Duration of Urinary Catheterization
Duration of Urinary Catheterization
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. We 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. We 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).
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 (1). 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 (2). 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 (3).

 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:

 This study will be conducted as a prospective, randomized, non-inferiority trial. We will
 evaluate all patients undergoing total mesorectal excision for study eligibility. Consent for
 participation in the study will be obtained perioperatively. All male patients will be given
 a survey to assess their international prostate symptom severity (IPSS) score preoperatively.
 After surgery, the participant will be randomly assigned to the control (day 3 catheter
 removal) or experimental (day 1 catheter removal) group if there were no intraoperative
 complications deemed to interfere with the study, such as genitourinary tract injury
 requiring prolonged urinary catheterization postoperatively. Randomization will be performed
 using Microsoft Excel using a reported simple randomization method.(6) The control group will
 have catheter removed at 9AM on postoperative day 3, while the experimental arm will have
 catheter removed at 9AM on postoperative day 1. Participants will receive appropriate
 maintenance IV fluids depending on their ability to tolerate PO intake postoperatively.

 The primary endpoint of the study will be urinary retention, defined by grade 2 urinary
 retention per NCI CTCAE. Clinically, we will identify these patients as those unable to void
 within 6 hours of urinary catheter removal with associated signs of suprapubic fullness
 and/or tenderness, and bedside ultrasound bladder scan showing more than 250cc of urine.
 Bladder scan will only be performed on patients who have signs of urinary retention and are
 unable to void within 6 hours of catheter removal. If subjects are unable to void
 spontaneously within 6 hours following catheter removal, a one-time straight catheterization
 will be performed, as per standard practice. If subjects are still unable to urinate within 6
 hours following straight catheterization, an indwelling urinary catheter will be replaced.
 Secondary endpoints include urinary tract infection and length of hospital stay
 postoperatively. Urinary tract infection is defined as grade 2 or 3 urinary tract infection
 per NCI CTCAE. Patients will be evaluated for symptoms and signs of infection such as
 suprapubic pain, tenderness, dysuria, hematuria, and urinary frequency in addition to the
 presence of >100,000 colony-forming units/mL of bacteria on urine culture. Urinalysis and
 urine culture will only be sent in the setting of clinical signs and symptoms of urinary
 tract infection. Patients identified with UTI will be treated with pathogen-appropriate
 antibiotics as per standard practice. Length of hospital stay will be defined as the number
 of admitted days in the hospital from day of surgery to day of discharge. The participants
 will remain in the study until discharge from the hospital.

 Data Collection:

 Data regarding patient's demographic, past medical history, surgical indication, surgical
 approach, intraoperative complications, and postoperative outcomes including the mentioned
 endpoints will be collected prospectively through the electronic medical record system. The
 international prostate symptom severity (IPSS) score will be completed preoperatively for all
 male patients. Patient's medical record number will be numerically encoded and stored in a
 separate file. All paper documentation, including the original consent form, will be stored
 in a secure cabinet in the division office.

 Follow up:

 There will not be post-discharge follow up for the purpose of the research. Only data related
 to patient's history and inpatient hospital stay will be collected. Therefore, the follow up
 period for the endpoints is up to day of discharge.

 Sample Size and Accrual:

 Previous studies have identified rates of urinary retention following rectal surgery to
 approximately 20% (4, 5). Given no expected difference between the two groups, we therefore
 anticipate the urinary retention rate of both the study and control group to be 20%. Using a
 type I error of 5%, a power of 0.8, and a non-inferiority limit of 15% as reported by
 literature (3), a sample size of 88 per group will be needed. Given the anticipated rate of
 approximately 10 total mesorectal excision procedure per month, we anticipate needing 18
 months to fulfill the required sample size.

 Data Analyses Plans:

 The two randomized groups will be compared in terms of their preoperative demographics, prior
 history of benign prostatic hyperplasia, surgical indication, cancer staging, and neoadjuvant
 treatments. Intraoperative and postoperative factors will also be compared between the two
 groups. Subgroup analysis may be performed stratifying patients with different surgical
 indications and/or cancer staging. Given that the main research question involves patients
 following TME, regardless of surgical indication, the study may not be powered to observe
 differences when performing subgroup analyses.

 Comparisons between groups will be analyzed by the chi square test, the Mann Whitney U test,
 or the Student t test for quantitative and qualitative variables, as appropriate. The early
 catheter removal will be considered noninferior to standard removal if the upper limit of a
 1-sided 95% confidence interval excludes a difference in favor of the standard group of the
 standard group of more than 15%. A p-value of <.05 will be considered statistically
 significant.
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.