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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT06569966
Eligibility Criteria:
Inclusion Criteria:
* aged 18-85 years old
* Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
* rectal cancer confirmed by preoperative pathology
* in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
* prophylactic ileostomy.
Exclusion Criteria:
* cannot complete treatment
* the history of the anorectal surgery
* preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
* postoperative anastomotic fistula and stricture
* during pregnancy or breastfeeding women
* with uncontrolled seizures, central nervous system disease or a history of mental disorders
* the last five years have other history of malignant disease cured except skin cancer and cervical carcinoma in situ
* clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association class II or worse 9) severe congestive heart failure or major arrhythmia requiring medical intervention, or myocardial infarction within the previous 6 months
* has a history of cerebral infarction or cerebral hemorrhage within the past 6 months
* organ transplantation requiring immunosuppressive therapy
* serious uncontrolled repeated infections, or other serious with disease of control;
* moderate or severe renal impairment creatinine clearance equal to or less than 50ml/min, or upper limit of normal (ULN)
* emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
* in screening the first 4 weeks received study medication or treatment (to participate in other test).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06569966
Study Brief:
Protocol Section:
NCT06569966