Jorma Rautio1, Mikael Andersen2, Stig Bolund2, Jyri Hukki1, Hallvard Vindenes3, Peter Davenport4, Kjartan Arctander5, Ola Larson6, Anders Berggren7, Frank Åbyholm5, David Whitby4, Alan Leonard8, Jan Lilja9, Erik Neovius6, Anna Elander9, Arja Heliövaara1, Phil Eyres10, Gunvor Semb11,12. 1. a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland. 2. b Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark. 3. c Center for Cleft Lip and Palate , Bergen University Hospital Haukeland , Bergen , Norway. 4. d Department of Plastic Surgery , Royal Manchester Children's Hospital , Manchester , UK. 5. e Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet Oslo , Norway. 6. f Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden. 7. g Department of Plastic Surgery , University Hospital , Linköping , Sweden. 8. h The Royal Hospital for Sick Children , Belfast , N. Ireland. 9. i Department of Plastic Surgery , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Sweden. 10. j University of Manchester , Manchester , UK. 11. k Dental School , University of Manchester , Manchester , UK. 12. l Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet, Statped sørøst , Oslo , Norway.
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. AIM: 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. METHOD: 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. TRIAL REGISTRATION: ISRCTN29932826.
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. AIM: 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. METHOD: 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. TRIAL REGISTRATION: ISRCTN29932826.
Authors: Robin Bruggink; Frank Baan; Gem Kramer; Colet Claessens; Anne Marie Kuijpers-Jagtman; Ewald M Bronkhorst; Thomas J J Maal; Edwin Ongkosuwito Journal: PeerJ Date: 2020-07-30 Impact factor: 2.984
Authors: Abdul Latif; Mette A R Kuijpers; Martin Rachwalski; Benny S Latief; Anne Marie Kuijpers-Jagtman; Piotr S Fudalej Journal: J Anat Date: 2019-12-02 Impact factor: 2.610