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直肠癌手术患者早期拔除尿管:一项关于西洛多辛与术后早期不进行药物治疗对泌尿功能影响的随机对照试验

Early urinary catheter removal in patients undergoing rectal cancer surgery: a randomized controlled trial on silodosin versus no pharmacological treatment on urinary function in the early postoperative period.

作者信息

Gricius Žilvinas, Kuliavas Justas, Stratilatovas Eugenijus, Buckus Bronius, Dulskas Audrius

机构信息

Faculty of Medicine, Vilnius University, Vilnius, Lithuania.

Department of Surgical Oncology, National Cancer Institute, Vilnius, Lithuania.

出版信息

Ann Coloproctol. 2025 Jun;41(3):239-245. doi: 10.3393/ac.2024.00703.0100. Epub 2025 Jun 20.

Abstract

PURPOSE

This study aimed to evaluate the efficacy of the α1 adrenergic receptor antagonist silodosin in preventing lower urinary tract symptoms after rectal cancer surgery.

METHODS

We conducted a 2-arm, double-blind, single-center randomized controlled trial. The study included 150 patients with rectal cancer who underwent radical surgery between 2019 and 2022. On the first postoperative day, the urinary catheter was removed for all patients. Of these, 100 patients were administered silodosin, while 50 patients (control group) receive placebo (glucose tablet). Urinary dysfunction (urinary retention, infection, dysuria) and other complications were monitored.

RESULTS

Among the 150 patients, 84 (56.0%) were male and 66 (44.0%) were female. Surgical procedures included abdominoperineal resection in 33 patients, partial mesorectal excision in 45, and total mesorectal excision in 72. A laparoscopic approach was used in 69 patients, while the remaining 81 underwent open surgery. Urinary tract symptoms developed in 10 patients (6.7%): 7 (7.0%) in the silodosin group and 3 (6.0%) in the control group (P=0.92). In the silodosin group, there was 1 case (1.0%) of urinary retention, 3 cases (3.0%) of urinary tract infection, and 3 cases (3.0%) of dysuria. In the control group, there was 1 case (2.0%) each of urinary retention, urinary tract infection, and dysuria (all P=0.92).

CONCLUSION

Early urinary catheter removal on the first postoperative day was safe in both groups. The use of the oral α-antagonist silodosin did not provide additional benefits in preventing lower urinary tract symptoms in patients undergoing rectal cancer surgery. Trial registration: ClinicalTrials.gov identifier: NCT03607370.

摘要

目的

本研究旨在评估α1肾上腺素能受体拮抗剂西洛多辛预防直肠癌手术后下尿路症状的疗效。

方法

我们进行了一项双臂、双盲、单中心随机对照试验。该研究纳入了2019年至2022年间接受根治性手术的150例直肠癌患者。术后第一天,所有患者均拔除导尿管。其中,100例患者服用西洛多辛,50例患者(对照组)接受安慰剂(葡萄糖片)。监测排尿功能障碍(尿潴留、感染、排尿困难)及其他并发症。

结果

150例患者中,男性84例(56.0%),女性66例(44.0%)。手术方式包括腹会阴联合切除术33例、直肠系膜部分切除术45例、直肠系膜全切除术72例。69例患者采用腹腔镜手术,其余81例接受开放手术。10例患者(6.7%)出现尿路症状:西洛多辛组7例(7.0%),对照组3例(6.0%)(P = 0.92)。西洛多辛组有1例(1.0%)尿潴留、3例(3.0%)尿路感染、3例(3.0%)排尿困难。对照组有1例(2.0%)尿潴留、1例(2.0%)尿路感染、1例(2.0%)排尿困难(P均为0.92)。

结论

两组术后第一天早期拔除导尿管均安全。口服α拮抗剂西洛多辛在预防直肠癌手术患者下尿路症状方面未提供额外益处。试验注册号:ClinicalTrials.gov标识符:NCT03607370。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d0e/12215321/46248a18c515/ac-2024-00703-0100f1.jpg

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