Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT04359069
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04359069
Study Brief:
Protocol Section:
NCT04359069