Acute cholecystitis - a cohort study in a real-world clinical setting (REWO study, NCT02796443).

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2018-10-25 eCollection Date: 2018-01-01 DOI:10.2147/POR.S169255
Jennifer Blythe, Eva Herrmann, Dominik Faust, Stephan Falk, Tina Edwards-Lehr, Florian Stockhausen, Ernst Hanisch, Alexander Buia
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引用次数: 13

Abstract

Background: For decades, the optimal timing of surgery for acute cholecystitis has been controversial. Recent meta-analyses and population-based studies favor early surgery. One recent large randomized trial has demonstrated that a delayed approach increases morbidity and cost compared to early surgery within 24 hours of hospital admission. Since cases of severe cholecystitis were excluded from this trial, we argue that these results do not reflect real-world clinical situations. From our point of view, these results were in contrast to the clinical experience with our patients; so, we decided to analyze critically all our patients with the null hypothesis that the patients treated with a delayed cholecystectomy after an acute cholecystitis have a similar or even better outcome than those treated with an early operative approach.

Patients and methods: We retrospectively analyzed clinical data from all patients with cholecystectomies in the period between January 2006 and September 2015. A total of 1,723 patients were categorized into four groups: early (n=138): urgent surgery of patients with acute cholecystitis within the first 72 hours of the onset of symptoms; intermediate (n=297): surgery of patients with acute cholecystitis within an average of 10 days after the onset of symptoms; delayed (n=427): initial non-surgical treatment of acute cholecystitis with surgery performed within 6-12 weeks of the onset of symptoms; and elective (n=868): cholecystectomy within a symptom-free interval of choice in patients with symptomatic cholecystolithiasis without signs of acute cholecystitis.

Results: In a real-world scenario, early/intermediate cholecystectomy in acute cholecystitis was associated with a significant increase in morbidity and mortality (Clavien-Dindo score) compared to a delayed approach with surgery performed 6-12 weeks after the onset of symptoms. The adjusted linear rank statistics showed a decrease in the complication score with values of 2.29 in the early group, 0.48 in the intermediate group, -0.26 in the delayed group and -2.12 in the elective group. The results translate into a continuous decrease of the complication score from early over intermediate and delayed to the elective group.

Conclusion: These results demonstrate that delayed cholecystectomy can be performed safely. In cases with severe cholecystitis, early and/or intermediate approaches still have a relatively high risk of morbidity and mortality.

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急性胆囊炎——现实世界临床环境中的队列研究(REWO研究,NCT02796443)。
背景:几十年来,急性胆囊炎的最佳手术时机一直存在争议。最近的荟萃分析和基于人群的研究倾向于早期手术。最近的一项大型随机试验表明,与入院24小时内的早期手术相比,延迟手术会增加发病率和成本。由于严重胆囊炎病例被排除在本试验之外,我们认为这些结果并不能反映真实的临床情况。从我们的角度来看,这些结果与我们患者的临床经验相反;因此,我们决定严格分析我们所有的病人,零假设在急性胆囊炎后接受延迟胆囊切除术的病人与那些接受早期手术治疗的病人有相似甚至更好的结果。患者和方法:我们回顾性分析2006年1月至2015年9月期间所有胆囊切除术患者的临床资料。共有1723例患者被分为四组:早期(n=138):急性胆囊炎患者在症状出现后72小时内进行紧急手术;中级(n=297):急性胆囊炎患者在出现症状后平均10天内进行手术;延迟(n=427):急性胆囊炎的初始非手术治疗,在症状出现后6-12周内进行手术;选择性(n=868):在无急性胆囊炎体征的症状性胆囊结石患者的无症状间隔内选择胆囊切除术。结果:在现实世界中,急性胆囊炎的早期/中期胆囊切除术与症状出现6-12周后延迟手术相比,发病率和死亡率(Clavien-Dindo评分)显著增加。经调整线性秩统计,并发症评分降低,早期组为2.29,中间组为0.48,延迟组为-0.26,择期组为-2.12。结果转化为并发症评分从早期超过中期和延迟到择期组持续下降。结论:迟发性胆囊切除术是安全可行的。在严重胆囊炎病例中,早期和/或中期入路仍有较高的发病率和死亡率风险。
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Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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