Urinary Tract Infection (UTI) Clinical Trials

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Optimal Duration of Urinary Catheterization After Total Mesorectal Excision

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Keck Hospital of USC
RECRUITING
Los Angeles
Los Angeles County Hospital (LAC/USC)
RECRUITING
Los Angeles
Contact Information
Primary
Sarah Koller, MD
sarah.koller@med.usc.edu
(323) 865-3690
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2029-01
Participants
Target number of participants: 176
Treatments
Experimental: Urinary catheter removal on postoperative day 1
Active_comparator: Urinary catheter removal on postoperative day 3
Related Therapeutic Areas
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov