坦索罗辛与子宫切除术后自然排气时间:随机对照试验。

IF 8.3 2区 材料科学 Q1 MATERIALS SCIENCE, MULTIDISCIPLINARY ACS Applied Materials & Interfaces Pub Date : 2024-09-12 DOI:10.1097/AOG.0000000000005724
Martina Gabra, Christine Hall, Lelan McCann, Jeenal Shah, Ismael Jones, Aaron Masjedi, Stephanie Runke, Chiu-Hsieh Hsu, Andrea Aguirre
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引用次数: 0

摘要

目的评估术前单次服用坦索罗辛是否能缩短微创子宫切除术患者的术后排空时间和出院时间:这项单中心、整群随机、安慰剂对照、双盲优效试验评估了 0.4 毫克坦索罗辛与安慰剂相比对子宫切除术后排空时间的影响。接受门诊微创子宫切除术的患者在术前 1 小时随机接受单剂量坦索罗辛或安慰剂治疗。所有参与者都接受了标准化的后填排尿试验,以消除膀胱容量差异对排尿时间的影响。对于我们的主要目标,我们计划招募 150 名参与者,以显示术后排尿时间缩短了 30 分钟(80% 功率,α 结果:从 2021 年 6 月到 2023 年 1 月,共筛选出 344 名患者,其中 150 人被纳入最终数据分析:坦索罗辛组 77 人,安慰剂组 73 人。坦索罗辛组和安慰剂组的自主排尿时间没有差异(106 分钟 vs 100 分钟,P=.5)。此外,从麻醉后护理病房出院的时间也没有统计学差异(144 分钟 vs 156 分钟,P=.4)。各组的人口统计学和手术细节没有差异:结论:术前服用单剂量坦索罗辛不会导致因良性疾病接受微创子宫切除术的患者术后排空时间或出院时间缩短:临床试验注册:ClinicalTrials.gov,NCT04859660。
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Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial.

Objective: To evaluate whether a single preoperative dose of tamsulosin reduces the time to postoperative void and time to discharge in patients who are undergoing minimally invasive hysterectomy.

Methods: This single-center, block-randomized, placebo-controlled, double-blind superiority trial evaluated the effect of 0.4 mg tamsulosin compared with placebo on the time to void after hysterectomy. Patients who underwent outpatient minimally invasive hysterectomy were randomized to a single dose of tamsulosin or placebo 1 hour before surgery. All participants underwent a standardized backfill void trial to eliminate discrepancies in bladder volume that would otherwise affect the time to void. For our primary aim, we planned to enroll 150 participants to show a 30-minute reduction in the time to postoperative void (80% power, α<0.05). The secondary aim was to compare the time to discharge from the postanesthesia care unit.

Results: From June 2021 through January 2023, 344 patients were screened, and 150 were included in the final data analysis: 77 in the tamsulosin group and 73 in the placebo group. The time to spontaneous void was not different between the tamsulosin and placebo groups (106 minutes vs 100 minutes, P=.5). In addition, there was no statistical difference in time to discharge from the postanesthesia care unit (144 minutes vs 156 minutes, P=.4). Demographics and surgical details were not different between each group.

Conclusion: A single dose of tamsulosin preoperatively does not lead to a decrease in postoperative time to void or time to discharge in patients undergoing minimally invasive hysterectomy for benign conditions.

Clinical trial registration: ClinicalTrials.gov, NCT04859660.

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来源期刊
ACS Applied Materials & Interfaces
ACS Applied Materials & Interfaces 工程技术-材料科学:综合
CiteScore
16.00
自引率
6.30%
发文量
4978
审稿时长
1.8 months
期刊介绍: ACS Applied Materials & Interfaces is a leading interdisciplinary journal that brings together chemists, engineers, physicists, and biologists to explore the development and utilization of newly-discovered materials and interfacial processes for specific applications. Our journal has experienced remarkable growth since its establishment in 2009, both in terms of the number of articles published and the impact of the research showcased. We are proud to foster a truly global community, with the majority of published articles originating from outside the United States, reflecting the rapid growth of applied research worldwide.
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