The Impact of Perianal Disease on Patient's Sex Life

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Total Intimacy Distress Score (IDS) [Срок оценки: Baseline]

Вторичные конечные точки (4)

• The Seton Factor [Срок оценки: Baseline]
• Comparison of Psychosexual Distress Between Crohn's and Cryptoglandular Disease. [Срок оценки: Baseline]
• Male/ Female Sexual Function [Срок оценки: Baseline]
• Impact of Perianal Disease on Receptive Anal Intercourse Functionality. [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 1 центр

• AHEPA University General Hospital — Thessaloniki

Публикации

• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07519850 · 10444_16/03/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗