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腹腔镜阑尾切除术还是开腹阑尾切除术?随机对照试验的批判性综述。

Laparoscopic or open appendectomy? Critical review of randomized, controlled trials.

作者信息

Slim K, Pezet D, Chipponi J

机构信息

Department of General and Digestive Surgery, Hôtel-Dieu, Clermont-Ferrand, France.

出版信息

Dis Colon Rectum. 1998 Mar;41(3):398-403. doi: 10.1007/BF02237500.

Abstract

PURPOSE

A randomized, controlled trial is considered to be the "gold standard" to evaluate a new procedure. Thus, this critical review assessed whether the published randomized trials on laparoscopic appendectomy show that it is superior to the open approach.

METHODS

Twelve original articles involving a randomized, controlled trial on laparoscopic appendectomy in adults published between January 1990 and December 1996 were selected. We studied first whether each trial was positive (a procedure is superior to the other) or negative (no difference). We reviewed for each trial the methodology used and the following outcomes: operating time, intraoperative and postoperative complications, time until resumption of diet, postoperative pain, hospital stay, cost, and quality of life analyses. Postoperative morbidity was considered as the major primary outcome.

RESULTS

There were six positive and six negative trials. Postoperative complication rates were similar, but the two approaches had specific potential complications, wound infections following open appendectomy, and intra-abdominal abscesses following laparoscopic appendectomy. This review failed to show a superiority of the laparoscopy for the other outcomes, particularly postoperative pain.

CONCLUSION

Differences in positive trials concerned subjective and controversial outcomes, and the flaw in negative trials was their lack of power. Thus, nothing is definitively well established, even after 12 randomized trials.

摘要

目的

随机对照试验被认为是评估一种新手术方法的“金标准”。因此,本综述评估了已发表的关于腹腔镜阑尾切除术的随机试验是否表明其优于开放手术方法。

方法

选取了1990年1月至1996年12月间发表的12篇关于成人腹腔镜阑尾切除术随机对照试验的原始文章。我们首先研究每项试验是阳性(一种手术方法优于另一种)还是阴性(无差异)。我们对每项试验所采用的方法以及以下结果进行了综述:手术时间、术中及术后并发症、恢复饮食的时间、术后疼痛、住院时间、费用以及生活质量分析。术后发病率被视为主要的主要结果。

结果

有6项阳性试验和6项阴性试验。术后并发症发生率相似,但两种手术方法有特定的潜在并发症,开放阑尾切除术后有伤口感染,腹腔镜阑尾切除术后有腹腔内脓肿。本综述未能显示腹腔镜手术在其他结果方面的优越性,尤其是术后疼痛。

结论

阳性试验中的差异涉及主观且有争议的结果,阴性试验的缺陷在于其效能不足。因此,即使经过12项随机试验,也没有什么是确凿无疑的。

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