Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •All patients with known depression will be excluded from the study to prevent confounding the findings.
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点