Rautio Jorma, Andersen Mikael, Bolund Stig, Hukki Jyri, Vindenes Hallvard, Davenport Peter, Arctander Kjartan, Larson Ola, Berggren Anders, Åbyholm Frank, Whitby David, Leonard Alan, Lilja Jan, Neovius Erik, Elander Anna, Heliövaara Arja, Eyres Phil, Semb Gunvor
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.
J Plast Surg Hand Surg. 2017 Feb;51(1):14-20. doi: 10.1080/2000656X.2016.1254646.
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.
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.
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.
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.
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.
ISRCTN29932826.
对于单侧唇腭裂手术方案的选择，长期以来一直存在不确定性，而且很少进行随机试验。斯堪的纳维亚腭裂项目由1997年开始的三项试验组成，涉及丹麦、芬兰、挪威、瑞典和英国的十个中心。三组中心将一种新定义的腭裂修复通用技术（A组）与其当地方案（B、C、D组）进行了对比。A组技术为试验1中的大多数外科医生所熟悉，但其他试验中的外科医生并不熟悉。
评估参与三项试验的448例（293例男孩，155例女孩）完全性单侧唇腭裂（UCLP）患者的手术情况及并发症。
三项试验按照一个全面制定且经伦理批准的方案并行开展。外科医生记录了两次初次手术期间及术后的手术时间、出血量、并发症和主要裂开情况。评估了瘘管发生率以及腭咽闭合不全（VPI）的手术治疗率，直至研究中最年幼的患者年满9岁。采用Pearson卡方统计分析比较结果。
试验1中，不同组之间在出血、感染、麻醉并发症或住院时间方面未发现显著差异。然而，在试验2和试验3中，A组的气道问题比传统的当地方案（C组或D组）更多。在试验3中，A组的瘘管和VPI手术率也更高。
结果未提供任何统计学证据表明任何一种技术优于其他技术，但表明对于仍在积累不熟悉手术方案经验的外科医生来说，手术存在更多问题。
ISRCTN29932826
