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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Mesut Yavaş, MD, Assistant of Professor
- 電話番号：+905019127287
- メール：mesutyavas@gazi.edu.tr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Total Female Sexual Function Index Score From Baseline to 6 Months
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mesut Yavaş, MD, Assistant of Professor、Gazi University Faculty of Medicine
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GU-PERISEX-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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