title: Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 2. Surgical results.
abstract: BACKGROUND
  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). Arm A was familiar to most of the surgeons in Trial 1, but not to the surgeons in the other Trials.
  
  
  OBJECTIVE
  To evaluate surgical events and complications of the 448 (293 boys, 155 girls) patients with complete unilateral cleft lip and palate (UCLP) enrolled in the three trials.
  
  
  METHODS
  The three trials were carried out in parallel in adherence with a fully developed, ethically approved protocol. Operative time, bleeding, complications, and major dehiscence during and after both primary surgeries were recorded by the surgeon. Rates of fistula and surgery for velopharyngeal incompetence (VPI) were assessed until the youngest patient of the study had reached the age of 9 years. Pearson Chi-square statistical analysis was used to compare the outcomes.
  
  
  RESULTS
  No significant differences in bleeding, infection, anaesthetic complications or length of hospital stay between the different arms were found for Trial 1. However, in Trials 2 and 3 there were more airway problems in Arm A than with the traditional local protocols (Arms C or D). In Trial 3 fistula and VPI surgery rates were also higher in Arm A.
  
  
  CONCLUSIONS
  The results do not provide statistical evidence that any technique is better than others, but indicate that surgery was more problematic for surgeons who were still gaining experience with an unfamiliar surgical protocol.
  
  
  BACKGROUND
  ISRCTN29932826.
authors.affiliation: a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland.
authors.forename: Jorma
authors.initials: J
authors.lastname: Rautio
authors.affiliation: b Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.
authors.forename: Mikael
authors.initials: M
authors.lastname: Andersen
authors.affiliation: b Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.
authors.forename: Stig
authors.initials: S
authors.lastname: Bolund
authors.affiliation: a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland.
authors.forename: Jyri
authors.initials: J
authors.lastname: Hukki
authors.affiliation: c Center for Cleft Lip and Palate , Bergen University Hospital Haukeland , Bergen , Norway.
authors.forename: Hallvard
authors.initials: H
authors.lastname: Vindenes
authors.affiliation: d Department of Plastic Surgery , Royal Manchester Children's Hospital , Manchester , UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Davenport
authors.affiliation: e Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet Oslo , Norway.
authors.forename: Kjartan
authors.initials: K
authors.lastname: Arctander
authors.affiliation: f Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Ola
authors.initials: O
authors.lastname: Larson
authors.affiliation: g Department of Plastic Surgery , University Hospital , Linköping , Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Berggren
authors.affiliation: e Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet Oslo , Norway.
authors.forename: Frank
authors.initials: F
authors.lastname: Åbyholm
authors.affiliation: d Department of Plastic Surgery , Royal Manchester Children's Hospital , Manchester , UK.
authors.forename: David
authors.initials: D
authors.lastname: Whitby
authors.affiliation: h The Royal Hospital for Sick Children , Belfast , N. Ireland.
authors.forename: Alan
authors.initials: A
authors.lastname: Leonard
authors.affiliation: i Department of Plastic Surgery , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Lilja
authors.affiliation: f Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Neovius
authors.affiliation: i Department of Plastic Surgery , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Elander
authors.affiliation: a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland.
authors.forename: Arja
authors.initials: A
authors.lastname: Heliövaara
authors.affiliation: j University of Manchester , Manchester , UK.
authors.forename: Phil
authors.initials: P
authors.lastname: Eyres
authors.affiliation: k Dental School , University of Manchester , Manchester , UK.|l Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet, Statped sørøst , Oslo , Norway.
authors.forename: Gunvor
authors.initials: G
authors.lastname: Semb
mesh_terms: D002675:Child, Preschool; D002971:Cleft Lip / Q000175:diagnosis / Q000601:surgery*; D002972:Cleft Palate / Q000175:diagnosis / Q000601:surgery*; D003718:Denmark; D005260:Female; D005387:Finland; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D018570:Risk Assessment; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome; D014681:Velopharyngeal Insufficiency / Q000209:etiology* / Q000503:physiopathology / Q000628:therapy
keywords: Cleft lip and palate; palatal fistula; surgical technique; velopharyngeoplasty rate