Идёт набор NCT05728281

Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy

Без фазы С лечением Time Between Hysterectomy and Resumption of Sexual Relations Sexual Function

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Recommended time after hysterectomy.
Кому может быть актуально: Состояния в реестре: Time Between Hysterectomy and Resumption of Sexual Relations, Sexual Function. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study

Обзор

In France, more than 62 000 hysterectomies are performed each year. Female sexual function is the result of multiple psychological, social and physiological factors. There is no information in the current literature about the optimum time between the surgery and the sexual relation resumption. The primary outcome is to assess the impact of advising time between hysterectomy and sexual relation resumption by using FSFI® score. Secondaries outcomes are: to describe and compare post-operative complications in the two groups of the study, to describe the follow-up of the recommendation concerning time between surgery and sexual relation resumption and to describe why this recommendation was not followed. This study is based on 4 questionnaires: FSFI® pre-operative and post-operative, pre-operative questionnaire and post-operative questionnaire. This is a monocentric, comparative, of superiority, randomised and prospective study. Patients are randomised into two groups: sexual relation resumption advised 4 weeks after surgery, or 8 weeks. The inclusion criteria are more than 18 years, francophone, in sexual activity, scheduled for a total hysterectomy for benign indication (menometrorrhagia, fibroma, adenomyosis, endometriosis, pelvic floor disorders, low-grade endometrial cancer), considering vaginal, laparoscopic and abdominal approach, and a written consent. Non-inclusion criteria are illiteracy, cognitive disorders, without social security, deprived liberty by judicial or administrative decision, psychiatric care, patient with legal protection, patient incapable of giving consent. If our conclusions confirmed our hypothesis, it can improve clinical practices by providing additional informations for surgeon and patient, to undergo this surgery as serenely as possible.

Вмешательства

Другое Recommended time after hysterectomy
Currently there is no consensus on the optimal time to resume sexual activity. Using a randomization, we will therefore compare two groups: one, whose postoperative instructions will indicate a resumption of sexual activity from 4 weeks after the operation and the other from 8 weeks postoperatively. The primary endpoint is the FSFI® score. The patients will answer the FSFI® questionnaire preoperatively and then at 3 months after surgery.

Первичные конечные точки

The Female Sexual Function Index score [Срок оценки: one year]

Вторичные конечные точки (2)

Postoperative complications [Срок оценки: one year]
Follow-up to the recommendation [Срок оценки: one year]

Критерии участия

Критерии включения

Patient ≥ 18 years old,
Francophone,
Sexually active,
Receiving a conservative or non-conservative total hysterectomy for benign pathology\*,
Having signed a consent form. All surgical approaches are considered, laparoscopic approach with laparoscopic or vaginal closure, vaginal approach and laparotomy.

\*The indications for the procedure selected for this study include: