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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00971269
Eligibility Criteria:
Inclusion Criteria:
1. Fecal incontinence with at least 2 episodes/week
2. Symptom duration at least one year
3. Failed attempt of conservative therapy
4. Age 18-80
5. Written informed consent
6. Available for follow-up
7. Fully compliant with protocol
Exclusion Criteria:
1. Active inflammatory bowel disease
2. Total external sphincter defect at ultrasound and clinical examination
3. Bleeding diathesis or anticoagulant therapy
4. Rectal prolapse or intussusceptions
5. Present anal sepsis
6. Anorectal implants
7. Recent anorectal surgery (within 6 months)
8. Rectal anastomosis
9. Pregnancy, postpartum (one year) or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00971269
Study Brief:
Protocol Section:
NCT00971269