Anorectal Function in Perianal Crohn's Disease

CompletedOBSERVATIONAL
Enrollment

16

Participants

Timeline

Start Date

January 19, 2019

Primary Completion Date

February 22, 2020

Study Completion Date

February 22, 2020

Conditions
Crohn Disease
Interventions
DIAGNOSTIC_TEST

Endoanal ultrasound

For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.

DIAGNOSTIC_TEST

High-resolution anorectal manometry

"1. rest - basal anal pressures at rest over 60 s~2. squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort~3. cough - anorectal pressure changes during cough~4. push - anorectal pressure changes during simulated defecation~5. rectoanal inhibitory reflex - reflex anal response to rectal distension~6. rectal sensation - assessment of rectal sensitivity to distension."

DIAGNOSTIC_TEST

Balloon expulsion test

A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.

Trial Locations (1)

LS7 4SA

Leeds Teaching Hospital NHS Trust, Leeds

All Listed Sponsors
lead

The Leeds Teaching Hospitals NHS Trust

OTHER

NCT03819257 - Anorectal Function in Perianal Crohn's Disease | Biotech Hunter | Biotech Hunter