Prospective Evaluation of Female Sexual Function Following Surgical Treatment of Benign Perianal Diseases: A Single-Center Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Surgical Treatment for Benign Perianal Diseases (Procedure)
结局指标
主要结局
未指定
次要结局
- Change in Total Female Sexual Function Index Score From Baseline to 3 Months(Baseline and postoperative 3 months)
- Disease-specific Change in Total FSFI Score(Baseline, postoperative 3 months, and postoperative 6 months)
研究者
Mesut YAVAS
Assistant of Professor of Surgery
Gazi University