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

NCT ID: NCT06769087

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-31

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.

Conditions

Colorectal Cancer; Postoperative Complication; Urinary Retention Postoperative; Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Immediate UC removal after surgery

A urinary catheter is removed immediately after surgery and before general anesthesia wears off,

Group Type: EXPERIMENTAL

Immediate urinary catheter removal

Intervention Type: DEVICE

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

UC removal within 24hr after surgery

A urinary catheter is removed in the ward within postoperative 1 day (within 24 hours after surgery).

Group Type: ACTIVE_COMPARATOR

urinary catheter removal within postoperative 1day

Intervention Type: DEVICE

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

Interventions

Immediate urinary catheter removal

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

Intervention Type: 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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunpyeong St. Mary's Hospital, The Catholic University of Korea

UNKNOWN

Sponsor Role: collaborator

Catholic University of Korea, Yeouido St. Mary's Hospital

UNKNOWN

Sponsor Role: collaborator

The Catholic University of Korea Uijeongbu St.Marys Hostpial

UNKNOWN

Sponsor Role: collaborator

Catholic University of Korea, St. Vincent Hospital

UNKNOWN

Sponsor Role: collaborator

Incheon St.Mary's Hospital/The Catholic University

UNKNOWN

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yoon Suk Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul St.Mary's hospital, the Catholic university of Korea

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

Seoul St.Mary's hospital

Identifier Type: OTHER

Identifier Source: secondary_id

KC24EISI0519

Identifier Type: -

Identifier Source: org_study_id