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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT04310800
Eligibility Criteria:
Inclusion Criteria:
* High transsphincteric fistula (involving \> 30% of the external anal sphincter)
* Age between 18 and 70 years
* Chronic anal fistula with fistula tracts no more than 2
* No active sepsis or abscess
Exclusion Criteria:
* Fistulas with active inflammation or purulence
* Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome
* Poorly controlled diabetes with fasting blood-glucose \> 8mmol/L
* Preexisting incontinence
* Multiple fistula tracts \> 2
* Fasting blood-glucose ≥ 8mmol/L
* Allergic or contraindication for the use of animal protein
* Pregnant women
* Expected life less than 6 months
* With anorectal abscess
* Serious liver (Child-Pugh C) and chronic kidney disease (CKD) stage 3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04310800
Study Brief:
Protocol Section:
NCT04310800