Trials · 2019
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.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Xu Lai, Tao Zhi-Yan, Lu Jun-Yang, Zhang Guan-Nan, Qiu Hui-Zhong, Wu Bin, Lin Guo-Le, Xu Tao, Xiao Yi
Аннотация
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.
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.
Предметные рубрики MeSH
AdolescentAdultAgedBeijingCatheter-Related InfectionsCatheters, IndwellingDevice RemovalEquipment DesignEquivalence Trials as TopicFemaleHumansLaparoscopyMaleMiddle AgedProspective StudiesRectal NeoplasmsRectumTime FactorsTime-to-TreatmentTreatment OutcomeUrinary CatheterizationUrinary CathetersUrinary RetentionUrinary Tract InfectionsYoung Adult