Perianal Crohn DiseaseSEXTONNCT07519850
The Impact of Perianal Disease on Patient's Sex Life
An observational study of Perianal Crohn Disease and Perianal Fistula, run by AHEPA University Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Crohn Disease, Perianal Fistula, Fistula in Ano
- What is being tested?
- Patient Reported Outcome Assessment (Questionnaires)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 31 Mar 2026to 20 Jun 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Active malignancy (colorectal or anal cancer).
- Major pelvic surgery in the last 3 months (unrelated to perianal disease).
- Cognitive impairment preventing survey completion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University General Hospital
Thessaloniki, Thessaloniki, 54636
Vassilis Stergios, MD, 00302313303197 ext. 197, vasilis_stergios@hotmail.com
Vassilis Stergios, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Perianal Crohn Disease, Perianal Fistula, Fistula in Ano, Perianal Abscess, Pilonidal Cyst/Fistula, Anal Fissure and Fistula
- Being tested
- Patient Reported Outcome Assessment (Questionnaires)
- Keywords
- fistula in ano, perianal fistula, perianal Crohn's disease, anal fissure, psychosexual life, sex life, intimacy, fistula
- Medical subject headings
- Rectal Fistula, Fissure in Ano, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome Assessment (Questionnaires)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient Reported Outcome Assessment (Questionnaires) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perianal Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Moysis Moysidis, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519850
- Sponsor's protocol ID
- 10444_16/03/26
- Acronym
- SEXTON
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of participants regarding sensitive psychosexual and behavioral data.
Publications
Kasparek MS, Glatzle J, Temeltcheva T, Mueller MH, Koenigsrainer A, Kreis ME. Long-term quality of life in patients with Crohn's disease and perianal fistulas: influence of fecal diversion. Dis Colon Rectum. 2007 Dec;50(12):2067-74. doi: 10.1007/s10350-007-9006-5.
PubMed 17680311Komov L, Kadosh DM, Barnea E, Milner E, Hendler A, Admon A. Cell Surface MHC Class I Expression Is Limited by the Availability of Peptide-Receptive "Empty" Molecules Rather than by the Supply of Peptide Ligands. Proteomics. 2018 Jun;18(12):e1700248. doi: 10.1002/pmic.201700248. Epub 2018 Jun 5.
PubMed 29707912Shlomo Y, Lital B, Ofra C, Yehudit C, Rosi G, Tali M, Ariella BS. Effect of Perianal Disease on Quality of Life, Fecal Incontinence, and Sexual Function in Patients with Crohn's Disease. Dig Dis Sci. 2026 Jul;71(7):2948-2954. doi: 10.1007/s10620-026-09766-0. Epub 2026 Feb 16.
PubMed 41697513Spinelli A, Yanai H, Girardi P, Milicevic S, Carvello M, Maroli A, Avedano L. The Impact of Crohn's Perianal Fistula on Quality of Life: Results of an International Patient Survey. Crohns Colitis 360. 2023 Jul 25;5(3):otad036. doi: 10.1093/crocol/otad036. eCollection 2023 Jul.
PubMed 37529012Boudiaf R, Bouchard D, Riviere P, Brochard C, Laharie D, Abramowitz L, Pigot F; GREP members (Groupe de Recherche en Proctologie). Assessment of sexual dysfunction in patients with perianal Crohn's disease. Colorectal Dis. 2021 Jan;23(1):114-122. doi: 10.1111/codi.15375. Epub 2020 Nov 6.
PubMed 32961618Riss S, Schwameis K, Mittlbock M, Pones M, Vogelsang H, Reinisch W, Riedl M, Stift A. Sexual function and quality of life after surgical treatment for anal fistulas in Crohn's disease. Tech Coloproctol. 2013 Feb;17(1):89-94. doi: 10.1007/s10151-012-0890-x. Epub 2012 Sep 6.
PubMed 22956209