Colorectal CancerPOURNCT06769087
Comparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery
A study testing Immediate urinary catheter removal and urinary catheter removal within postoperative 1day in people with Colorectal Cancer and Postoperative Complication, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Colorectal Cancer, Postoperative Complication, Urinary Retention Postoperative
- What is being tested?
- Immediate urinary catheter removal and urinary catheter removal within postoperative 1day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul St.Mary's hospital, the Catholic university of Korea
Seoul, Seoul, 06591
About this study
Official 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.
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.
Read the 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.
- Conditions
- Colorectal Cancer, Postoperative Complication, Urinary Retention Postoperative, Enhanced Recovery After Surgery
- Being tested
- Immediate urinary catheter removal, urinary catheter removal within postoperative 1day
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate urinary catheter removalDevice
A urinary catheter is removed immediately after surgery and before general anesthesia wears off in the operating room.
urinary catheter removal within postoperative 1dayDevice
The urethral catheter will be removed in the ward within 1 day after surgery (within 24 hours after surgery).
| Study group | Role | What they receive |
|---|---|---|
| Immediate UC removal after surgery | Experimental | A urinary catheter is removed immediately after surgery and before general anesthesia wears off, Receives: Device: Immediate urinary catheter removal |
| UC removal within 24hr after surgery | Active comparator | A urinary catheter is removed in the ward within postoperative 1 day (within 24 hours after surgery). Receives: Device: urinary catheter removal within postoperative 1day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days after surgery
Secondary outcomes (7)
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
Measured: 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
Measured: 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 .
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized controlled, non-inferior, multi-center trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon Suk Lee, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769087
- Sponsor's protocol ID
- KC24EISI0519
- Other IDs
- Seoul St.Mary's hospital
- Acronym
- POUR
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06769087
- Acronym / sponsor ID
- POUR / KC24EISI0519
- Conditions
- Colorectal Cancer, Postoperative Complication, Urinary Retention Postoperative, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- prospective, randomized controlled, non-inferior, multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Immediate UC removal after surgery | Experimental | Device: Immediate urinary catheter removalA urinary catheter is removed immediately after surgery and before general anesthesia wears off, |
| UC removal within 24hr after surgery | Active comparator | Device: urinary catheter removal within postoperative 1dayA urinary catheter is removed in the ward within postoperative 1 day (within 24 hours after surgery). |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate urinary catheter removalA urinary catheter is removed immediately after surgery and before general anesthesia wears off in the operating room. | Device | Immediate UC removal after surgery |
| urinary catheter removal within postoperative 1dayThe urethral catheter will be removed in the ward within 1 day after surgery (within 24 hours after surgery). | Device | UC removal within 24hr after surgery |
Primary outcome
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
7 secondary outcomes
Incidence of urinary drainage tube reinsertion rates
Time frame: 7 days after surgery
Incidence of symptomatic urinary tract infections (UTIs)
Time frame: 30 days postoperatively
postoperative pain scores
Time frame: 3 days after surgery
Postoperative narcotic analgesic use rate
Time frame: 3 days after surgery
early walking success rates
Time frame: 3 days after surgery
postoperative complications
Time frame: 30 days after surgery
Evaluation of patient symptom and quality of life
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate urinary catheter removal and urinary catheter removal within postoperative 1day in people with Colorectal Cancer and Postoperative Complication, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.