The Impact of Perianal Disease on Patient's Sex Life (SEXTON)

April 2, 2026 updated by: Moysis Moysidis, AHEPA University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Thessaloniki
      • Thessaloniki, Thessaloniki, Greece, 54636
        • Recruiting
        • Ahepa University General hospital
        • Contact:
        • Sub-Investigator:
          • Vassilis Stergios, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Perianal Disease Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Collaborators

Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10444_16/03/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of participants regarding sensitive psychosexual and behavioral data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perianal Abscess

Clinical Trials on Patient Reported Outcome Assessment (Questionnaires)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe