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DOI 10.1080/2000656x.2016.1263202

Медицинская библиотека · Journal of plastic surgery and hand surgery · 2017

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

Semb Gunvor, Enemark Hans, Friede Hans, Paulin Gunnar, Lilja Jan, Rautio Jorma, Andersen Mikael, Åbyholm Frank, Lohmander Anette, Shaw William, Mølsted Kirsten, Heliövaara Arja, Bolund Stig, Hukki Jyri, Vindenes Hallvard, Davenport Peter, Arctander Kjartan, Larson Ola, Berggren Anders, 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

Сравнительное исследованиеСтатьяМногоцентровое исследованиеОбзорПеревод в очереди

Аннотация

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.

Для цитирования: Semb Gunvor, Enemark Hans, Friede Hans, Paulin Gunnar, Lilja Jan, Rautio Jorma, Andersen Mikael, Åbyholm Frank, Lohmander Anette, Shaw William, Mølsted Kirsten, Heliövaara Arja, Bolund Stig, Hukki Jyri, Vindenes Hallvard, Davenport Peter, Arctander Kjartan, Larson Ola, Berggren Anders, 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. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.. Journal of plastic surgery and hand surgery. 2017. DOI: 10.1080/2000656x.2016.1263202.

Предметные рубрики MeSH

Chi-Square DistributionChild, PreschoolCleft LipCleft PalateDisease ManagementEstheticsFemaleFollow-Up StudiesHealth PlanningHumansInfantMaleObserver VariationPostoperative ComplicationsQuality of LifeRandomized Controlled Trials as TopicPlastic Surgery ProceduresRisk AssessmentTreatment Outcome
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