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NCT Number: NCT07519850

The Impact of Perianal Disease on Patient's Sex Life

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AHEPA University General Hospital

Thessaloniki, 54636, Greece

Location status: Recruiting

Location contact

Vassilis Stergios, MD

CONTACT

[email protected]

00302313303197 ext. 197

Vassilis Stergios, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient Reported Outcome Assessment (Questionnaires)

Behavioral

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.

Primary outcomes

  1. Total Intimacy Distress Score (IDS)

    Time frame: 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).

Secondary outcomes

  1. The Seton Factor

    Time frame: Baseline

    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.

  2. Comparison of Psychosexual Distress Between Crohn's and Cryptoglandular Disease.

    Time frame: Baseline

    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.

  3. Male/ Female Sexual Function

    Time frame: Baseline

    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.

  4. Impact of Perianal Disease on Receptive Anal Intercourse Functionality.

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Moysis G. Moysidis, MD, MSc, PhD

CONTACT

[email protected]

00306936071666

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Collaborators

  • Aristotle University Of Thessaloniki

Registry information

Official study title

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

Acronym: SEXTON

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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