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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03574493
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
3. High risk operative patients (two of these factors as assessed on MRI):
1. Obese patient with a BMI \> 30 (male or female)
2. Narrow pelvis: inter-tuberous distance \< 10 cm
3. Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
4. Expected coloanal or ultra-low colorectal anastomosis
4. Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
5. Patient has signed and dated the informed consent before inclusion in the study.
Exclusion Criteria:
1. Patient with a comorbid illness or condition that would preclude the use of surgery.
2. Patients with T4b tumors which impose a pelvectomy
3. Patient requires an abdominal perineal resection (APR)
4. Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
5. Patient undergoing emergency procedures
6. Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
7. Metastatic disease
8. Pregnant or suspected pregnancy
9. Patients unwilling to comply with all follow-up study requirements
10. Patient included in another study which impact on the surgical technique or its choice.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03574493
Study Brief:
Protocol Section:
NCT03574493