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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Mesut Yavaş, MD, Assistant of Professor
- Номер телефона: +905019127287
- Электронная почта: mesutyavas@gazi.edu.tr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Total Female Sexual Function Index Score From Baseline to 6 Months
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Mesut Yavaş, MD, Assistant of Professor, Gazi University Faculty of Medicine
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GU-PERISEX-2026
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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