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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT03393234
Eligibility Criteria:
Inclusion Criteria:
* those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
* the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
* in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
* those in T4 stage and could be radically resected by intra-operative surgeon assessment;
* adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
* absence of distant metastases.
Exclusion Criteria:
* clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
* infiltrating gross appearance of the tumors;
* poorly differentiated adenocarcinoma by biopsy specimens;
* a degree of preoperative incontinence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03393234
Study Brief:
Protocol Section:
NCT03393234