Martina Gabra, Christine Hall, Lelan McCann, Jeenal Shah, Ismael Jones, Aaron Masjedi, Stephanie Runke, Chiu-Hsieh Hsu, Andrea Aguirre
{"title":"坦索罗辛与子宫切除术后自然排气时间:随机对照试验。","authors":"Martina Gabra, Christine Hall, Lelan McCann, Jeenal Shah, Ismael Jones, Aaron Masjedi, Stephanie Runke, Chiu-Hsieh Hsu, Andrea Aguirre","doi":"10.1097/AOG.0000000000005724","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, NCT04859660.</p>","PeriodicalId":5,"journal":{"name":"ACS Applied Materials & Interfaces","volume":null,"pages":null},"PeriodicalIF":8.3000,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial.\",\"authors\":\"Martina Gabra, Christine Hall, Lelan McCann, Jeenal Shah, Ismael Jones, Aaron Masjedi, Stephanie Runke, Chiu-Hsieh Hsu, Andrea Aguirre\",\"doi\":\"10.1097/AOG.0000000000005724\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, NCT04859660.</p>\",\"PeriodicalId\":5,\"journal\":{\"name\":\"ACS Applied Materials & Interfaces\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":8.3000,\"publicationDate\":\"2024-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Materials & Interfaces\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/AOG.0000000000005724\",\"RegionNum\":2,\"RegionCategory\":\"材料科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MATERIALS SCIENCE, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Materials & Interfaces","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/AOG.0000000000005724","RegionNum":2,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MATERIALS SCIENCE, MULTIDISCIPLINARY","Score":null,"Total":0}
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.
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.