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 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT04637061
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older.
* Rectal adenocarcinoma or benign polyp with indication for rectal resection with total or partial mesorectal excision and primary colo-rectal anastomosis with/or without protective ostomy.
* Patients undergoing upfront surgery and patients undergoing neoadjuvant therapy followed by surgery.
* Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2).
* Patient must sign the Informed Consent Form (ICF) before any study procedures and agrees to attend all study visits.
* Selection of the patient before inclusion.
Exclusion Criteria:
* • Patient pregnant or suspected pregnancy.
* Patient with a comorbid illness or condition that would preclude the use of surgery.
* Past medical history of Inflammatory Bowel Disease (IBD).
* Synchronous cancers requiring extended sub-total or total colectomies.
* Long lasting therapy with steroids to be continued in the peri-operative period (4 weeks previous and 4 weeks after surgery).
* Use of antiplatelet drug (anti-aggregant) and/or oral anti-coagulant drug to be continued in the peri-operative period (1 week previous and 4 weeks after surgery).
* Patients assessed as American Society of Anesthesiologists (ASA) physical status 4.
* Patients with clinical stage of cT4b tumor after neoadjuvant theapy.
* Metastatic disease (clinical Stage 4).
* Patient undergoing emergency procedures.
* Planned colonic surgery along with major concomitant procedures (i.e. liver resections, other intestinal resections).
* Previous colon surgery (excluding appendectomy).
* Non-restorative procedures (i.e. Miles or Hartman resection).
* Colo-anal manual anastomosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04637061
Study Brief:
Protocol Section:
NCT04637061