The "Hidden Morbidity" of Perianal Disease: A Prospective Evaluation of Psychosexual Health and Body Image.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Intimacy Distress Score (IDS)
研究概览
简要总结
Perianal diseases, such as perianal abcesses, anal fistulae and perianal Crohn's disease, are often associated with significant physical symptoms, including pain and chronic drainage. However, the impact of these conditions on a patient's personal life, intimacy, and body image-often referred to as "hidden morbidity"-is frequently overlooked in clinical practice.
The purpose of this prospective observational study is to evaluate the psychosexual burden in patients suffering from chronic perianal disease. Using validated tools (IIEF-5 for men, FSFI-6 for women) and a specialized Supplemental Patient-Reported Outcome Measure (PROM), researchers will investigate how the presence of surgical devices (such as setons), disease etiology, and clinical symptoms affect sexual function and self-esteem.
The study also aims to identify gaps in physician-patient communication regarding sexual health. By quantifying these impacts, the study seeks to promote a more holistic, patient-centered approach to the surgical management of perianal conditions.
详细描述
Background and Rationale:
While surgical success in proctology is traditionally measured by healing rates and recurrence, recent literature suggests that the psychosexual impact of perianal disease is a major determinant of overall quality of life. Chronic drainage, pain, and the physical presence of seton drains can lead to "internalized shame," body image disturbance, and avoidance of intimacy. Current surgical counseling often fails to address these sensitive topics, leaving a significant gap in patient care.
Study Design:
This is a prospective, cross-sectional, observational study. No interventional procedures or deviations from standard-of-care treatments will occur.
Participant Flow and Procedures:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic perianal disease (fistula-in-ano, pCD, pilonidal).
- •Age >18 years.
- •Ability to understand and complete the Greek versions of the IIEF-5/FSFI-6 and the study PROM.
- •Signed informed consent.
排除标准
- •Active malignancy (colorectal or anal cancer).
- •Major pelvic surgery in the last 3 months (unrelated to perianal disease).
- •Cognitive impairment preventing survey completion.
研究组 & 干预措施
Chronic Perianal Disease Cohort
Adult patients (aged 18-70) diagnosed with chronic perianal conditions, including perianal Crohn's disease, cryptoglandular anal fistulae, anal fissure/ fistulae, and pilonidal disease. This cohort includes patients at various stages of surgical management, including those with active seton drainage and those post-definitive repair.
干预措施: Patient Reported Outcome Assessment (Questionnaires) (Behavioral)
结局指标
主要结局
Total Intimacy Distress Score (IDS)
时间窗: Baseline
A composite score derived from the 6 Likert-scale questions of the "Hidden Morbidity" PROM and 4 yes/ no questions. This score will be evaluated alongside with a 10-cm Visual Analog Scale (VAS) where patients mark their level of self-confidence regarding their body image and sexuality. The scale ranges from 0 (No confidence) to 10 (Full confidence).
次要结局
- The Seton Factor(Baseline)
- Comparison of Psychosexual Distress Between Crohn's and Cryptoglandular Disease.(Baseline)
- Male/ Female Sexual Function(Baseline)
- Impact of Perianal Disease on Receptive Anal Intercourse Functionality.(Baseline)
研究者
Moysis Moysidis
Consultant General Surgeon
AHEPA University Hospital