Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

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 journalJournal articleResearchpeer-review

Harvard

Semb, G, Enemark, H, Paulin, G, Rautio, J, Andersen, M, Åbyholm, F, Lohmander, A, Worthington, H, Shaw, W, Mølsted, K, Heliövaara, A, Bolund, S, Hukki, J, Vindenes, H, Davenport, P, Arctander, K, Larson, O, Berggren, A, Whitby, D, Leonard, A, Neovius, E, Elander, A, Willadsen, E, Bannister, T, Bradbury, E, Henningsson, G, Persson , C, Eyres, P, Emborg, B, Kisling-Møller, M, Küseler, A, Granhof Black, B, Schöps, A, Boers, M, Søgaard Andersen, H, Jeppesen, K, Marxen, D, Paaso, M, Hölttä, E, Alaluusua, S, Turunen, L, Humerinta, K, Elfving-Little, U, Tørdal, I-B, Kjøll, L, Aukner, R, Hide, Ø, Billaud Feragen, K, Rønning, E, Skaare, P, Brinck, E, Semmingsen, AM, Lindberg, N, Bowden, M, Davies, J, Mooney, J, Bellardie, H, Schofield, N, Nyberg, J, Lundberg, M, Linder-Aronson Karsten, A, Larson, M, Holmefjord, A, Reisæter, S, Pedersen, NH, Rasmussen, T, Tindlund, R, Sæle, P, Blomhoff, R, Jacobsen, G, Havstam, C, Rizell, S, Enocson, L, Hagberg, C, Chalien, MN, Paganini, A, Lundeborg, I, Marcusson, A, Mjönes, A-B, Gustavsson, A, Hayden, C, McAleer, E, Slevan, E & Gregg, T 2017, 'Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management', Journal of Plastic Surgery and Hand Surgery, vol. 51, no. 1, pp. 2-13.

APA

Semb, G., Enemark, H., Paulin, G., Rautio, J., Andersen, M., Åbyholm, F., ... Gregg, T. (2017). Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management. Journal of Plastic Surgery and Hand Surgery, 51(1), 2-13.

Vancouver

Semb G, Enemark H, Paulin G, Rautio J, Andersen M, Åbyholm F et al. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management. Journal of Plastic Surgery and Hand Surgery. 2017 Feb 20;51(1):2-13.

Author

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. / Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management. In: Journal of Plastic Surgery and Hand Surgery. 2017 ; Vol. 51, No. 1. pp. 2-13.

Bibtex

@article{19ae98cc4d0e4f0192f5949dca783af6,
title = "Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management",
abstract = "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.",
author = "Gunvor Semb and Hans Enemark and Gunnar Paulin and Jorma Rautio and Mikael Andersen and Frank {\AA}byholm and Anette Lohmander and Helen Worthington and William Shaw and Kirsten M{\o}lsted and Arja Heli{\"o}vaara and Stig Bolund and Jyri Hukki and Halvard Vindenes and Peter Davenport and Kjartan Arctander and Ola Larson and Anders Berggren and David Whitby and Alan Leonard and Erik Neovius and Anna Elander and Elisabeth Willadsen and Trisha Bannister 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 Maria Boers and {S{\o}gaard Andersen}, Helene 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 Inger-Beate T{\o}rdal and Lillian Kj{\o}ll and Ragnhild Aukner and {\O}ydis Hide and {Billaud Feragen}, Kristin and Elisabeth R{\o}nning and P{\aa}l Skaare and Eli Brinck and Semmingsen, {Ann Magritt} 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 {Linder-Aronson Karsten}, Agneta and Margareta Larson and Anders Holmefjord and Sigvor Reis{\ae}ter and Pedersen, {Nina Helen} 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 Chalien, {Midia Najar} 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",
year = "2017",
month = "2",
day = "20",
language = "English",
volume = "51",
pages = "2--13",
journal = "Journal of Plastic Surgery and Hand Surgery",
issn = "2000-656X",
publisher = "Taylor & Francis",
number = "1",

}

RIS

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