BACKGROUND The aim of this study was to assess the efficacy of an endoluminal vacuum device (Endo-SPONGE®) in the treatment of rectal anastomotic leaks. METHODS All studies looking at endoluminal vacuum therapy with Endo-SPONGE® in the treatment of rectal anastomotic leaks were included. A comprehensive search was conducted as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Primary outcome was defined as the rate of total anastomotic salvage, with secondary outcomes including rate of ileostomy closure, additional transrectal closures and functional outcomes RESULTS: Sixteen studies met the inclusion criteria. There was a significant publication bias (z = 3.53, p = 0.0004). Two hundred sixty-six patients were identified. The median treatment failure rate was 11.8% (range 0-44%), with random effects model of 0.17 (95% CI 0.11-0.22). There was improvement with early therapy start (OR 3.48) and negative correlation with neoadjuvant radiotherapy (OR 0.56). Fifty-one percent of all diverting stomas were closed at the end of treatment period and 12.8% of patients required an additional trans-rectal closure of the abscess cavity. CONCLUSIONS Endo-SPONGE® seems to be a useful method of rectal anastomotic leak treatment in selected group of patients; however, the quality of available data is poor and it is impossible to draw a final conclusion. There is unexpected high rate of permanent ileostomy. There is a need for further assessment of this therapy with well-designed randomised or cohort studies.

中文翻译：

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Endo-SPONGE® 在直肠吻合口漏中的应用：系统评价。

背景 本研究的目的是评估腔内真空装置 (Endo-SPONGE®) 在治疗直肠吻合口漏中的疗效。方法 所有研究使用 Endo-SPONGE® 进行腔内负压治疗直肠吻合口漏的研究都被纳入。根据系统评价和元分析 (PRISMA) 指南的首选报告项目进行了全面搜索。主要结果定义为总吻合口挽救率，次要结果包括回肠造口闭合率、额外经直肠闭合率和功能结果 结果：16 项研究符合纳入标准。存在显着的发表偏倚（z = 3.53，p = 0.0004）。确定了 266 名患者。中位治疗失败率为 11.8%（范围 0-44%），随机效应模型为 0.17 (95% CI 0.11-0.22)。早期治疗开始有改善（OR 3.48），与新辅助放疗呈负相关（OR 0.56）。51% 的分流造口在治疗期结束时关闭，12.8% 的患者需要额外经直肠闭合脓腔。结论 Endo-SPONGE® 似乎是在选定的患者组中治疗直肠吻合口漏的有用方法；但是，现有数据的质量很差，无法得出最终结论。永久性回肠造口术的比率出乎意料的高。需要通过精心设计的随机或队列研究对这种疗法进行进一步评估。48）和与新辅助放疗负相关（OR 0.56）。51% 的分流造口在治疗期结束时关闭，12.8% 的患者需要额外经直肠闭合脓腔。结论 Endo-SPONGE® 似乎是在选定的患者组中治疗直肠吻合口漏的有用方法；但是，现有数据的质量很差，无法得出最终结论。永久性回肠造口术的比率出乎意料的高。需要通过精心设计的随机或队列研究对这种疗法进行进一步评估。48）和与新辅助放疗负相关（OR 0.56）。51% 的分流造口在治疗期结束时关闭，12.8% 的患者需要额外经直肠闭合脓腔。结论 Endo-SPONGE® 似乎是在选定的患者组中治疗直肠吻合口漏的有用方法；但是，现有数据的质量很差，无法得出最终结论。永久性回肠造口术的比率出乎意料的高。需要通过精心设计的随机或队列研究对这种疗法进行进一步评估。结论 Endo-SPONGE® 似乎是在选定的患者组中治疗直肠吻合口漏的有用方法；但是，现有数据的质量很差，无法得出最终结论。永久性回肠造口术的比率出乎意料的高。需要通过精心设计的随机或队列研究对这种疗法进行进一步评估。结论 Endo-SPONGE® 似乎是在选定的患者组中治疗直肠吻合口漏的有用方法；但是，现有数据的质量很差，无法得出最终结论。永久性回肠造口术的比率出乎意料的高。需要通过精心设计的随机或队列研究对这种疗法进行进一步评估。