The Impact of Perianal Disease on Patient's Sex Life

NCT07519850 | Recruiting

• 1 other identifier: 10444_16/03/26
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Perianal Crohn Disease; Perianal Fistula; Fistula in Ano; Perianal Abscess; Pilonidal Cyst/Fistula; Anal Fissure and Fistula

Keywords

fistula in ano; perianal fistula; perianal Crohn's disease; anal fissure; psychosexual life; sex life; intimacy; fistula

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline

Secondary Outcomes (4)

• The Seton Factor

  Baseline

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

  Baseline

• Male/ Female Sexual Function

  Baseline

• Impact of Perianal Disease on Receptive Anal Intercourse Functionality.

  Baseline

Study Arms (1)

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)

Interventions

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.

Chronic Perianal Disease Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Active malignancy (colorectal or anal cancer).
• Major pelvic surgery in the last 3 months (unrelated to perianal disease).
• Cognitive impairment preventing survey completion.

Sponsors & Collaborators

• AHEPA University Hospital: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

AHEPA University General Hospital

Thessaloniki, Thessaloniki, 54636, Greece

RECRUITING

Related Publications (6)

• 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.

  PMID: 17680311 BACKGROUND

• Komov 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.

  PMID: 29707912 BACKGROUND

• Shlomo 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 Feb 16. doi: 10.1007/s10620-026-09766-0. Online ahead of print.

  PMID: 41697513 BACKGROUND

• Spinelli 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.

  PMID: 37529012 BACKGROUND

• Boudiaf 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.

  PMID: 32961618 BACKGROUND

• Riss 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.

  PMID: 22956209 BACKGROUND

MeSH Terms

Conditions

Rectal Fistula; Fissure in Ano; Fistula

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Anus Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Moysis G. Moysidis, MD, MSc, PhD

CONTACT

00306936071666; mmoisidis@ahepahosp.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General Surgeon

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 9, 2026
• Study Start: March 31, 2026
• Primary Completion: May 15, 2026
• Study Completion: June 20, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)