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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT02311803
Eligibility Criteria:
Inclusion Criteria:
1. Age from over 20 to under 60 years;
2. Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
3. Mid-low rectal cancer (distance from anal edge≤12cm);
4. cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
5. Expected curative resection through L-PANP;
6. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
7. ASA (American Society of Anesthesiology) score class I, II, or III;
8. Written informed consent;
9. Urinary and sexual function normal preoperatively
Exclusion Criteria:
1. Severe mental disorder;
2. History of previous pelvic surgery;
3. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
4. History of other malignant disease within past five years;
5. History of unstable angina or myocardial infarction within past six months;
6. History of cerebrovascular accident within past six months;
7. History of continuous systematic administration of corticosteroids within one month;
8. Contraindication of heart, brain, lung, etc dysfunction;
9. Requirement of simultaneous surgery for other disease;
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
11. Rectal cancer invades surrounding tissues;
12. Existence of genuine incontinence or severe stress incontinence preoperatively
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT02311803
Study Brief:
Protocol Section:
NCT02311803