RECRUITING

Duration of Urinary Catheterization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Optimal Duration of Urinary Catheterization After Total Mesorectal Excision

Quick Facts

Study Start:2020-10-01

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04359069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Sarah Koller, MD

CONTACT

(323) 865-3690

sarah.koller@med.usc.edu

Study Locations (Sites)

Keck Hospital of USC

Los Angeles, California, 90033

United States

Los Angeles County Hospital (LAC/USC)

Los Angeles, California, 90033

United States

Collaborators and Investigators

Sponsor: University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01

Study Completion Date2024-12

Study Record Updates

Study Start Date2020-10-01

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Surgery