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

2026年6月24日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Mesut Yavaş, MD, Assistant of Professor
  • 电话号码：+905019127287
  • 邮箱：mesutyavas@gazi.edu.tr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
程序：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Total Female Sexual Function Index Score From Baseline to 6 Months
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gazi University

调查人员

  • 首席研究员：Mesut Yavaş, MD, Assistant of Professor、Gazi University Faculty of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月26日

上次提交的符合 QC 标准的更新

2026年6月24日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GU-PERISEX-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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