Status:
COMPLETED
Anorectal Function in Perianal Crohn's Disease
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Brief Summary
Perianal Crohn's disease is a disabling disease associated with increased morbidity and impaired quality of life. It is associated with pain, discharge, fecal incontinence and sexual and psychological...
Eligibility Criteria
Inclusion
- ≥ 18 and ≤ 75 year-old patients
- CD in clinical remission, defined by a Harvey-Bradshaw index \<5
- Perianal CD history, defined by the presence of a perianal fistula and/or abscess that were treated/heal/inactive
- Perianal Disease Activity Index (PDAI) of ≤4
- 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
- Endoanal ultrasound without an image compatible with new/non-treated abscess or perianal fistula
- Both previous simple or complex perianal fistula (according to the American College of Gastroenterology) will be considered.
Exclusion
- Women with previous vaginal delivery
- Ileostomy
- Previous anorectal surgery as hemorrhoidectomy or lateral sphincterotomy
- 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
- Previous or current anal fissure
- Anal stricture
- 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.
Key Trial Info
Start Date :
January 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 22 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03819257
Start Date
January 19 2019
End Date
February 22 2020
Last Update
February 25 2020
Active Locations (1)
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1
Leeds Teaching Hospital NHS Trust
Leeds, United Kingdom, LS7 4SA