Optimal Duration of Urinary Catheterization After Total Mesorectal Excision
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 176
- Locations
- 2
- Primary Endpoint
- Rate of urinary retention
Study Overview
Brief Summary
This study is being conducted to determine the length of time a urinary catheter is needed to drain urine from the bladder after colorectal surgery. Urinary retention is a well known complication after pelvic colorectal surgery, and current practice is to continue urinary catheterization for 3- days following pelvic colorectal surgery in an effort to avoid this complication. However, prolonged urinary catheterization is associated with increased risk of urinary tract infections as well as longer hospital stays. The investigators hypothesize that postoperative urinary catheters may be safely removed on postoperative day 1 without increased urinary retention rates. The purpose of this study is to evaluate whether a shorter duration of urinary catheterization (1 day) is non-inferior when compared to standard duration (3 days) in regards to postoperative urinary retention. The investigators plan to perform a prospective, randomized, non-inferiority trial comparing the urinary catheter duration of 1 day and 3 days with the primary endpoint of postoperative urinary retention. Secondary endpoints are urinary tract infection and length of hospital stay. The participants will be randomly assigned to the control group (catheter removal on postoperative day 3) or the experimental group (catheter removal on postoperative day 1).
Detailed Description
Disease Background:
Total mesorectal excision can be associated with transient post-operative urinary retention due to surgical disruption of pelvic autonomic nerves during procedure. These patients receive intra-operative urinary catheter to prevent post-operative urinary retention. However, the optimal duration for post-operative urinary catheter is not known, and longer duration of urinary catheter is associated with increased morbidity, such as urinary tract infection. A previous prospective randomized controlled trial from 1999 looking at this subject showed an increased rate of postoperative urinary retention in patients who had shorter duration of urinary catheterization. However, surgical techniques have improved significantly since then and a newer retrospective study comparing outcomes between patients who had catheter removal on postoperative day 1 vs catheter removal on day 2 or later demonstrated lower rates of urinary retention overall and there was no difference in rates of urinary retention between the two groups. A recent randomized non--inferiority trial investigating early urinary catheter removal in patients undergoing major colorectal surgery found that early removal, when combined with an oral alpha- antagonist, is non--inferior to standard removal and is associated with lower rates of urinary tract infections and shorter hospital stays.
Rationale:
A current prospective randomized trial is needed to determine the optimal duration of urinary catheterization in patients who receive total mesorectal excision (TME). Urinary catheterization is an established part of the intraoperative and postoperative care for this surgery. There should be minimal urinary dysfunction as total mesorectal excision should preserve pelvic autonomic nerve function with careful dissection. Current standard of practice is removal of urinary catheter on postoperative day 3. The study participants would be exposed to minimal risk as they would already require urinary catheterization as part of the standard of care. While this study will determine duration of postoperative urinary catheterization, it will not impact the surgical procedure itself. The control group would undergo removal of urinary catheter on postoperative day 3 and the experimental group would undergo removal of urinary catheter on postoperative day 1. The main risk endured by study participants would be the need to replace the urinary catheter if the patient has urinary retention following catheter removal. This study will contribute to existing knowledge by providing a prospective randomized non--inferiority trial investigating the impact of duration of urinary catheterization following total mesorectal excision on rates of postoperative urinary retention, urinary tract infections, and length of hospital stay. If shorter duration of urinary catheterization is shown to be non--inferior to standard duration of catheterization in terms of postoperative urinary retention, adopting a practice of catheter removal on postoperative day 1 may result in lower rates of catheter--associated urinary tract infections and shorter hospital stays. This practice would also adhere to the Surgical Care Improvement Project (SCIP) measures which recommend removal of urinary catheter on postoperative day 1 or 2. We hypothesize that postoperative urinary catheters may be safely removed on postoperative day 1 following total mesorectal excision without increased urinary retention rates when compared to removal on postoperative day 3.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective procedures involving total mesorectal excision, including low anterior resection and abdominoperineal resection for rectal cancer as well as proctectomy for inflammatory bowel disease.
- •All approaches (open, laparoscopic and robotic) will be included, as the approaches not differ in the total mesorectal excision technique.
- •Patients who received neoadjuvant chemotherapy and/or radiation treatments will be included.
- •Age ≥ 18 years.
- •American Society of Anesthesiologists (ASA) class I-III.
- •Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- •Patients undergoing emergent or urgent surgery.
- •Patients undergoing total mesorectal excision in combination with other major surgical procedures on the same day should be excluded from this study.
- •Patients sustaining genitourinary tract injury during the procedure should be excluded postoperatively.
- •History of urinary retention after previous procedure, surgery, or urinary catheter removal.
- •History of urinary retention not being actively treated.
- •Patients requiring prolonged duration or replacement of urinary catheter in the postoperative period for reasons other than urinary retention should be excluded.
- •History of neurogenic bladder.
- •Patients with chronic indwelling Foley catheterization or suprapubic catheterization.
- •History of cystectomy and/or any surgically created urinary conduit, including neobladder and ileal conduit.
- •Patients less than 18 years of age should be excluded from this study.
- •Vulnerable patients including incarcerated patients or any patients unable or unwilling to provide informed consent will be excluded from this study.
Arms & Interventions
Urinary catheter removal on postoperative day 1
Intervention: Urinary catheter removal on postoperative day 1 (Other)
Urinary catheter removal on postoperative day 3
Intervention: Urinary catheter removal on postoperative day 3 (Other)
Outcomes
Primary Outcomes
Rate of urinary retention
Time Frame: From time of surgery to time of discharge from the hospital, an average of 4 days
Secondary Outcomes
- Rate of urinary tract infection(From time of surgery to time of discharge from the hospital, an average of 4 days)
- Length of hospital stay(From time of surgery to time of discharge from the hospital, an average of 4 days)
Investigators
Sarah Koller
Assistant Professor of Clinical Surgery
University of Southern California