Colorectal Cancer, Enhanced Recovery After Surgery, Postoperative Complication, Urinary Retention Postoperative
Conditions
Brief 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.
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
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).
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients, care provider and surgeons will be unaware of randomized assignment until the end of surgery.
Intervention model description
prospective, randomized controlled, non-inferior, multi-center trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urinary drainage tube reinsertion rates | 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 |
| Incidence of symptomatic urinary tract infections (UTIs) | 30 days postoperatively | Bacterial identification rate of 10\^5 CFU/mL or higher in urine culture test with clinical symptoms |
| postoperative pain scores | 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 . |
| Postoperative narcotic analgesic use rate | 3 days after surgery | Rates of narcotic analgesic use at 4±2 hours, 24±6 hours, and 48±6 hours postoperatively |
| early walking success rates | 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 |
| postoperative complications | 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. |
| Evaluation of patient symptom and quality of life | 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. |
Countries
South Korea
Outcome results
None listed