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:
NCT07146334
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Patients with rectal cancer lower than 12 cm from the anal verge requiring either a stapling anastomosis below 7 cm from the anal verge,
* Patients with powered mechanical anastomosis (INTOCARE devices)
* Patients with no metastasis
* Patients operated on by mini-invasive rectal excision (laparoscopic, robotic or TaTME);
* Patients with or without defunctioning ileostomy;
* Patients with or without neoadjuvant treatment;
* Patient who benefits by medicare system;
* Signed and dated informed consent
Exclusion Criteria:
* Patients with handsewn anastomosis
* Patients with perforated rectal cancer or preoperative pelvic sepsis ;
* Patients with inflammatory bowel disease;
* Patients operated on in emergency ;
* Patients with extended-TME or pelvic exenteration;
* Pregnancy or breast feeding period
* Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
* Persons deprived of liberty or under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07146334
Study Brief:
Protocol Section:
NCT07146334