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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 2. Surgical results.
J Plast Surg Hand Surg. 2017 Feb; 51(1):14-20.JP

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.

Authors+Show Affiliations

a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland.b Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.b Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland.c Center for Cleft Lip and Palate , Bergen University Hospital Haukeland , Bergen , Norway.d Department of Plastic Surgery , Royal Manchester Children's Hospital , Manchester , UK.e Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet Oslo , Norway.f Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.g Department of Plastic Surgery , University Hospital , Linköping , Sweden.e Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet Oslo , Norway.d Department of Plastic Surgery , Royal Manchester Children's Hospital , Manchester , UK.h The Royal Hospital for Sick Children , Belfast , N. Ireland.i Department of Plastic Surgery , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Sweden.f Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.i Department of Plastic Surgery , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Sweden.a Cleft Palate and Craniofacial Center, Department of Plastic Surgery , Helsinki University Hospital , Helsinki , Finland.j University of Manchester , Manchester , UK.k Dental School , University of Manchester , Manchester , UK. l Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet, Statped sørøst , Oslo , Norway.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Review

Language

eng

PubMed ID

28218552

Citation

Rautio, Jorma, et al. "Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 2. Surgical Results." Journal of Plastic Surgery and Hand Surgery, vol. 51, no. 1, 2017, pp. 14-20.
Rautio J, Andersen M, Bolund S, et al. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 2. Surgical results. J Plast Surg Hand Surg. 2017;51(1):14-20.
Rautio, J., Andersen, M., Bolund, S., Hukki, J., Vindenes, H., Davenport, P., Arctander, K., Larson, O., Berggren, A., Åbyholm, F., Whitby, D., Leonard, A., Lilja, J., Neovius, E., Elander, A., Heliövaara, A., Eyres, P., & Semb, G. (2017). Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 2. Surgical results. Journal of Plastic Surgery and Hand Surgery, 51(1), 14-20. https://doi.org/10.1080/2000656X.2016.1254646
Rautio J, et al. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 2. Surgical Results. J Plast Surg Hand Surg. 2017;51(1):14-20. PubMed PMID: 28218552.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 2. Surgical results. AU - Rautio,Jorma, AU - Andersen,Mikael, AU - Bolund,Stig, AU - Hukki,Jyri, AU - Vindenes,Hallvard, AU - Davenport,Peter, AU - Arctander,Kjartan, AU - Larson,Ola, AU - Berggren,Anders, AU - Åbyholm,Frank, AU - Whitby,David, AU - Leonard,Alan, AU - Lilja,Jan, AU - Neovius,Erik, AU - Elander,Anna, AU - Heliövaara,Arja, AU - Eyres,Phil, AU - Semb,Gunvor, PY - 2017/2/21/entrez PY - 2017/2/22/pubmed PY - 2017/12/16/medline KW - Cleft lip and palate KW - palatal fistula KW - surgical technique KW - velopharyngeoplasty rate SP - 14 EP - 20 JF - Journal of plastic surgery and hand surgery JO - J Plast Surg Hand Surg VL - 51 IS - 1 N2 - 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. SN - 2000-6764 UR - https://www.unboundmedicine.com/medline/citation/28218552/Scandcleft_randomised_trials_of_primary_surgery_for_unilateral_cleft_lip_and_palate:_2__Surgical_results_ L2 - http://www.tandfonline.com/doi/full/10.1080/2000656X.2016.1254646 DB - PRIME DP - Unbound Medicine ER -