NCT03819257

Anorectal Function in Perianal Crohn's Disease

Evaluation of Anorectal Function in Perianal Crohn's Disease: a Pilot Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 impairment. In refractory cases, a stoma may be necessary. A higher prevalence is seen with increasing Crohn's disease duration and appears to vary according to the disease location. The presence of symptoms associated with anorectal dysfunction, such as fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter abnormalities may have important implications for the future selection of type of delivery, and might even pose a contra-indication for certain types of anorectal surgeries. Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal function are lacking. There is a need for a better understanding of the chronic complications of this disease, and the role of high-resolution anorectal manometry in diagnosing these abnormalities during follow-up of these patients. This study will evaluate the chronic repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or abscess that has healed and/or is inactive.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-19
• Primary completion: 2020-02-22
• Completion: 2020-02-22
• First posted: 2019-01-28
• Last updated: 2020-02-25

Locations

1 site across 1 country: United Kingdom