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Enrolling by invitationNCT06769087POURUpdated Jul 9, 2026

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

An interventional study of Immediate urinary catheter removal and urinary catheter removal within postoperative 1day in Colorectal Cancer, Postoperative Complication and Urinary Retention Postoperative, sponsored by Seoul St. Mary's Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 282 studies in Colorectal Neoplasms with a site in Korea, Republic of — 60 open to participants now, 96 under way, 12 of them phase 3. Colorectal Neoplasms · Korea, Republic of.

Planned enrollment
74th of 250
316 · median 145
Started
2024
with 22 others
No phase
44 of 282
10 open now
Primary completion
2026-12
later than 34 of 95 live
Registered
252nd of 282
by date

Among the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of, this one is the 74th largest by planned enrollment of the 250 interventional ones that give a count, is one of 23 that started in 2024, is one of 44 with no phase, reaches primary completion later than 34 of the 95 other live ones, and was the 252nd registered.

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 316 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Open to participants now

60 of the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of are open now.

All 60 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 19 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 282 studies in Colorectal Neoplasms with a site in Korea, Republic of, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Colorectal Cancer
  • Postoperative Complication
  • Urinary Retention Postoperative
  • Enhanced Recovery After Surgery
04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
316 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceImmediate urinary catheter removal

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

  • Deviceurinary catheter removal within postoperative 1day

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 days after surgery

Secondary outcomes

  1. 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

    Time frame: 7 days after surgery

  2. Incidence of symptomatic urinary tract infections (UTIs)

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

    Time frame: 30 days postoperatively

  3. 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 .

    Time frame: 3 days after surgery

  4. Postoperative narcotic analgesic use rate

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

    Time frame: 3 days after surgery

  5. 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

    Time frame: 3 days after surgery

  6. 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.

    Time frame: 30 days after surgery

  7. 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.

    Time frame: 30 days after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.

Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 24 months is below that.

Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2024
First posted
Jan 10, 2025
StartActual
Dec 1, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06769087
Lead sponsor
Seoul St. Mary's Hospital
Responsible party
Yoon Suk Lee (Professor, Seoul St. Mary's Hospital) — Principal investigator
First posted
Jan 10, 2025
Start date
Dec 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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