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.
View Article and Find Full Text PDFBackground: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate, and randomised trials have only rarely been performed. The Scandcleft Project consists of three trials commenced in 1997 involving ten centres in Denmark, Finland, Norway, Sweden, and the UK. Three groups of centres tested a newly-defined common technique for palatal repair (Arm A) against their local protocols (Arms B, C, D).
View Article and Find Full Text PDFAgnathia-otocephaly complex is a malformation characterized by absent/hypoplastic mandible and abnormally positioned ears. Mutations in two genes, PRRX1 and OTX2, have been described in a small number of families with this disorder. We performed clinical and genetic testing in an additional family.
View Article and Find Full Text PDFCleft Palate Craniofac J
July 2011
Objective: We investigated the effect of the bacterial flora of the nose and throat on the outcome of the initial repairs of the cleft palate in the presence of prophylactic antibiotics.
Design: A retrospective review of 90 procedures in 66 patients who had cleft palate repair between April 2005 and June 2007 was conducted at Booth Hall Children's Hospital, Manchester, U.K.
Objective: The aim of this trial was to compare the relative effectiveness (efficacy and morbidity) of two surgical procedures for correcting velopharyngeal insufficiency (VPI).
Design: This was an international multicenter randomized trial to study the outcome of two surgical procedures (flap and sphincter pharyngoplasty) for speech, incidence of sleep apnea, and surgical complications.
Method: Ninety-seven patients 3 to 25 years old with repaired cleft palate and previously identified VPI were enrolled from five centers in the United States, Norway, and the U.