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A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.
Division of Dentistry, University of Manchester , Manchester , UK; Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway; Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway..
Cleft Palate Center , Aarhus , Denmark.
Department of Orthodontics , Sahlgrenska Academy, University of Gothenburg , Sweden.
Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Maxillofacial Unit.
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2017 (English)In: Journal of Plastic Surgery and Hand Surgery, ISSN 2000-656X, E-ISSN 2000-6764, Vol. 51, no 1, 2-13 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Taylor & Francis, 2017. Vol. 51, no 1, 2-13 p.
Keyword [en]
Scandcleft Project, multicentre study, randomised controlled trials, surgery for unilateral complete cleft lip and palate
National Category
Surgery
Identifiers
URN: urn:nbn:se:liu:diva-135511DOI: 10.1080/2000656X.2016.1263202ISI: 000395170100002PubMedID: 28218559OAI: oai:DiVA.org:liu-135511DiVA: diva2:1082360
Note

Funding agencies: University of Manchester; University Hospital Rikshospitalet; Statped sorost, Oslo; European Commission Biomed II Programme; European Commission Framework V Programme; Swedish Research Council for Health, Working Life and Welfare [2011-1443]

Available from: 2017-03-16 Created: 2017-03-16 Last updated: 2017-11-29

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Paulin, GunnarBerggren, AndersLundeborg, IngerMarcusson, AgnetaMjönes, Anna-Britta
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Maxillofacial UnitDepartment of Hand and Plastic SurgeryDivision of Neuro and Inflammation ScienceFaculty of Medicine and Health SciencesDepartment of Otorhinolaryngology in Linköping
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Journal of Plastic Surgery and Hand Surgery
Surgery

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