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Female Sexual Function After Surgery for Benign Perianal Diseases (PERISEX)

24. juni 2026 opdateret af: Mesut YAVAS, Gazi University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Sexually active women undergoing surgical treatment for benign perianal diseases at Gazi University Faculty of Medicine.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Procedure: Surgical Treatment for Benign Perianal Diseases
Standard surgical treatment for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula according to routine clinical indications. No experimental intervention will be administered.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Female Sexual Function Index Score From Baseline to 6 Months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gazi University

Efterforskere

  • Ledende efterforsker: Mesut Yavaş, MD, Assistant of Professor, Gazi University Faculty of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GU-PERISEX-2026

Plan for individuelle deltagerdata (IPD)

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