About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active malignancy (colorectal or anal cancer).
Major pelvic surgery in the last 3 months (unrelated to perianal disease).
Cognitive impairment preventing survey completion.
Trial population
The study population consists of adult patients (men and women, aged 18 and older) diagnosed with chronic perianal conditions who are under the care of the Proctology Clinic at the 3rd Surgical Department of AHEPA University General Hospital of Thessaloniki. The cohort represents a 'real-world' surgical population, including individuals with various underlying etiologies such as cryptoglandular anal fistulae, perianal Crohn's disease, and pilonidal disease.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Patient Reported Outcome Assessment (Questionnaires)
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
Total Intimacy Distress Score (IDS)
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).
Secondary outcomes
The Seton Factor
A sub-group analysis will be performed on patient carrying a seton drain on to identify the impact of a medical device in the perianal region on the psychosexual life of a patient with chronic condition.
Comparison of Psychosexual Distress Between Crohn's and Cryptoglandular Disease.
Evaluation of the difference in the Total Intimacy Distress Score (IDS) between patients with Perianal Crohn's Disease (pCD) and those with cryptoglandular anal fistulae. This analysis aims to determine if the systemic nature of Crohn's disease leads to significantly higher psychosexual morbidity compared to isolated cryptoglandular fistulae.
Male/ Female Sexual Function
A validated 5-item questionnaire used to evaluate male sexual function (specifically erectile function). Each item is scored from 1 to 5. Total scores range from 5 to 25. Scores below 21 indicate the presence of erectile dysfunction (ED), with lower scores representing increased severity of ED. For that, the International Index of Erectile Function (IIEF-5) Score will be used. Also, a validated 6-item short-form questionnaire used to evaluate female sexual function across six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Each item is scored from 1 to 5. Total scores range from 6 to 30, with lower scores indicating a higher risk of female sexual dysfunction (FSD). This will be measured with the use of a translated and validated Female Sexual Function Index (FSFI-6) Score Questionnaire.
Impact of Perianal Disease on Receptive Anal Intercourse Functionality.
A subgroup analysis comparing the Total Intimacy Distress Score (IDS) and Positioning Limitations (Question 9 of the PROM) between patients who engage in receptive anal intercourse and those who do not. This measure aims to quantify the specific functional barriers and psychological distress (fear of pain/leakage) unique to this anatomical practice in the presence of perianal disease or seton drains.
Sponsors and contacts
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AHEPA University Hospital
Lead sponsor
Aristotle University Of Thessaloniki
Collaborator