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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07463261
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years;
* Primary rectal cancer staged as cT1-4aN0-3M0;
* Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;
* Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI);
* Planned radical minimally invasive surgery (laparoscopic or robotic-assisted procedure);
* Adequate hematologic function: hemoglobin ≥100 g/L, leukocytes \>4 × 10\^9/L, platelets \>100 × 10\^9/L;
* Adequate renal function: serum creatinine \<150 µmol/L;
* Adequate hepatic function: AST/ALT \<100 U/L;
* Predicted risk of anastomotic leakage ≤10% according to the study-specific risk model developed from retrospective data.
Exclusion Criteria:
* Age ≥70 years;
* Presence of a pre-existing diverting ileostomy or colostomy;
* Peritumoral abscess or tumor perforation;
* Distant metastases (M1) identified preoperatively and/or intraoperatively;
* Synchronous or metachronous malignancy;
* Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);
* Evidence of malnutrition (serum albumin \<34 g/L);
* Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive pulmonary disease, chronic kidney disease stage 4-5), type 1 or type 2 diabetes mellitus, or psychiatric/neurological disorders impairing the ability to provide informed consent;
* Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively;
* Predicted risk of anastomotic leakage \>10% according to the study risk model.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07463261
Study Brief:
Protocol Section:
NCT07463261