腹腔镜与传统阑尾切除术序贯设计的随机对照试验

Randomized controlled trial with sequential design of laparoscopic versus conventional appendicectomy.

作者信息

Reiertsen O, Larsen S, Trondsen E, Edwin B, Faerden A E, Rosseland A R

机构信息

Department of Surgery, Akershus Central Hospital, Nordbyhagen, Norway.

出版信息

Br J Surg. 1997 Jun;84(6):842-7.

PMID:9189105

Abstract

BACKGROUND

A prospective study including 272 patients with suspected appendicitis was performed. The aims were to evaluate the representativity of the study group and to compare diagnostic and therapeutic laparoscopy with conventional appendicectomy.

METHODS

The study was an open, randomized, single-centre trial with sequential design. One hundred and eight patients were randomized between laparoscopy or conventional appendicectomy, of whom 84 had acute appendicitis. Duration of postoperative convalescence was the major endpoint.

RESULTS

The study patients were representative of the eligible population regarding age and stage of appendicitis. The risk of unnecessary appendicectomy was significantly (P = 0.03) lower after laparoscopy. The mean difference in duration of postoperative convalescence was 4.7 days in favour of of laparoscopic appendicectomy (P = 0.07), and 26 min in duration of operation in favour of conventional appendicectomy (P < 0.01). No differences were detected in postoperative hospital stay, pain assessment or complications.

CONCLUSION

The laparoscopic procedure is at least as good as conventional appendicectomy. Initial laparoscopy reduces the rate of misdiagnosis.

摘要

背景

开展了一项纳入272例疑似阑尾炎患者的前瞻性研究。目的是评估研究组的代表性，并比较诊断性和治疗性腹腔镜检查与传统阑尾切除术。

方法

该研究是一项采用序贯设计的开放性、随机、单中心试验。108例患者被随机分为接受腹腔镜检查或传统阑尾切除术，其中84例患有急性阑尾炎。术后康复时间是主要终点指标。

结果

研究患者在年龄和阑尾炎阶段方面代表了符合条件的人群。腹腔镜检查后不必要阑尾切除术的风险显著降低（P = 0.03）。术后康复时间的平均差异为4.7天，有利于腹腔镜阑尾切除术（P = 0.07），手术时间差异为26分钟，有利于传统阑尾切除术（P < 0.01）。在术后住院时间、疼痛评估或并发症方面未检测到差异。