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

Withdrawn

• Conditions: Crohn's Disease; Peri-anal Fistulas; Sexual Dysfunction

• Registration Number: NCT01635543
• Lead Sponsor: University of British Columbia

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).

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-09
• Primary Completion: 2013-06
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-16
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1.5 years	Student t-test will be used to compare the difference between the fistula versus the control group. Statistical analysis will be two tailed and our p value will be set up as p \<0.05. We estimate that 30% of patients with CD will have sexual dysfunction, and that 65% of CD patients with peri-anal fistulas will have sexual dysfunction. Therefore, our calculated sample size for both groups will be around 31 patients each for 80% power with an alpha of 0.05.

Trial Locations

Locations (1)

Gastroenterology Research Institute; 🇨🇦 Vancouver, British Columbia, Canada