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Recruiting NCT07519850

NCT07519850 The Impact of Perianal Disease on Patient's Sex Life

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Clinical Trial Summary
NCT ID NCT07519850
Status Recruiting
Phase
Sponsor AHEPA University Hospital
Condition Perianal Crohn Disease
Study Type OBSERVATIONAL
Enrollment 60 participants
Start Date 2026-03-31
Primary Completion 2026-05-15

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Patient Reported Outcome Assessment (Questionnaires)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 60 participants in total. It began in 2026-03-31 with a primary completion date of 2026-05-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Active malignancy (colorectal or anal cancer). * Major pelvic surgery in the last 3 months (unrelated to perianal disease). * Cognitive impairment preventing survey completion.

Contact & Investigator

Central Contact

Moysis G. Moysidis, MD, MSc, PhD

✉ mmoisidis@ahepahosp.gr

📞 00306936071666

Frequently Asked Questions

Who can join the NCT07519850 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Perianal Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07519850 currently recruiting?

Yes, NCT07519850 is actively recruiting participants. Contact the research team at mmoisidis@ahepahosp.gr for enrollment information.

Where is the NCT07519850 trial being conducted?

This trial is being conducted at Thessaloniki, Greece.

Who is sponsoring the NCT07519850 clinical trial?

NCT07519850 is sponsored by AHEPA University Hospital. The trial plans to enroll 60 participants.

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