Kapischke M, Caliebe A, Tepel J, Schulz T, Hedderich J
Department of General and Thoracic Surgery, University Hospital of Schleswig-Holstein, Campus Kiel, Arnold Heller Strasse 07, D-24105 Kiel, Germany.
Surg Endosc. 2006 Jul;20(7):1060-8. doi: 10.1007/s00464-005-0016-x. Epub 2006 May 13.
The benefit of laparoscopic appendicectomy remains unclear. We have analysed available randomised studies comparing laparoscopic and open appendicectomy regarding their clinical pitfalls and statistical relevance.
Thirty eight studies were analysed in terms of the following aspects: A. clinical problems (e.g., expertise of the surgeons, pre- and postoperative antibiotic treatment, definition of complications, blinding of outcomes) and B. statistical problems (e.g., definition of primary and secondary outcomes, power and sample size, statistical methods, confidence intervals, comparability of groups and studies).
Most of the studies have clinical and statistical pitfalls. The most important pitfalls are the uncertain expertise of the operating surgeons, blinding, and the exploratory nature of the studies. Our analysis aims at giving useful information for the appraisal of existing studies and the conduct of further studies. It also gives some preliminary results.
More than twenty years after Semm performed the first laparoscopic appendicectomy, it is necessary to clarify the superiority of laparoscopic or open appendectomy with well-defined, carefully designed randomised studies.
腹腔镜阑尾切除术的益处仍不明确。我们分析了现有的比较腹腔镜阑尾切除术和开腹阑尾切除术的随机研究,探讨了它们的临床缺陷和统计学相关性。
从以下几个方面分析了38项研究:A. 临床问题(如外科医生的专业技能、术前和术后抗生素治疗、并发症的定义、结果的盲法评估)和B. 统计学问题(如主要和次要结局的定义、检验效能和样本量、统计方法、置信区间、组间和研究间的可比性)。
大多数研究存在临床和统计学缺陷。最重要的缺陷是手术医生的专业技能不确定、盲法评估以及研究的探索性。我们的分析旨在为评估现有研究和开展进一步研究提供有用信息。同时也给出了一些初步结果。
在Semm首次实施腹腔镜阑尾切除术二十多年后,有必要通过精心设计的明确随机研究来阐明腹腔镜阑尾切除术或开腹阑尾切除术的优越性。