一项单中心、前瞻性、随机临床试验，旨在研究腹腔镜直肠前切除术后导尿管的最佳拔除时间：一项随机对照试验的研究方案
A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial.
作者信息
Xu Lai, Tao Zhi-Yan, Lu Jun-Yang, Zhang Guan-Nan, Qiu Hui-Zhong, Wu Bin, Lin Guo-Le, Xu Tao, Xiao Yi
机构信息
Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuai Fu Yuan, Dongcheng District, Beijing, 100730, People's Republic of China.
Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences/School of Basic Medicine, Peking Union Medical College, #5 Dongdan San Tiao, Beijing, 100005, People's Republic of China.
出版信息
Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.
BACKGROUND
Urinary catheter placement is essential before laparoscopic anterior resection for rectal cancer. Whether early removal of the catheter increases the incidence of urinary retention and urinary tract infection (UTI) is not clear. This study aims to determine the optimal time for removal of the urinary catheter after laparoscopic anterior resection of the rectum.
METHODS/DESIGN: A total of 220 participants meeting the inclusion criteria will be randomly assigned to an experimental group or a control group. The experimental group will have their urethral catheters removed on postoperative day 2 and the control group will have their urethral catheters removed on postoperative day 7. In both groups, catheter removal will be performed when the bladder is full. The incidence of urinary retention and UTI in the two groups will be compared to determine the optimal catheter removal time.
DISCUSSION
This is a prospective, single-center, randomized controlled trial to determine whether early removal of the urinary catheter after laparoscopic anterior resection of the rectum will help to decrease the incidence of postoperative acute urinary retention and UTI.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03065855 . Registered on 23 February 2017.
背景
在腹腔镜直肠癌前切除术之前放置导尿管至关重要。早期拔除导尿管是否会增加尿潴留和尿路感染（UTI）的发生率尚不清楚。本研究旨在确定腹腔镜直肠前切除术后拔除导尿管的最佳时间。
方法/设计：总共220名符合纳入标准的参与者将被随机分配到实验组或对照组。实验组将在术后第2天拔除尿道导尿管，对照组将在术后第7天拔除尿道导尿管。两组均在膀胱充盈时进行导尿管拔除。比较两组尿潴留和UTI的发生率，以确定最佳的导尿管拔除时间。
讨论
这是一项前瞻性、单中心、随机对照试验，旨在确定腹腔镜直肠前切除术后早期拔除导尿管是否有助于降低术后急性尿潴留和UTI的发生率。
试验注册
ClinicalTrials.gov，NCT03065855。于2017年2月23日注册。
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