Clinical trial NCT06769087: Comparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer
Postoperative Complication
Urinary Retention Postoperative
Enhanced Recovery After Surgery
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Eunpyeong St. Mary's Hospital, The Catholic University of Korea
name: Catholic University of Korea, Yeouido St. Mary's Hospital
name: The Catholic University of Korea Uijeongbu St.Marys Hostpial
name: Catholic University of Korea, St. Vincent Hospital
name: Incheon St.Mary's Hospital/The Catholic University
First posted: 2025-01-10
Enrollment: 316
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized controlled, non-inferior, multi-center trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Incidence of urinary drainage tube reinsertion rates
timeFrame: 7 days after surgery
measure: Incidence of symptomatic urinary tract infections (UTIs)
timeFrame: 30 days postoperatively
measure: postoperative pain scores
timeFrame: 3 days after surgery
measure: Postoperative narcotic analgesic use rate
timeFrame: 3 days after surgery
measure: early walking success rates
timeFrame: 3 days after surgery
measure: postoperative complications
timeFrame: 30 days after surgery
measure: Evaluation of patient symptom and quality of life
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's hospital, the Catholic university of Korea
Study officials:
References: