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Clinical Trial Summary

Objective:

The aim of this study is to investigate whether Crohn's Disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's Disease patients that would benefit from sexual health interventions.

Hypothesis:

Crohn's patients with active perianal fistulas will have decreased sexual drive, performance, and satisfaction than those with Crohn's Disease in remission.


Clinical Trial Description

Subject Selection:

Inclusion Criteria Patients in a stable sexual relationship between the ages of 19 and 70 of both sexes with Crohn's disease, as diagnosed based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months will be included in this study. Patients included in this study will have been sexually active in the last 4 weeks.

Exclusion Criteria All patients with known depression will be excluded from the study to prevent confounding the findings.

Patients that qualify for the study will be recruited, and be divided into inactive Crohn's Disease group with no peri-anal fistulas as a control group and an active Crohn's Disease with peri-anal fistula as the study group. Inactive Crohn's Disease patients will be defined as patients with Harvey-Bradshaw scores below 5. Fistula patients will be defined as patients with single or multiple draining fistulas, including perianal fistulas and enterocutaneous fistulas, for at least three months (17). ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01635543
Study type Observational
Source University of British Columbia
Contact
Status Withdrawn
Phase N/A
Start date October 2011
Completion date October 2013

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