Granhof Black B, Schöps A, Bau A, Boers M, Andersen HS, Jeppesen K, Marxen D, Paaso M, Hölttä E, Alaluusua S, Turunen L, Humerinta K, Elfving-Little U, Tørdal IB, Kjøll L, Aukner R, Hide Ø, Feragen KB, Rønning E, Skaare P, Brinck E, Semmingsen A-M, Lindberg N, Bowden M, Davies J, Mooney J, Bellardie H, Schofield N, Nyberg J, Lundberg M, Karsten AL-A, Larson M, Holmefjord A, Reisæter S, Pedersen N-H, Rasmussen T, Tindlund R, Sæle P, Blomhoff R, Jacobsen G, Havstam C, Rizell S, Enocson L, Hagberg C, Najar Chalien M, Paganini A, Lundeborg I, Marcusson A, Mjönes A-B, Gustavsson A, Hayden C, McAleer E, Slevan E, Gregg T, Worthington HV. 2017. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management. Journal of Plastic Surgery and Hand Surgery. 51(1):2-13. https://doi.org/10.1080/2000656X.2016.1263202

MLA

Vancouver

Author

Semb, Gunvor ; Enemark, Hans ; Friede, Hans ; Paulin, Gunnar ; Lilja, Jan ; Rautio, Jorma ; Andersen, Mikael ; Åbyholm, Frank ; Lohmander, Anette ; Shaw, William ; Pedersen, Kirsten Mølsted ; Heliövaara, Arja ; Bolund, Stig ; Hukki, Jyri ; Vindenes, Hallvard ; Davenport, Peter ; Arctander, Kjartan ; Larson, Ola ; Berggren, Anders R ; 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 ; Granhof Black, Birthe ; 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 ; Najar Chalien, Midia ; Paganini, Anna ; Lundeborg, Inger ; Marcusson, Agneta ; Mjönes, Anna-Britta ; Gustavsson, Annica ; Hayden, Christine ; McAleer, Eilish ; Slevan, Emma ; Gregg, Terry ; Worthington, Helen V. / A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate : 1. Planning and management. In: Journal of Plastic Surgery and Hand Surgery. 2017 ; Vol. 51, No. 1. pp. 2-13.

Bibtex

@article{4f98c119c856435fbb44c66cbff84155,
title = "A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management",
abstract = "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.",
keywords = "Journal Article",
author = "Gunvor Semb and Hans Enemark and Hans Friede and Gunnar Paulin and Jan Lilja and Jorma Rautio and Mikael Andersen and Frank {\AA}byholm and Anette Lohmander and William Shaw and Pedersen, {Kirsten M{\o}lsted} and Arja Heli{\"o}vaara and Stig Bolund and Jyri Hukki and Hallvard Vindenes and Peter Davenport and Kjartan Arctander and Ola Larson and Berggren, {Anders R} and David Whitby and Alan Leonard and Erik Neovius and Anna Elander and Elisabeth Willadsen and Bannister, {R Patricia} and Eileen Bradbury and Gunilla Henningsson and Christina Persson and Philip Eyres and Berit Emborg and Mia Kisling-M{\o}ller and Annelise K{\"u}seler and {Granhof Black}, Birthe and Antje Sch{\"o}ps and Anja Bau and Maria Boers and Andersen, {Helene S{\o}gaard} and Karin Jeppesen and Dorte Marxen and Marjukka Paaso and Elina H{\"o}ltt{\"a} and Suvi Alaluusua and Leena Turunen and Kirsti Humerinta and Ulla Elfving-Little and T{\o}rdal, {Inger Beate} and Lillian Kj{\o}ll and Ragnhild Aukner and {\O}ydis Hide and Feragen, {Kristin Billaud} and Elisabeth R{\o}nning and P{\aa}l Skaare and Eli Brinck and Ann-Magritt Semmingsen and Nina Lindberg and Melanie Bowden and Julie Davies and Jeanette Mooney and Haydn Bellardie and Nina Schofield and Jill Nyberg and Maria Lundberg and Karsten, {Agneta Linder-Aronson} and Margareta Larson and Anders Holmefjord and Sigvor Reis{\ae}ter and Nina-Helen Pedersen and Therese Rasmussen and Rolf Tindlund and Paul S{\ae}le and Reidunn Blomhoff and Gry Jacobsen and Christina Havstam and Sara Rizell and Lars Enocson and Catharina Hagberg and {Najar Chalien}, Midia and Anna Paganini and Inger Lundeborg and Agneta Marcusson and Anna-Britta Mj{\"o}nes and Annica Gustavsson and Christine Hayden and Eilish McAleer and Emma Slevan and Terry Gregg and Worthington, {Helen V}",
year = "2017",
month = "2",
doi = "10.1080/2000656X.2016.1263202",
language = "English",
volume = "51",
pages = "2--13",
journal = "Journal of Plastic Surgery and Hand Surgery",
issn = "2000-656X",
publisher = "Informa Healthcare",
number = "1",

}

RIS

TY - JOUR

T1 - A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

T2 - 1. Planning and management

AU - Semb, Gunvor

AU - Enemark, Hans

AU - Friede, Hans

AU - Paulin, Gunnar

AU - Lilja, Jan

AU - Rautio, Jorma

AU - Andersen, Mikael

AU - Åbyholm, Frank

AU - Lohmander, Anette

AU - Shaw, William

AU - Pedersen, Kirsten Mølsted

AU - Heliövaara, Arja

AU - Bolund, Stig

AU - Hukki, Jyri

AU - Vindenes, Hallvard

AU - Davenport, Peter

AU - Arctander, Kjartan

AU - Larson, Ola

AU - Berggren, Anders R

AU - Whitby, David

AU - Leonard, Alan

AU - Neovius, Erik

AU - Elander, Anna

AU - Willadsen, Elisabeth

AU - Bannister, R Patricia

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 - Bau, Anja

AU - Boers, Maria

AU - Andersen, Helene Søgaard

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 - Feragen, Kristin Billaud

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 - Karsten, Agneta Linder-Aronson

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 - Najar Chalien, Midia

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

AU - Worthington, Helen V

PY - 2017/2

Y1 - 2017/2

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1080/2000656X.2016.1263202

DO - 10.1080/2000656X.2016.1263202

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: 51555492