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

Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu, Yi Xiao, Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu, Yi Xiao

Abstract

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.

Keywords: Acute urinary retention; Laparoscopic anterior resection of the rectum; Removal time; Urinary catheter; Urinary tract infection.

Conflict of interest statement

Ethics approval and consent to participate

This trial protocol is approved by the Ethics Committee of Peking Union Medical College Hospital (reviewed in 2017 as ZS-1269) and has been registered at ClinicalTrials.gov under the identifier NCT03065855, registered on February 23, 2017. All eligible participants and their legal surrogates will be fully informed of the potential risks and benefits of the interventions in each group.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of enrollment, intervention, and assessment. IPSS International Prostate Symptom Score

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Source: PubMed

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