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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02336867
Eligibility Criteria:
Inclusion Criteria:
* Complex anal fistula (intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric) drained and requiring closing intervention of fistula.
* Obtaining the patient's written consent
* Naive patient to any surgical treatment for fistula closure
* Patient receiving a social security scheme
Exclusion Criteria:
* \<18 years and\> 80 years
* BMI\> 35 kg / m²
* Rectovaginal or rectourethral fistulas
* Infections : sepsis, tuberculosis or HIV
* History of allergy to nickel
* Cognitive disorders or major disability making it impossible to understand the study and signed an informed consent
* Already included in another clinical trial patients
* breastfeeding or pregnancy
* Legal incapacity (person deprived of liberty or guardianship)
* Patients not compliant with the criteria of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02336867
Study Brief:
Protocol Section:
NCT02336867