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:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT04091620
Eligibility Criteria:
Inclusion Criteria:
* Consecutive patients who are diagnosed with mid or low rectal adenocarcinoma, of which the lowest margin of the tumor is located at or within 12 cm of the anal verge as determined by rigid sigmoidoscopy
* Those with clinically diagnosed cT1-3, N0-2, M0 disease based on preoperative staging with pelvic magnetic resonance imaging, computed tomography, and/or positron emission tomography
* Age of patients greater than or equal to 18 years
* Those with American Society of Anesthesiologists (ASA) grading I-III,
* Informed consent available
Exclusion Criteria:
* Patients with locally advanced cancer not amenable to curative surgery (e.g. involved mesorectal fascia on pelvic magnetic imaging despite neoadjuvant chemoradiotherapy)
* Those with locally advanced T4 cancer requiring en bloc multivisceral resection
* Those with very low rectal tumor requiring abdominoperineal resection
* Those with synchronous colorectal tumors requiring multisegment resection
* Those undergoing emergency surgery
* Those with previous history of abdominal surgery precluding the robotic or laparoscopic approach;
* Those with severe cardiopulmonary disease rendering pneumoperitoneum hazardous
* Those with psychiatric disease
* Those who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04091620
Study Brief:
Protocol Section:
NCT04091620