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预防性负压伤口治疗在结直肠癌患者回肠造口术后的应用:一项随机对照试验。

Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial.

机构信息

2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.

出版信息

Tech Coloproctol. 2021 Feb;25(2):185-193. doi: 10.1007/s10151-020-02372-w. Epub 2020 Nov 7.

Abstract

BACKGROUND

The aim of this study was to assess the usefulness of protective negative-pressure wound therapy (NPWT) in the reduction of wound healing complications (WHC) and surgical site infections (SSI) after diverting ileostomy closure in patients who underwent surgery for colorectal cancer.

METHODS

In this prospective randomized clinical trial in a tertiary academic surgical center, patients who had colorectal cancer surgery with protective loop ileostomy and were scheduled to undergo ileostomy closure with primary wound closure from January 2016 to December 2018 were randomized to be treated with or without NPWT. The primary endpoint was the incidence of WHC. Secondary endpoints were incidence of SSI, length of postoperative hospital stay (LOS), and length of complete wound healing (CWH) time.

RESULTS

We enrolled 35 patients NPWT (24 males [68.6%]; mean age 61.6 ± 11.3 years), with NPWT and 36 patients (20 males [55.6%]; mean age 62.4 ± 11.3 years) with only primary wound closure (control group). WHC was observed in 11 patients (30.6%) in the control group and 3 (8.57%) in the NPWT group (p = 0.020). Patients in the NPWT group had a significantly lower incidence of SSI (2 [5.71%] vs. 8 [22.2%] in the control group; p = 0.046) as well as significantly shorter median CWH (7 [7-7] days vs. 7 [7-15.5] days, p = 0.030). There was no difference in median LOS between groups (3 [2.5-5] days in the control group vs. 4 [2-4] days in the NPWT group; p = 0.072).

CONCLUSIONS

Prophylactic postoperative NPWT after diverting ileostomy closure in colorectal cancer patients reduces the incidence of WRC and SSI.

CLINICAL TRIAL REGISTRATION

clinicaltrials.gov (NCT04088162).

摘要

背景

本研究旨在评估保护性负压伤口治疗(NPWT)在减少接受结直肠手术后行保护性回肠造口关闭术患者的伤口愈合并发症(WHC)和手术部位感染(SSI)方面的有效性。

方法

在一家三级学术外科中心进行的前瞻性随机临床试验中,对 2016 年 1 月至 2018 年 12 月接受结直肠手术并计划进行保护性回肠造口关闭术和一期伤口闭合的患者进行随机分组,分别接受 NPWT 或不接受 NPWT。主要终点是 WHC 的发生率。次要终点是 SSI 的发生率、术后住院时间(LOS)和完全伤口愈合(CWH)时间的长度。

结果

我们纳入了 35 例 NPWT 组(24 例男性[68.6%];平均年龄 61.6±11.3 岁)和 36 例仅接受一期伤口闭合的对照组(20 例男性[55.6%];平均年龄 62.4±11.3 岁)。对照组中有 11 例(30.6%)发生 WHC,NPWT 组有 3 例(8.57%)(p=0.020)。NPWT 组 SSI 的发生率显著较低(2 例[5.71%]与对照组的 8 例[22.2%];p=0.046),CWH 的中位数也显著较短(7 [7-7]天与 7 [7-15.5]天,p=0.030)。两组的 LOS 中位数无差异(对照组为 3 [2.5-5]天与 NPWT 组的 4 [2-4]天;p=0.072)。

结论

结直肠手术后保护性回肠造口关闭术后预防性应用 NPWT 可降低 WHC 和 SSI 的发生率。

临床试验注册

clinicaltrials.gov(NCT04088162)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d65/7884579/725fb9adacd8/10151_2020_2372_Fig1_HTML.jpg

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