Hebebrand D, Troidl H, Spangenberger W, Neugebauer E, Schwalm T, Günther M W
II. Chirurgischer Lehrstuhl der Universität zu Köln.
Chirurg. 1994 Feb;65(2):112-20.
Though laparoscopic appendectomy started endoscopic surgery in general surgery, it has yet not reached the acceptance as is the case with cholecystectomy. The application of this technique in possibly bland appendices and reports that the technique was accompanied by severe complications, increases the scepticism about it. This made us decide to start a randomized controlled trial: laparoscopic vs. conventional appendectomy. More than 1000 endoscopic interventions mainly performed at the gallbladder and the stomach and 165 prospectively documented and partly treated patients with acute appendicitis were the basis to start this trial. "Acute Appendicitis" was diagnosed on the basis of clinical symptoms by means of the computer-aided questionnaire of the EC-study "Acute Abdominal Pain", a self-developed validated diagnostic score, the macroscopic findings and the careful assessment of the histology of the resected appendix. Beside the technical feasibility, principle end-points were mainly intensity and course of postoperative pain measured by means of the Visual Analogue Scale (VAS) in lying, standing and moving position and the postoperative consumption of analgesics. We assessed a difference of 15 points on the VAS as clinically relevant. Of 57 patients with acute appendicitis we performed open appendectomy in 23 and laparoscopy in 34 patients according to randomization. In 9 patients of the laparoscopy group it was necessary to change over to open appendectomy for different reasons resulting in a direct comparison of 25 laparoscopies versus 23 open appendectomies. There were no differences between sociodemographic and preclinical data in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)
尽管腹腔镜阑尾切除术开启了普通外科的内镜手术,但它尚未像胆囊切除术那样被广泛接受。该技术在可能为单纯性阑尾炎中的应用以及有关该技术伴有严重并发症的报道,增加了人们对它的怀疑。这促使我们决定开展一项随机对照试验:腹腔镜阑尾切除术与传统阑尾切除术对比。超过1000例主要针对胆囊和胃部的内镜干预以及165例前瞻性记录且部分接受治疗的急性阑尾炎患者是开展这项试验的基础。“急性阑尾炎”是根据临床症状,借助欧洲共同体“急性腹痛”研究的计算机辅助问卷、自行研发并经验证有效的诊断评分、宏观检查结果以及对切除阑尾组织学的仔细评估来诊断的。除了技术可行性外,主要终点指标主要是通过视觉模拟量表(VAS)在卧位、站立位和活动位测量的术后疼痛强度和过程,以及术后镇痛药的使用情况。我们将VAS上15分的差异视为具有临床意义。在57例急性阑尾炎患者中,根据随机分组,我们对23例进行了开腹阑尾切除术,对34例进行了腹腔镜手术。在腹腔镜组的9例患者中,由于各种原因有必要转为开腹阑尾切除术,从而形成了25例腹腔镜手术与23例开腹阑尾切除术的直接对比。两组的社会人口统计学和临床前数据没有差异。(摘要截取自250字)