Comparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery (POUR)

Comparative Analysis of Clinical and Patient-Reported Outcomes: Immediate Versus Postoperative Day 1 Removal of Urinary Catheter After Colorectal Cancer Surgery in a Non-inferiority, Randomized Controlled Trial.

The enhanced recovery after surgery (ERAS) program is widely applied in colorectal cancer surgery. Among the early recovery programs after surgery, the timing of removal of the urinary catheter after surgery has been emphasized recently, but the specific timing is still under discussion. Maintaining the urinary catheter after surgery is to prevent urinary retention after surgery, but it is known that the risk of urinary tract infection increases the longer it is maintained. Previously, it was removed 3 days after colorectal cancer surgery, but several studies reported that even if it was removed earlier, the incidence of urinary retention did not increase, and rather the incidence of urinary tract infection decreased. In particular, by applying the early recovery program after surgery, factors related to patient recovery before, during, and after surgery are applied to help rapid recovery, and it has been reported that early removal of the urinary catheter has a positive effect on postoperative recovery and complications. Therefore, it is necessary to prove that the timing of removal of the urinary catheter after surgery in colorectal cancer patients can help early recovery through clinical results such as patient recovery and occurrence of complications.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer; Postoperative Complication; Enhanced Recovery After Surgery; Urinary Retention Postoperative
• Intervention / Treatment: Device: Immediate urinary catheter removal; Device: urinary catheter removal within postoperative 1day

Detailed Description

This study aims to demonstrate that removing the urinary drain immediately after colorectal cancer surgery is non-inferior to removing it on the first day (within 24 hours) after surgery in terms of the incidence of acute urinary retention.

To evaluate the non-inferiority of the incidence of acute urinary retention (AUR) according to the timing of urinary drain removal after surgery.

Secondary outcomes are the incidence of symptomatic urinary tract infection (UTI), postvoid residual (PVR), length of hospital stay, postoperative pain score, and narcotic analgesic usage, early ambulation success rate, postoperative complication rate, and overactive bladder symptom assessment score for patient discomfort, etc., and to compare the clinical outcomes after surgery from various perspectives.

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Seoul St.Mary's hospital, the Catholic university of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 19 years old 80 years old
• Patients diagnosed with colorectal cancer who are eligible for radical resection surgery
• Patients who underwent open, laparoscopic, or robotic surgery
• Written informed consent

Exclusion Criteria:

• Patients who have undergone two or more major abdominal surgeries, including lateral pelvic lymph node dissection, at the same time
• Patients who require continuous monitoring through a urinary catheter due to hemodynamic instability or massive bleeding, etc.
• Patients who have undergone conventional treatment in cases other than distant metastasis or R0 resection
• Patients who have developed complications related to the urinary system during surgery and require maintenance of a urinary catheter such as a urethral stent
• Patients who have undergone urinary surgery such as urethral stent placement, cystectomy, or urostomy in the past
• Patients who are on hemodialysis or peritoneal dialysis due to chronic renal failure
• Patients who cannot participate in a clinical trial at the discretion of a physician
• Patients who do not wish to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate UC removal after surgery; A urinary catheter is removed immediately after surgery and before general anesthesia wears off,	Device: Immediate urinary catheter removal; A urinary catheter is removed immediately after surgery and before general anesthesia wears off in the operating room.
Active Comparator: UC removal within 24hr after surgery; A urinary catheter is removed in the ward within postoperative 1 day (within 24 hours after surgery).	Device: urinary catheter removal within postoperative 1day; The urethral catheter will be removed in the ward within 1 day after surgery (within 24 hours after surgery).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain	- Definition of acute urinary retention: Failure to urinate spontaneously within 4 hours after removal of the urinary drainage tube or occurrence of residual volume greater than 400 ml as measured by ultrasound	3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urinary drainage tube reinsertion rates	The rate of re-insertion of a urinary catheter due to failure of self-voiding at 4 hours after surgery and re-evaluation 4 hours later according to the protocol	7 days after surgery
Incidence of symptomatic urinary tract infections (UTIs)	Bacterial identification rate of 10^5 CFU/mL or higher in urine culture test with clinical symptoms	30 days postoperatively
postoperative pain scores	Visual analog scale (VAS) score at 4±2 hours, 24±6 hours, and 48±6 hours after surgery. The NRS is a single-item scale in which patients choose a number from 0 to 10 that best represents their pain intensity, with 0 indicating no pain, 1 to 3 indicating mild pain, 4 to 6 indicating moderate pain, and 7 to 10 indicating severe pain .	3 days after surgery
Postoperative narcotic analgesic use rate	Rates of narcotic analgesic use at 4±2 hours, 24±6 hours, and 48±6 hours postoperatively	3 days after surgery
early walking success rates	Success rate of walking for more than 15 minutes three times a day at 4±2 hours, 24±6 hours, and 48±6 hours after surgery	3 days after surgery
postoperative complications	Charlson comorbidity index (CCI) score within 1 month of discharge from surgery. The CCI is based on the Clavien system but accounts for all accumulated complications and provides a continuous overall score between 0-100. The higher the score, the worse it is.	30 days after surgery
Evaluation of patient symptom and quality of life	Comparison of overactive bladder symptom assessment scores. Patient evaluation is performed using the Overactive Bladder Questionnaire (OAB-q short form) questionnaire. It consists of 19 items, each item is evaluated from 1 to 6 points, and the total score is 114 points. A higher score indicates more discomfort from overactive bladder.	30 days after surgery

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: Eunpyeong St. Mary's Hospital, The Catholic University of Korea; Catholic University of Korea, Yeouido St. Mary's Hospital; Incheon St.Mary's Hospital/The Catholic University; Catholic University of Korea, St. Vincent Hospital; The Catholic University of Korea Uijeongbu St.Marys Hostpial

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Urination Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Postoperative Complications; Urinary Retention
• Other Study ID Numbers: KC24EISI0519; Seoul St.Mary's hospital (Other Identifier: Seoul St.Mary's hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No