RecruitingNot Applicable

Duration of Urinary Catheterization

United States176 participantsStarted 2020-10-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Rate of urinary retention

Timeframe: From time of surgery to time of discharge from the hospital, an average of 4 days

Trial details

NCT IDNCT04359069

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Sarah Koller, MD

(323) 865-3690 sarah.koller@med.usc.edu