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结直肠手术后复杂性腹腔内积液的管理(COMPASS):一项关于结直肠手术引流放置实践的多中心、观察性、前瞻性国际研究方案

Management of COMPlicAted intra-abdominal collectionS after colorectal Surgery (COMPASS): protocol for a multicentre, observational, prospective international study of drain placement practices in colorectal surgery.

出版信息

Colorectal Dis. 2020 Dec;22(12):2315-2321. doi: 10.1111/codi.15275. Epub 2020 Aug 10.

Abstract

AIM

Postoperative drains have historically been used for the prevention and early detection of intra-abdominal collections. However, current evidence suggests that prophylactic drain placement following colorectal surgery has no significant clinical benefit. This is reflected in the enhanced recovery after surgery (ERAS) guidelines, which recommend against their routine use. The Ileus Management International study found more than one-third of participating centres across the world routinely used drains in the majority of colorectal resections. The aim of the present study is to audit international compliance with ERAS guidelines regarding the use of postoperative drains in colorectal surgery.

METHOD

This prospective, multicentre audit will be conducted via the student- and trainee-led EuroSurg Collaborative network across Europe, South Africa and Australasia. Data will be collected on consecutive patients undergoing elective and emergency colorectal surgery with 30-day follow-up. This will include any colorectal resection, formation of colostomy/ileostomy and reversal of stoma. The primary end-point will be adherence to ERAS guidelines for intra-abdominal drain placement. Secondary outcomes will include the following: time to diagnosis of intra-abdominal postoperative collections; output and time to removal of drains; and 30-day postoperative complications defined by the Clavien-Dindo classification.

CONCLUSION

This protocol describes the methodology for the first international audit of intra-abdominal drain placement after colorectal surgery. The study will be conducted across a large collaborative network with quality assurance and data validation strategies. This will provide a clear understanding of current practice and novel evidence regarding the efficacy and safety of intra-abdominal drain placement in colorectal surgical patients.

摘要

目的

术后引流管一直以来都被用于预防和早期发现腹腔内积液。然而,目前的证据表明,结直肠手术后预防性放置引流管并无显著的临床益处。这在术后加速康复(ERAS)指南中有所体现,该指南不建议常规使用引流管。国际肠梗阻管理研究发现,全球超过三分之一的参与中心在大多数结直肠切除术中常规使用引流管。本研究的目的是审核国际上结直肠手术中术后引流管使用情况对ERAS指南的遵循情况。

方法

这项前瞻性、多中心审核将通过由学生和实习生主导的欧洲外科协作网络在欧洲、南非和澳大拉西亚进行。将收集接受择期和急诊结直肠手术且随访30天的连续患者的数据。这将包括任何结直肠切除术、结肠造口术/回肠造口术的形成以及造口回纳术。主要终点将是遵循ERAS指南放置腹腔引流管的情况。次要结局将包括以下方面:腹腔内术后积液的诊断时间;引流管的引流量和拔除时间;以及根据Clavien-Dindo分类定义的术后30天并发症。

结论

本方案描述了结直肠手术后腹腔引流管放置的首次国际审核方法。该研究将在一个大型协作网络中进行,并采用质量保证和数据验证策略。这将清晰了解当前的实践情况,并提供关于结直肠手术患者腹腔引流管放置的有效性和安全性的新证据。

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