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Trials / Withdrawn

WithdrawnNCT01635543

Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
University of British Columbia · Academic / Other
Sex
All
Age
19 Years – 70 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Timeline

Start date
2011-10-01
Primary completion
2013-06-01
Completion
2013-10-01
First posted
2012-07-09
Last updated
2013-10-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01635543. Inclusion in this directory is not an endorsement.

Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas (NCT01635543) · Clinical Trials Directory