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Anorectal Function in Perianal Crohn's Disease

NCT03819257 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-02-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-19
Primary Completion
2020-02-22
Completion
2020-02-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819257 on ClinicalTrials.gov