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耻骨上与经尿道导尿用于男性直肠癌手术中的膀胱引流(GRECCAR10):一项随机临床试验。

Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial.

机构信息

Colorectal Unit, Department of Surgery, Grenoble Alpes University Hospital, 38000, Grenoble, France.

TIMC-IMAG - CNRS UMR 5525, University Grenoble Alpes, 38000, Grenoble, France.

出版信息

Tech Coloproctol. 2024 Jul 2;28(1):77. doi: 10.1007/s10151-024-02950-2.

Abstract

BACKGROUND

Bladder drainage is systematically used in rectal cancer surgery; however, the optimal type of drainage, transurethral catheterization (TUC) or suprapubic catheterization (SPC), is still controversial. The aim was to compare the rates of urinary tract infection on the fourth postoperative day (POD4) between TUC and SPC, after rectal cancer surgery regardless of the day of removal of the urinary drain.

METHODS

This randomized clinical trial in 19 expert colorectal surgery centers in France and Belgium was performed between October 2016 and October 2019 and included 240 men (with normal or subnormal voiding function) undergoing mesorectal excision with low anastomosis for rectal cancer. Patients were followed at postoperative days 4, 30, and 180.

RESULTS

In 208 patients (median age 66 years [IQR 58-71]) randomized to TUC (n = 99) or SPC (n = 109), the rate of urinary infection at POD4 was not significantly different whatever the type of drainage (11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35). There was significantly more pyuria in the TUC group (79/99 (79.0%) vs. (60/109 (60.9%), 95% CI, 5.7-30.0%; p = 0.004). No difference in bacteriuria was observed between the groups. Patients in the TUC group had a shorter duration of catheterization (median 4 [2-5] vs. 4 [3-5] days; p = 0.002). Drainage complications were more frequent in the SPC group at all followup visits.

CONCLUSIONS

TUC should be preferred over SPC in male patients undergoing surgery for mid and/or lower rectal cancers, owing to the lower rate of complications and shorter duration of catheterization.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT02922647.

摘要

背景

在直肠癌手术中,系统地使用膀胱引流;然而,经尿道导管插入术(TUC)或耻骨上导管插入术(SPC)哪种是最佳类型的引流方法仍存在争议。本研究旨在比较直肠癌手术后第四天(POD4)时,TUC 和 SPC 两种引流方式下尿路感染的发生率,无论导尿管何时移除。

方法

这是一项在法国和比利时的 19 家专业结直肠外科中心进行的随机临床试验,于 2016 年 10 月至 2019 年 10 月期间进行,共纳入 240 名(排尿功能正常或低于正常)接受中低位直肠癌系膜切除术和低位吻合术的男性患者。患者在术后第 4、30 和 180 天进行随访。

结果

在 208 名(中位年龄 66 岁[IQR 58-71])随机分配至 TUC(n=99)或 SPC(n=109)的患者中,无论引流类型如何,POD4 时的尿路感染发生率无显著差异(11/99(11.1%)与 8/109(7.3%),95%CI,-4.2%至 11.7%;p=0.35)。TUC 组中更多的患者存在脓尿(79/99(79.0%)与 60/109(60.9%),95%CI,5.7-30.0%;p=0.004)。两组之间未观察到菌尿差异。TUC 组的导尿管留置时间更短(中位数 4[2-5]与 4[3-5]天;p=0.002)。在所有随访期间,SPC 组的引流并发症更为常见。

结论

由于并发症发生率较低和导尿管留置时间较短,TUC 应优于 SPC,用于接受中低位直肠癌手术的男性患者。

试验注册

ClinicalTrials.gov 标识符 NCT02922647。

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