TEMPOUR: A Randomized Controlled Trial Assessing Perioperative Use of An Alpha-1-Blocker to Reduce Postoperative Urinary Retention Following Transanal Endoscopic Microsurgery Procedures.

IF 3.2 2区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Thomas Couture, Claudya Morin, Janyssa Charbonneau, Émilie Papillon-Dion, Alexandre Bouchard, François Rouleau-Fournier, Philippe Bouchard, François Letarte, Alexis F Turgeon
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引用次数: 0

Abstract

Background: Transanal endoscopic microsurgery is a treatment option for a wide range of rectal lesions. Postoperative urinary retention is a frequently associated complication. Some studies have suggested that the use of alpha-1-blockers may reduce the risk of postoperative urinary retention after hernia and colorectal surgery, but evidence is lacking.

Objective: This trial aims to evaluate if prophylactic use of an alpha-1-blocker reduces the rate of postoperative urinary retention following transanal endoscopic microsurgery.

Design: Double-blind, placebo-controlled trial.

Settings: Single high-volume Canadian colorectal center.

Patients: Adult male patients awaiting transanal endoscopic microsurgery and not on alpha-1-blocker were included.

Intervention: Patients were allocated to either Tamsulosin or placebo from 5 days prior to surgery to 2 days postoperatively.

Main outcomes measures: The primary outcome was the incidence of post-operative urinary retention. Secondary outcomes were urinary retention-related hospitalization, time to removal of bladder catheter and International Prostate Symptom Score, before and after treatment, and adverse events.

Results: 158 patients were randomized between October 2017 and July 2022. There was no significant difference in postoperative urinary retention between groups (23% vs 14%; p = 0.16) respectively in the tamsolusin and placebo groups. Time to removal of bladder catheter was not statistically different between groups (4.8 vs 8.6 days, p = 0.26). No failure of same-day discharge, nor readmissions related to urinary retention occurred. International Prostate Symptom Scores were not significantly different at the time of surgery (3.8 vs 5.4; p = 0.11) and reported adverse events did not differ between groups.

Limitations: We cannot exclude a potential type II error.

Conclusion: Prophylactic use of an alpha-1-blocker for patients undergoing transanal endoscopic microsurgery was not associated with a reduction in post-operative urinary retention. See Video Abstract.

Trial registration: ClinicalTrials.gov Identifier: NCT03314025.

TEMPOUR:一项随机对照试验评估围手术期使用α -1阻滞剂减少经肛门内窥镜显微手术后尿潴留。
背景:经肛门内窥镜显微手术是广泛的直肠病变的治疗选择。术后尿潴留是常见的并发症。一些研究表明,使用α -1受体阻滞剂可以降低疝和结直肠手术后尿潴留的风险,但缺乏证据。目的:本试验旨在评估预防性使用α -1受体阻滞剂是否能降低经肛门内镜显微手术后尿潴留的发生率。设计:双盲、安慰剂对照试验。设置:单个高容量的加拿大结直肠癌中心。患者:包括等待经肛门内窥镜显微手术且未使用α -1受体阻滞剂的成年男性患者。干预:从术前5天到术后2天,患者被分配到坦索罗辛或安慰剂组。主要观察指标:主要观察指标为术后尿潴留发生率。次要结局为尿潴留相关住院、拔除膀胱导管时间、国际前列腺症状评分、治疗前后以及不良事件。结果:158例患者在2017年10月至2022年7月期间被随机分组。两组术后尿潴留无显著差异(23% vs 14%;P = 0.16)。两组患者拔除膀胱导管的时间差异无统计学意义(4.8天vs 8.6天,p = 0.26)。无当日出院失败,无尿潴留相关再入院。国际前列腺症状评分在手术时无显著差异(3.8 vs 5.4;P = 0.11),报告的不良事件组间无差异。局限性:我们不能排除潜在的II型错误。结论:经肛门内镜显微手术患者预防性使用α -1阻滞剂与术后尿潴留的减少无关。参见视频摘要。试验注册:ClinicalTrials.gov标识符:NCT03314025。
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来源期刊
CiteScore
4.50
自引率
7.70%
发文量
572
审稿时长
3-8 weeks
期刊介绍: Diseases of the Colon & Rectum (DCR) is the official journal of the American Society of Colon and Rectal Surgeons (ASCRS) dedicated to advancing the knowledge of intestinal disorders by providing a forum for communication amongst their members. The journal features timely editorials, original contributions and technical notes.
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