Trials / Recruiting

RecruitingNCT07519850

The Impact of Perianal Disease on Patient's Sex Life

The "Hidden Morbidity" of Perianal Disease: A Prospective Evaluation of Psychosexual Health and Body Image.

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 60 (estimated)

Sponsor: AHEPA University Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: Patients presenting to the Proctology Outpatient Clinic of the 3rd Surgical Department, AHEPA University General Hospital of Thessaloniki with chronic perianal disease (anal fistulae, perianal Crohn's, anal fissure, or pilonidal disease) will be screened. Eligible participants who provide informed consent will complete a one-time assessment consisting of: Demographic and Clinical Data: Age, etiology (e.g. Crohn's vs. Cryptoglandular), duration of disease, and surgical history. Sexual Function Assessment: The International Index of Erectile Function (IIEF-5) for male participants or the Female Sexual Function Index (FSFI-6) for female participants. The "Hidden Morbidity" PROM: A 10-item questionnaire utilizing Likert scales and Visual Analog Scales (VAS) to measure body-esteem, anticipatory anxiety related to pain, and the impact of seton drains. Communication Assessment: Evaluation of whether preoperative counseling included discussions on sexual health and intimacy. Objectives: Primary Objective: To correlate the presence of active perianal disease and surgical setons with sexual dysfunction scores (IIEF-5/FSFI-6). Secondary Objectives: \* To evaluate the impact of disease etiology (Crohn's vs. Cryptoglandular) on body image perception. To assess the specific functional limitations in patients practicing anal intercourse. To quantify the prevalence of "Unmet Patient Needs" regarding professional psychosexual support. Statistical Analysis: A target sample size of 50-80 patients will be enrolled to ensure sufficient power (80%) to detect a medium effect size. Descriptive statistics will summarize demographic data, while t-tests and ANOVA will be used to compare distress scores between subgroups (e.g. Seton vs. No Seton, Crohn's vs. Non-Crohn's). Correlation coefficients (Pearson/Spearman) will analyze the relationship between disease duration and self-esteem scores.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Patient Reported Outcome Assessment (Questionnaires)	A one-time administration of a standardized psychosexual assessment battery. This includes the International Index of Erectile Function (IIEF-5) for males, the Female Sexual Function Index (FSFI-6) for females, and a 10-item supplemental Patient-Reported Outcome Measure (PROM) specifically designed to evaluate body-esteem and intimacy interference in perianal disease.

Timeline

Start date: 2026-03-31
Primary completion: 2026-05-15
Completion: 2026-06-20
First posted: 2026-04-09
Last updated: 2026-04-09

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT07519850. Inclusion in this directory is not an endorsement.