An observational study in Perianal Crohn Disease, Perianal Fistula and Fistula in Ano, sponsored by AHEPA University Hospital. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by AHEPA University Hospital · Observational
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.
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.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 60 is below the median of 85 across 46 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →AHEPA University Hospital is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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).
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
Plan to share: No — To protect the privacy of participants regarding sensitive psychosexual and behavioral data.
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