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Идёт набор NCT07389863

Evaluation of Gynecological and Sexual Sequelae

— Наблюдательное Rectal Cancer Patients

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Rectal Cancer Patients. Базовые параметры: 18 лет — 60 лет · Все.
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
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Официальное название

Evaluation of Gynecological and Sexual Sequelae in Patients Treated for Rectal Cancer

Обзор

Rectal cancer accounts for approximately 40% of colorectal cancers. In France, there are 15,000 new cases per year, and the 5-year survival rate is 55% across all stages. Treatment involves surgical resection of the rectum, often combined with preoperative chemoradiotherapy and sometimes immunotherapy, depending on the tumor's immunohistochemical status. This treatment strategy has improved recurrence-free survival but is associated with long-term functional complications affecting the digestive, urological, gynecological, and sexual systems. Surgery causes anatomical changes and damage to the autonomic nervous system plexuses. Radiotherapy, for its part, causes pelvic inflammation with the development of fibrosis and potential vascular and nerve damage. Various disorders can arise as a result of these anatomical changes, such as erectile dysfunction in men; dyspareunia and vaginal dryness in women; urinary incontinence and impaired sexual quality of life in both sexes.

Подробное описание

In women, there is a significant link between gynecological clinical abnormalities and the onset of sexual dysfunction. Gynecological anatomical sequelae are a major determinant of female sexual health. However, their assessment in clinical practice in the context of rectal cancer remains inconsistent, incomplete, or delayed. The repercussions of impaired sexual quality of life are also significant from a public health perspective. Good sexual quality of life is directly linked to a better overall quality of life in women over 40. These results could therefore be extrapolated to patients experiencing sexual dysfunction after treatment for rectal cancer. Finally, impaired overall quality of life leads to increased healthcare utilization and disability, with significant socioeconomic repercussions.

Gynecological and sexual sequelae following treatment for rectal cancer are therefore frequent but insufficiently assessed and managed in clinical practice, despite their impact on patients' overall quality of life and on public health. This work would allow for a better understanding of these disorders in order to prevent, assess, and manage them more effectively and thus optimize patients' future quality of life.

Первичные конечные точки

  • To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. [Срок оценки: 1 day]
  • To assess the characteristics of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. [Срок оценки: 1 day]
Вторичные конечные точки (3)
  • Identify the main risk factors for gynecological and sexual sequelae in patients [Срок оценки: 1 day]
  • Evaluate the relevance of the GynéRect questionnaire for assessing the gynecological and sexual sequelae of patients [Срок оценки: 1 day]
  • Évaluer l'impact des séquelles gynécologiques et sexuelles des patientes sur leur qualité de vie globale [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • Women aged 18 to 60 at the time of diagnosis
  • Having been treated for rectal cancer between 2020 and 2025
  • Cancer in remission
  • Having been sexually active before receiving treatment for their rectal cancer
  • Having completed the various questionnaires during their treatment

Критерии исключения

  • Inability to complete questionnaires (cognitive impairment, language barrier)
  • Pregnant women
  • Women with active cancer and/or undergoing chemotherapy
  • Women with a history of extensive gynecological surgery
  • Individuals deprived of their liberty by an administrative or judicial decision, or individuals under legal protection/guardianship or curatorship
  • Individuals without social security coverage

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • Service de Chirurgie Digestive — Rouen

Идентификаторы

NCT: NCT07389863 · 2025/0441/OB · 2025-A02592-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗