Seoul St.Mary's hospital, the Catholic university of Korea
Seoul, 06591, South Korea
NCT Number: NCT06769087
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.
Interested in participating?
Request Info19 year–80 year
All sexes
Interventional
Not applicable
Seoul, 06591, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A urinary catheter is removed immediately after surgery and before general anesthesia wears off in the operating room.
The urethral catheter will be removed in the ward within 1 day after surgery (within 24 hours after surgery).
Time frame: 3 days after surgery
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
Time frame: 30 days postoperatively
Bacterial identification rate of 10^5 CFU/mL or higher in urine culture test with clinical symptoms
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 .
Time frame: 3 days after surgery
Rates of narcotic analgesic use at 4±2 hours, 24±6 hours, and 48±6 hours postoperatively
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
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.
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.
Seoul St. Mary's Hospital
Other
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
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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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