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Female Sexual Function After Surgery for Benign Perianal Diseases

ConditionsChronic Anal FissureHemorrhoidal DiseaseCryptoglandular Anal Fistula
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorGazi University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Pregnancy

Postpartum period within the previous 12 months

Pelvic organ prolapse

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgical Treatment for Benign Perianal Diseases

    Procedure/Surgery

    Standard surgical treatment for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula according to routine clinical indications. No experimental intervention will be administered.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Women Undergoing Benign Perianal Surgery1 intervention

Trial outcomes

Primary outcomes

1

Change in Total Female Sexual Function Index Score From Baseline to 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.

Time frame
Baseline and postoperative 6 months

Secondary outcomes

1

Change in Total Female Sexual Function Index Score From Baseline to 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.

Time frame
Baseline and postoperative 3 months
2

Change in Cleveland Clinic Incontinence Score From Baseline to 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.

Time frame
Baseline and postoperative 6 months
3

Change in Visual Analog Scale Pain Score From Baseline to 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.

Time frame
Baseline and postoperative 6 months
4

Disease-specific Change in Total FSFI Score

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.

Time frame
Baseline, postoperative 3 months, and postoperative 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gazi University

Lead sponsor

Source ClinicalTrials.gov

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