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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT06567756
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-75 years;
2. Pathologically confirmed: moderately \& well-differentiated rectal cancer;
3. Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
4. Tumor diameter: ≤3cm or \<1/3 bowel circumference;
5. Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
6. Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
7. ASA score: I-III and ECOG score: 0-1;
8. Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
9. Normal preoperative anal function: Wexner score \<10, LARS score \<20;
10. Agree to participate in the clinical trial and sign an informed consent form.
Exclusion Criteria:
1. Combination of synchronous or metachronous (within 5 years) malignant tumors;
2. Combined distant metastasis of the tumor;
3. Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
4. Combined psychiatric disorders that do not allow them to understand and participate in the study;
5. Combined systemic diseases that cannot tolerate surgery;
6. Women who are pregnant or breastfeeding;
7. Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06567756
Study Brief:
Protocol Section:
NCT06567756