男性直肠癌手术中膀胱引流的耻骨上导尿与经尿道导尿(GRECCAR10),一项随机临床试验。

IF 2.7 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Techniques in Coloproctology Pub Date : 2024-07-02 DOI:10.1007/s10151-024-02950-2
B Trilling, F Tidadini, Z Lakkis, M Jafari, A Germain, E Rullier, J Lefevre, J J Tuech, A Kartheuser, D Leonard, M Prudhomme, G Piessen, J M Regimbeau, E Cotte, D Duprez, B Badic, Y Panis, M Rivoire, B Meunier, G Portier, J L Bosson, A Vilotitch, A Foote, Y Caspar, P Rouanet, J L Faucheron
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引用次数: 0

摘要

背景:膀胱引流被系统地用于直肠癌手术;然而,最佳引流方式是经尿道导尿(TUC)还是耻骨上导尿(SPC)仍存在争议。本研究旨在比较直肠癌手术后经尿道导尿和经耻骨上导尿两种引流方式在术后第四天(POD4)的尿路感染率,无论引流管是在哪一天拔除的:这项随机临床试验于2016年10月至2019年10月期间在法国和比利时的19个结肠直肠外科专家中心进行,共纳入240名男性(排尿功能正常或不正常),他们因直肠癌接受了直肠系膜切除术和低位吻合术。术后第4天、第30天和第180天对患者进行了随访:在 208 名随机接受 TUC(99 人)或 SPC(109 人)治疗的患者(中位年龄 66 岁 [IQR 58-71])中,无论采用哪种引流方式,POD4 的泌尿系统感染率都没有显著差异(11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35)。TUC组出现脓尿的比例明显更高(79/99(79.0%)对 60/109(60.9%),95% CI,5.7%-30.0%;P = 0.004)。两组患者的菌尿没有差异。TUC组患者的导尿时间较短(中位 4 [2-5] 天 vs. 4 [3-5] 天;p = 0.002)。在所有随访中,SPC 组的引流并发症发生率更高:结论:对于接受中段和/或下段直肠癌手术的男性患者,TUC应优于SPC,因为TUC的并发症发生率更低,导尿时间更短:试验注册:ClinicalTrials.gov标识符NCT02922647。
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Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial.

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.

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来源期刊
Techniques in Coloproctology
Techniques in Coloproctology GASTROENTEROLOGY & HEPATOLOGY-SURGERY
CiteScore
5.30
自引率
9.10%
发文量
176
审稿时长
1 months
期刊介绍: Techniques in Coloproctology is an international journal fully devoted to diagnostic and operative procedures carried out in the management of colorectal diseases. Imaging, clinical physiology, laparoscopy, open abdominal surgery and proctoperineology are the main topics covered by the journal. Reviews, original articles, technical notes and short communications with many detailed illustrations render this publication indispensable for coloproctologists and related specialists. Both surgeons and gastroenterologists are represented on the distinguished Editorial Board, together with pathologists, radiologists and basic scientists from all over the world. The journal is strongly recommended to those who wish to be updated on recent developments in the field, and improve the standards of their work. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1965 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the Principles of Laboratory Animal Care (NIH publication no. 86-23 revised 1985) were followed as were applicable national laws (e.g. the current version of the German Law on the Protection of Animals). The Editor-in-Chief reserves the right to reject manuscripts that do not comply with the above-mentioned requirements. Authors will be held responsible for false statements or for failure to fulfill such requirements.
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