预防性艾灸预防痔切除术后尿潴留：一项随机对照试验的研究方案
Prophylactic Moxibustion in Preventing Postoperative Urinary Retention of Hemorrhoidectomy: A Study Protocol for a Randomized Controlled Trial.
作者信息
Ji Lijiang, Wang Aihua, Fan Qian, Zhang Naijin, Weng Liping, Gu Jing
机构信息
Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, China.
Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
出版信息
Front Surg. 2022 Jul 5;9:898097. doi: 10.3389/fsurg.2022.898097. eCollection 2022.
BACKGROUNDS
Postoperative urinary retention (POUR) is one of the most common complications after hemorrhoidectomy. The best treatment for POUR is prevention and should be involved in the whole perioperative period. Moxibustion has been used to treat urinary retention for thousands of years, and clinical studies have also proved its effects. We try to carry out a randomized, controlled, prospective study to observe whether prophylactic moxibustion could effectively reduce the incidence of POUR of hemorrhoidectomy in 24 h.
METHODS
This study is a single-center, evaluator-blinded, randomized, and controlled trial. Participants who meet the inclusion and exclusion criteria in this RCT will be randomly assigned to either the treatment group (moxibustion) or the control group (tamsulosin hydrochloride) in a 1:1 ratio according to a computer-generated randomization list. Both moxibustion and tamsulosin will be used 1, 10, and 24 h after operation, respectively. The outcomes of occurrence of POUR, time to first urination, catheterization rate, urinary tract infection, length of hospitalization, and adverse effects will be recorded.
DISCUSSION
The findings of the study will help to explore the preventive efficacy of prophylactic moxibustion against POUR of hemorrhoidectomy in 24 h.
TRIAL REGISTRATION
CHiCTR, CHiCTR2000039350, registered 24 October, 2020, http://www.chictr.org.cn/showproj.aspx?proj = 63204.
背景
术后尿潴留（POUR）是痔切除术后最常见的并发症之一。POUR的最佳治疗方法是预防，且应贯穿于整个围手术期。艾灸治疗尿潴留已有数千年历史，临床研究也证实了其疗效。我们试图开展一项随机、对照、前瞻性研究，以观察预防性艾灸能否有效降低痔切除术后24小时内POUR的发生率。
方法
本研究为单中心、评估者盲法、随机对照试验。符合本随机对照试验纳入和排除标准的参与者将根据计算机生成的随机列表按1:1的比例随机分配至治疗组（艾灸）或对照组（盐酸坦索罗辛）。艾灸和盐酸坦索罗辛分别在术后1小时、10小时和24小时使用。记录POUR的发生情况、首次排尿时间、导尿率、尿路感染、住院时间和不良反应等结果。
讨论
本研究结果将有助于探索预防性艾灸对痔切除术后24小时内POUR的预防效果。
试验注册
中国临床试验注册中心，注册号：CHiCTR2000039350，注册时间：2020年10月24日，网址：http://www.chictr.org.cn/showproj.aspx?proj = 63204 。
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