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Набор по приглашению NCT07594327

Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer

Наблюдательное Cervical Cancers Vaginal Cancers Vulvar Cancers Endometrial Cancer

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: Cervical Cancers, Vaginal Cancers, Vulvar Cancers, Endometrial Cancer. 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
Финляндия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Pelvic Exenteration as a Curative Option in Recurrent Gynecological Cancer: Oncological Outcomes and Impact on Quality of Life and Sexuality

Обзор

Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible. The aim of this study is to examine the quality of life and sexuality of patients who have undergone pelvic exenteration. This observational cross-sectional study utilizes internationally validated questionnaires assessing quality of life and sexual function: EORTC QLQ-C30, EORTC QLQ-CX24, and PISQ-12. The findings of this study will provide important guidance for the selection and planning of pelvic exenteration. Improved understanding of postoperative quality of life will support patient selection and enable more comprehensive and individualized patient counseling.

Подробное описание

The investigators will invite living patients who have undergone pelvic exenteration for gynecological cancer at Tampere University Hospital since January 1, 2000, to participate in the study, provided that at least six months have elapsed since the surgery.

The patients are first contacted by telephone to inform them about the study. The investigators will then send an information letter regarding participation, along with questionnaires assessing quality of life and sexuality. There are 21 living patients, most of whom have had cervical cancer. Particular interest will be given to patients who have undergone neovaginal reconstruction, and additional sexuality-related questions have been developed specifically for these patients.

In addition, the medical records of all patients who have undergone pelvic exenteration for gynecological cancer since January 1, 2000, are retrospectively reviewed. Oncological outcomes after pelvic exenteration, factors affecting prognosis, and postoperative complications are assessed.

Первичные конечные точки

  • Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire [Срок оценки: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration]
  • Self-reporterd quality of life measured by EORTC QLQ-CX24 questionnaire [Срок оценки: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration]
  • Self-reported sexuality assessed by the PISQ-12 questionnaire with additional study-specific questions [Срок оценки: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration]

Критерии участия

Критерии включения

  • patient age over 18 years
  • a diagnosis of gynecologic cancer
  • having undergone exenteration surgery on or after January 1, 2000 (at least 6 months prior)
  • the ability to read and write Finnish

Критерии исключения

  • cognitive and/or neurological disease that affects physical functioning and may therefore influence sexual functioning or make it difficult to respond to the questionnaire

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Финляндия · 1 центр
  • Tampere University Hospital — Tampere

Идентификаторы

NCT: NCT07594327 · R25065

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗