Female Sexual Function After Surgery for Benign Perianal Diseases (PERISEX)
Prospective Evaluation of Female Sexual Function Following Surgical Treatment of Benign Perianal Diseases: A Single-Center Observational Cohort Study
Benign perianal diseases such as chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula may negatively affect female sexual function through pain, bleeding, discharge, discomfort, and impairment in quality of life. Although improvement in male sexual function after surgery for benign anorectal disorders has been reported, data regarding female sexual function remain limited.
This prospective observational cohort study aims to evaluate changes in Female Sexual Function Index (FSFI) scores following surgical treatment of benign perianal diseases. Female patients undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be assessed preoperatively and at postoperative 3 and 6 months using the FSFI, Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS).
The primary objective is to determine whether female sexual function improves following surgical treatment. Secondary objectives include evaluating the relationship between symptom improvement, continence status, pain reduction, and changes in female sexual function.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Female sexual function is a multidimensional concept influenced by physical, psychological, and social factors. Benign perianal diseases are common surgical conditions that may adversely affect sexual function through chronic pain, bleeding, discharge, prolapse, discomfort, embarrassment, and reduced quality of life.
Previous studies have demonstrated impaired sexual function among patients with anorectal disorders. Furthermore, improvement in male sexual function following surgical treatment of benign anorectal diseases has been reported. However, prospective data regarding female sexual function after surgical treatment of benign perianal diseases remain scarce.
This single-center prospective observational cohort study will be conducted at Gazi University Faculty of Medicine. Sexually active women aged 18 to 70 years undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be enrolled.
Participants will complete the Female Sexual Function Index (FSFI), Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS) questionnaires before surgery and at postoperative 3 and 6 months.
The primary outcome will be the change in total FSFI score from baseline to postoperative 6 months. Secondary outcomes will include changes in FSFI at 3 months, changes in CCIS and VAS scores, and subgroup analyses according to disease type and symptom severity.
The investigators hypothesize that successful surgical treatment of benign perianal diseases will result in significant improvement in female sexual function and that this improvement will correlate with reductions in pain and disease-related symptoms.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mesut Yavaş, MD, Assistant of Professor
- Numéro de téléphone: +905019127287
- E-mail: mesutyavas@gazi.edu.tr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Female patients aged 18-70 years
- Sexually active during the previous 4 weeks
- Diagnosed with chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula
- Scheduled for surgical treatment according to routine clinical indications
- Able to understand and complete study questionnaires
- Willing to provide written informed consent
Exclusion Criteria:
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Pregnancy
- Postpartum period within the previous 12 months
- Pelvic organ prolapse
- Previous treatment for female sexual dysfunction
- Current antidepressant medication use
- Active psychiatric disorder
- Gynecological malignancy
- Previous pelvic radiotherapy
- Inability or unwillingness to complete study questionnaires
- Refusal to provide informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Women Undergoing Benign Perianal Surgery
Sexually active female patients aged 18 to 70 years undergoing surgical treatment for benign perianal diseases, including chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula.
Participants will be prospectively assessed using FSFI, CCIS/Wexner, and VAS scores at baseline and postoperative follow-up.
|
Standard surgical treatment for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula according to routine clinical indications.
No experimental intervention will be administered.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Total Female Sexual Function Index Score From Baseline to 6 Months
Délai: Baseline and postoperative 6 months
|
Change in total Female Sexual Function Index (FSFI) score between the preoperative baseline assessment and postoperative 6-month follow-up.
The FSFI total score ranges from 2 to 36, with higher scores indicating better female sexual function.
|
Baseline and postoperative 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months
Délai: Baseline and postoperative 6 months
|
Change in Cleveland Clinic Incontinence Score/Wexner score between baseline and postoperative 6 months.
The score ranges from 0 to 20, with higher scores indicating more severe fecal incontinence.
|
Baseline and postoperative 6 months
|
|
Change in Visual Analog Scale Pain Score From Baseline to 6 Months
Délai: Baseline and postoperative 6 months
|
Change in anal pain assessed using a 0-10 Visual Analog Scale between baseline and postoperative 6 months.
Higher scores indicate more severe pain.
|
Baseline and postoperative 6 months
|
|
Change in Total Female Sexual Function Index Score From Baseline to 3 Months
Délai: Baseline and postoperative 3 months
|
Change in total Female Sexual Function Index (FSFI) score between the preoperative baseline assessment and postoperative 3-month follow-up.
The FSFI total score ranges from 2 to 36, with higher scores indicating better female sexual function.
|
Baseline and postoperative 3 months
|
|
Disease-specific Change in Total FSFI Score
Délai: Baseline, postoperative 3 months, and postoperative 6 months
|
Comparison of change in total Female Sexual Function Index (FSFI) score among disease subgroups, including chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula.
The FSFI total score ranges from 2 to 36, with higher scores indicating better female sexual function.
|
Baseline, postoperative 3 months, and postoperative 6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mesut Yavaş, MD, Assistant of Professor, Gazi University Faculty of Medicine
Publications et liens utiles
Publications générales
- Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Buyukkasap C, Bostanci H, Dikmen K, Gobut H, Yavuz A, Altiner S, Bolukbasi B, Atan A. Sexual Function After Surgical Treatment for Benign Anorectal Disorders. Am J Mens Health. 2024 May-Jun;18(3):15579883241252016. doi: 10.1177/15579883241252016.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GU-PERISEX-2026
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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