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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT03819257
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 and ≤ 75 year-old patients
2. CD in clinical remission, defined by a Harvey-Bradshaw index \<5
3. Perianal CD history, defined by the presence of a perianal fistula and/or abscess that were treated/heal/inactive
4. Perianal Disease Activity Index (PDAI) of ≤4
5. Asymptomatic or symptomatic patients (anorectal symptoms) will be included, as long they fulfill the other inclusion criteria, like for anorectal symptomatic patients having a PDAI≤4
6. Endoanal ultrasound without an image compatible with new/non-treated abscess or perianal fistula
7. Both previous simple or complex perianal fistula (according to the American College of Gastroenterology) will be considered.
Exclusion Criteria:
1. Women with previous vaginal delivery
2. Ileostomy
3. Previous anorectal surgery as hemorrhoidectomy or lateral sphincterotomy
4. Active rectal disease. No rectal involvement will be defined by no previous rectal involvement ever described or if previous involvement, endoscopy within 18 months showing no current involvement
5. Previous or current anal fissure
6. Anal stricture
7. Current or previous rectovaginal fistula (previous/last pelvic MRI).
A previous seton placement, abscess drainage, fistulotomy and lay open fistula are not an exclusion criteria. Patients with a current seton can only be included if the seton was place more than 24 weeks ago, and the endoanal ultrasound does not show any new/non-treated perianal fistula/abscess.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03819257
Study Brief:
Protocol Section:
NCT03819257