Comparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate urinary catheter removal, urinary catheter removal within postoperative 1day.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Postoperative Complication, Urinary Retention Postoperative, Enhanced Recovery After Surgery. Basic parameters: 19 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device Immediate urinary catheter removal
A urinary catheter is removed immediately after surgery and before general anesthesia wears off in the operating room. - 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).
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Seoul St.Mary's hospital, the Catholic university of Korea — Seoul
Identifiers
NCT: NCT06769087 · KC24EISI0519 · Seoul St.Mary's hospital