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Open versus Closed Management of the Abdomen in the Surgical Treatment of Severe Secondary Peritonitis: A Randomized Clinical Trial

机译:严重继发性腹膜炎手术治疗中腹部的开放与封闭管理:一项随机临床试验

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Background: Despite recent advances in diagnosis, antimicrobial therapy, and intensive care support, operative treatment remains the foundation of the management of patients with severe secondary peritonitis (SSP). This management is based on three fundamental principles: (1) Elimination of the source of infection; (2) reduction of bacterial contamination of the peritoneal cavity; and (3) prevention of persistent or recurrent intra-abdominal infection. Although recent studies have emphasized the role of open management of the abdomen and planned re-laparotomies to fulfill these principles, controversy surrounds the optimal approach because no randomized studies exist. Methods: Patients with SSP, documented clinically, with calculated Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation (APACHE II) scores and appropriate ancillary studies, were allocated randomly to two groups for the management of the abdomen after operation for SSP (group A: open; group B: closed). Both surgical strategies were standardized, and patients were followed up until cure or death. Results: During a 24-month period, 40 patients with SSP were admitted for treatment. Patients in group A (n = 20) and group B (n = 20) did not differ in sex, age, site of origin (etiology), APACHE II score (24 vs. 22), SOFA score (15 vs. 15), or previous operative treatment (≤ 1:20 vs. 20). Postoperatively, there were no differences in the likelihood of acute renal failure (25 vs. 40), duration of mechanical ventilatory support (10 vs. 12 days), need for total parenteral nutrition (80 vs. 75), or rate of residual infection or need for reoperation because of the latter (15 vs. 10). Although the difference in the mortality rate (55 vs. 30) did not reach statistical significance (p < 0.05; chi-square and Fisher exact test), the relative risk and odds ratio for death were 1.83 and 2.85 times higher in group A. This clinical finding, as evidenced by the clear tendency toward a more favorable outcome for patients in group B, led to termination of the study at the first interim analysis. Conclusion: This randomized study from a single institution demonstrates that closed management of the abdomen may be a more rational approach after operative treatment of SSP and questions the recent enthusiasm for the open alternative, which has been based on observational studies.
机译:背景:尽管最近在诊断、抗菌治疗和重症监护支持方面取得了进展,但手术治疗仍然是严重继发性腹膜炎 (SSP) 患者管理的基础。这种管理基于三个基本原则:(1)消除感染源;(2)减少腹膜腔的细菌污染;(3)预防持续性或复发性腹腔内感染。尽管最近的研究强调了腹部开放管理的作用,并计划进行复剖手术以实现这些原则,但由于没有随机研究,因此围绕最佳方法存在争议。方法:将临床记录、计算出序贯器官衰竭评估 (SOFA) 和急性生理学和慢性健康评估 (APACHE II) 评分和适当的辅助研究的 SSP 患者随机分配到两组进行 SSP 手术后的腹部管理(A 组:开放;B 组:闭合)。两种手术策略都是标准化的,对患者进行随访直至治愈或死亡。结果:在24个月的时间里,40例SSP患者入院接受治疗。A组(n=20)和B组(n=20)的患者在性别、年龄、原发部位(病因)、APACHE II评分(24分对22分)、SOFA评分(15分对15分)或既往手术治疗(≤1:20对20)方面没有差异。术后,急性肾功能衰竭的可能性(25% vs. 40%)、机械通气支持的持续时间(10 vs. 12 days)、全肠外营养需求(80% vs. 75%)或残留感染率或因后者而需要再次手术(15% vs. 10%)没有差异。虽然死亡率的差异(55% vs. 30%)没有达到统计学意义(p < 0.05;卡方和Fisher精确检验),但A组的死亡相对风险和比值比分别高出1.83倍和2.85倍。这一临床发现,正如 B 组患者明显倾向于获得更有利结果所证明的那样,导致该研究在第一次中期分析中终止。结论:这项来自单一机构的随机研究表明,在 SSP 手术治疗后,封闭式腹部管理可能是一种更合理的方法,并质疑最近对基于观察性研究的开放式替代方案的热情。

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