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Enrolling by Invitation

NCT Number: NCT06769087

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate urinary catheter removal

Device

A urinary catheter is removed immediately after surgery and before general anesthesia wears off in the operating room.

urinary catheter removal within postoperative 1day

Device

The urethral catheter will be removed in the ward within 1 day after surgery (within 24 hours after surgery).

Primary outcomes

  1. Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain

    Time frame: 3 days after surgery

    • 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

Secondary outcomes

  1. Incidence of urinary drainage tube reinsertion rates

    Time frame: 7 days after surgery

    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

  2. Incidence of symptomatic urinary tract infections (UTIs)

    Time frame: 30 days postoperatively

    Bacterial identification rate of 10^5 CFU/mL or higher in urine culture test with clinical symptoms

  3. postoperative pain scores

    Time frame: 3 days after surgery

    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 .

  4. Postoperative narcotic analgesic use rate

    Time frame: 3 days after surgery

    Rates of narcotic analgesic use at 4±2 hours, 24±6 hours, and 48±6 hours postoperatively

  5. early walking success rates

    Time frame: 3 days after surgery

    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

  6. postoperative complications

    Time frame: 30 days after surgery

    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.

  7. Evaluation of patient symptom and quality of life

    Time frame: 30 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study title

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.

Acronym: POUR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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