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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT04078828
Eligibility Criteria:
Inclusion Criteria:
1. patients with histologically proven rectal adenocarcinoma
2. tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
3. Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
4. Negative circumferential resection margin confirmed by MRI
5. Performance status (ECOG) 0\~1
6. Written informed consent for participation in the trial
Exclusion Criteria:
1. History of accepting lower abdominal surgery.
2. More than one colorectal tumor
3. Patients with unresectable distant metastasis or multiple metastases
4. Received neoadjuvant radiotherapy before surgery
5. Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
6. Patients and/or family members cannot understand and accept this study
7. Non-rectal adenocarcinoma was confirmed by postoperative pathological examination
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04078828
Study Brief:
Protocol Section:
NCT04078828