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A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.
J Plast Surg Hand Surg. 2017 Feb; 51(1):2-13.JP

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.

Authors+Show Affiliations

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.d Cleft Palate Center , Aarhus , Denmark.e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.f Department of Dentofacial Orthopedics , University Hospital , Linköping , Sweden.g Department of Plastic Surgery , Sahlgrenska Academy, University of Gothenburg , Sweden.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.j Division of Speech and Language Pathology , Karolinska Institute, and Karolinska University Hospital , Stockholm , Sweden.a Division of Dentistry, University of Manchester , Manchester , UK.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.k Centre for Cleft Lip and Palate, Bergen University Hospital Haukeland , Bergen , Norway.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.n Department of Plastic Surgery , University Hospital , Linköping , Sweden.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.o The Royal Hospital for Sick Children , Belfast , N. Ireland.m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.g Department of Plastic Surgery , Sahlgrenska Academy, University of Gothenburg , Sweden.p Department of Nordic Studies and Linguistics , University of Copenhagen , Denmark.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.q Private Practitioner , Manchester , UK.m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.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.a Division of Dentistry, University of Manchester , Manchester , UK.d Cleft Palate Center , Aarhus , Denmark.a Division of Dentistry, University of Manchester , Manchester , UK.a Division of Dentistry, University of Manchester , Manchester , UK.a Division of Dentistry, University of Manchester , Manchester , UK.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.i Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Denmark.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.h Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.c Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.l Greater Manchester Cleft Lip and Palate Unit , Royal Manchester Childrens' Hospital , Manchester , UK.m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.t Stockholm Craniofacial Team, Department of Dental Medicine , Karolinska Institute , Stockholm , Sweden.u Eastman Institute, Stockholms Läns Landsting , Stockholm , Sweden.v Statped vest , Bergen , Norway.v Statped vest , Bergen , Norway.v Statped vest , Bergen , Norway.v Statped vest , Bergen , Norway.w Dental School, University of Bergen , Bergen , Norway.x Oral Health Center of Expertise/Western Norway , Bergen , Norway.k Centre for Cleft Lip and Palate, Bergen University Hospital Haukeland , Bergen , Norway.k Centre for Cleft Lip and Palate, Bergen University Hospital Haukeland , Bergen , Norway.s Division for Speech and Language Pathology , Sahlgrenska University Hospital , Gothenburg , Sweden.e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.e Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.g Department of Plastic Surgery , Sahlgrenska Academy, University of Gothenburg , Sweden.y Division of Speech and Language Pathology , Linköping University , Linköping , Sweden.f Department of Dentofacial Orthopedics , University Hospital , Linköping , Sweden.n Department of Plastic Surgery , University Hospital , Linköping , Sweden.f Department of Dentofacial Orthopedics , University Hospital , Linköping , Sweden.o The Royal Hospital for Sick Children , Belfast , N. Ireland.o The Royal Hospital for Sick Children , Belfast , N. Ireland.o The Royal Hospital for Sick Children , Belfast , N. Ireland.o The Royal Hospital for Sick Children , Belfast , N. Ireland.a Division of Dentistry, University of Manchester , Manchester , UK.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Review

Language

eng

PubMed ID

28218559

Citation

Semb, Gunvor, et al. "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, 2017, pp. 2-13.
Semb G, Enemark H, Friede H, et al. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management. J Plast Surg Hand Surg. 2017;51(1):2-13.
Semb, G., Enemark, H., Friede, H., Paulin, G., Lilja, J., Rautio, J., Andersen, M., Åbyholm, F., Lohmander, A., Shaw, W., Mølsted, K., Heliövaara, A., Bolund, S., Hukki, J., Vindenes, H., Davenport, P., Arctander, K., Larson, O., Berggren, A., ... Worthington, H. (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
Semb G, et al. A Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 1. Planning and Management. J Plast Surg Hand Surg. 2017;51(1):2-13. PubMed PMID: 28218559.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 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 - Mølsted,Kirsten, AU - Heliövaara,Arja, AU - Bolund,Stig, AU - Hukki,Jyri, AU - Vindenes,Hallvard, 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,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, PY - 2017/2/21/entrez PY - 2017/2/22/pubmed PY - 2017/12/16/medline KW - Scandcleft Project KW - multicentre study KW - randomised controlled trials KW - surgery for unilateral complete cleft lip and palate SP - 2 EP - 13 JF - Journal of plastic surgery and hand surgery JO - J Plast Surg Hand Surg VL - 51 IS - 1 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. SN - 2000-6764 UR - https://www.unboundmedicine.com/medline/citation/28218559/A_Scandcleft_randomised_trials_of_primary_surgery_for_unilateral_cleft_lip_and_palate:_1__Planning_and_management_ L2 - http://www.tandfonline.com/doi/full/10.1080/2000656X.2016.1263202 DB - PRIME DP - Unbound Medicine ER -