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

NCT06769087 | Enrolling By Invitation

• 2 other identifiers: KC24EISI0519Seoul St.Mary's hospital
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain

  \- 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

  3 days after surgery

Secondary Outcomes (7)

• Incidence of urinary drainage tube reinsertion rates

  7 days after surgery

• Incidence of symptomatic urinary tract infections (UTIs)

  30 days postoperatively

• postoperative pain scores

  3 days after surgery

• Postoperative narcotic analgesic use rate

  3 days after surgery

• early walking success rates

  3 days after surgery

Study Arms (2)

Immediate UC removal after surgery

EXPERIMENTAL

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

Device: Immediate urinary catheter removal

UC removal within 24hr after surgery

ACTIVE COMPARATOR

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

Device: urinary catheter removal within postoperative 1day

Interventions

Immediate urinary catheter removal DEVICE

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

Immediate UC removal after surgery

urinary catheter removal within postoperative 1day DEVICE

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

UC removal within 24hr after surgery

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Eunpyeong St. Mary's Hospital, The Catholic University of Korea: collaborator
• Catholic University of Korea, Yeouido St. Mary's Hospital: collaborator
• The Catholic University of Korea Uijeongbu St.Marys Hostpial: collaborator
• Saint Vincent's Hospital, Korea: collaborator
• Incheon St.Mary's Hospital/The Catholic University: collaborator

Study Sites (1)

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

Seoul, Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients, care provider and surgeons will be unaware of randomized assignment until the end of surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, randomized controlled, non-inferior, multi-center trial

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 10, 2025
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)