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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01613651
Eligibility Criteria:
Inclusion Criteria:
* Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center
* Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
* Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria
Exclusion Criteria:
* Non-compliance
* Prior radiotherapy to the pelvis or prostate
* Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon
* Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
* Intra-operative injuries (for example: rectal injury)
* Inadequate hemostasis
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01613651
Study Brief:
Protocol Section:
NCT01613651