Clinical trial NCT01635543: Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas
Official title: Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Crohn's Disease
Peri-anal Fistulas
Sexual Dysfunction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women ages 19-70 years old with Crohn's disease and sexually active in the last 4 weeks.

Brief 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).

Eligibility criteria: Inclusion Criteria:

* patients in a stable sexual relationship between 19-70 years old with Crohn's Disease
* Crohn's disease diagnosis is based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months
* Patients 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.

Primary outcomes:
measure: CD patients without perianal fistulas will be compared with CD patients with perianal fistulas in terms of the percentage of patients that exhibit our definition of sexual dysfunction.
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Gastroenterology Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brian Bressler, MD
role: PRINCIPAL_INVESTIGATOR
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