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门诊与住院治疗单纯性憩室炎的前瞻性、多中心随机临床试验(DIVER 试验)。

Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial).

机构信息

*Department of General and Digestive Surgery--Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain †Department of General and Digestive Surgery-Colorectal Unit, Vall d'Hebron University Hospital, Barcelona, Spain ‡Department of General and Digestive Surgery-Colorectal Unit, Virgen del Camino Hospital, Pamplona, Spain §Department of General and Digestive Surgery--Colorectal Unit, Josep Trueta University Hospital, Girona, Spain; and ‖Surgery-Colorectal Unit, Hospital Clinico Universitario, Valencia, Spain.

出版信息

Ann Surg. 2014 Jan;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.

DOI:10.1097/SLA.0b013e3182965a11
PMID:23732265
Abstract

OBJECTIVE

We compare the results of 2 different strategies for the management of patients with uncomplicated left colonic diverticulitis and to analyze differences in quality of life and economic costs.

BACKGROUND

The most frequent standard management of acute uncomplicated diverticulitis still is hospital admission both in Europe and United States.

METHODS

This multicenter, randomized controlled trial included patients older than 18 years with acute uncomplicated diverticulitis. All the patients underwent abdominal computed tomography. There were 2 strategies of management: hospitalization (group 1) and outpatient (group 2). The first dose of antibiotic was given intravenously to all patients in the emergency department and then group 1 patients were hospitalized whereas patients in group 2 were discharged. The primary end point was the treatment failure rate of the outpatient protocol and need for hospital admission. The secondary end points included quality-of-life assessment and evaluation of costs.

RESULTS

A total of 132 patients were randomized: 4 patients in group 1 and 3 patients in group 2 presented treatment failure without differences between the groups (P=0.619). The overall health care cost per episode was 3 times lower in group 2, with savings of €1124.70 per patient. No differences were observed between the groups in terms of quality of life.

CONCLUSIONS

Outpatient treatment is safe and effective in selected patients with uncomplicated acute diverticulitis. Outpatient treatment allows important costs saving to the health systems without negative influence on the quality of life of patients with uncomplicated diverticulitis. Trial registration ID: EudraCT number 2008-008452-17.

摘要

目的

我们比较了两种不同策略治疗单纯性左结肠憩室炎患者的结果,并分析了生活质量和经济成本的差异。

背景

在欧洲和美国,急性单纯性憩室炎最常见的标准治疗方法仍然是住院治疗。

方法

这项多中心、随机对照试验纳入了年龄大于 18 岁的急性单纯性憩室炎患者。所有患者均行腹部计算机断层扫描。有两种治疗策略:住院治疗(第 1 组)和门诊治疗(第 2 组)。所有患者在急诊科均给予首剂静脉抗生素,然后第 1 组患者住院,而第 2 组患者出院。主要终点是门诊方案的治疗失败率和住院需求。次要终点包括生活质量评估和成本评估。

结果

共随机分配了 132 例患者:第 1 组中有 4 例和第 2 组中有 3 例患者治疗失败,但两组之间无差异(P=0.619)。第 2 组每例患者的整体医疗费用降低了 3 倍,为 1124.70 欧元。两组患者的生活质量无差异。

结论

在选择的单纯性急性憩室炎患者中,门诊治疗是安全有效的。门诊治疗可使卫生系统节省大量费用,而不会对单纯性憩室炎患者的生活质量产生负面影响。试验注册号:EudraCT 编号 2008-008452-17。

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