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Набор скоро начнётся NCT06997809

ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery

Без фазы С лечением Endometriosis, Pain

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: pathway care.
Кому может быть актуально
Состояния в реестре: Endometriosis, Pain. Базовые параметры: 18 лет — 50 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
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Обзор

Endometriosis surgery is required when medical treatment fails to release women from pain. However, complete surgery does not work every time to improve patients' symptoms. Algological care is one of the options to treat the pain before surgery and their related complications (neuropathy, sensitization, and catastrophism) that could be associated to nociceptive pain. But not all patients could benefit from this pathway and no screening strategy does exist to detect these complications that could be treated prior to endometriosis surgery

Вмешательства

  • Другое pathway care
    Group for whom the test results will be used to determine the management strategy. If one of the tests performed before randomization is positive an algological consultation before surgery will be performed with an adapted treatment. Then surgical treatment as planned. If all tests are negative, surgical treatment is performed. The dedicated algology consultation must be done with an experienced practitioner different from the one who will perform the surgery. A rapid algological treatment circ

Первичные конечные точки

  • Evaluation of quality of life [Срок оценки: 1 year after surgery]
Вторичные конечные точки (8)
  • Evaluation of satisfaction [Срок оценки: 6 months and 1 year after surgery]
  • Evaluation of endometriosis-specific pain [Срок оценки: From randomization to 6 months and 1 year]
  • Evaluation of pain according to a Simple Numerical Scale (NSS) [Срок оценки: 6 months and 1 year after surgery]
  • Improvement of EHP5 score [Срок оценки: 6 months and 1 year after surgery]
  • Assessment of prevalence of complex pain syndrome [Срок оценки: Baseline]
  • Assessment of determinant of complex pain syndrom of endometriosis [Срок оценки: Baseline]
  • Calculation of the performance of the CSI test [Срок оценки: Baseline]
  • Calculation of performance of each test and correlation [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Maternal age from 18 up to 50 years old (50 non included).
  • Women affiliated to social coverage insurance
  • Women who understand French
  • Women who signed the written consent
  • Women with impaired quality of life (pain) linked to endometriosis
  • Women with formal radiological signs of endometriosis (MRI lesions more than 5 mm or endometrioma more than 20 mm on radiological examinations).
  • Surgical indication for resection of lesions by laparoscopy or robotic surgery for management of pain or impairment of quality of life
  • Patients requiring complete conservative or radical resections of all lesions
  • Indication of surgery validated within dedicated meeting for endometriosis.
  • Purpose of pain associated or not with infertility
  • Date of surgery fixed with sufficient time for algological treatment. Maximum delay of 4 months between randomization and surgery

Критерии исключения

  • Women undergoing surgery for the purpose of infertility
  • Patient with previous surgery for removal of deep lesions of endometriosis or endometriotic cysts (history of exploratory laparoscopy accepted)
  • Patient with suspicious lesions on MRI or specialized ultrasound.
  • A patient who needs to be treated for another uterine pathology at the same time.
  • Pregnant women
  • Patient with a desire for pregnancy immediately and/or within one year after surgery
  • Women who refuse clinical examination (some algological tests couldn't be performed without clinical examination)
  • Patient who has already received algological treatment or who should receive it before surgery
  • Patient with previous other psychiatric disorders (depressive symptoms treated)
  • Women without rights

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Диагностика

Центры проведения

Франция · 9 центров
  • Bordeaux University Hospital — Bordeaux
  • IFEMENDO — Bordeaux
  • Versailles Hospital — Le Chesnay
  • Saint-Vincent-de-Paul Hospital — Lille
  • Limoges University hospital — Limoges
  • Poissy-St-Germain Intercommunal hospital center — Poissy
  • Poitiers University Hospital — Poitiers
  • Mutual Clinic La Sagesse — Rennes
  • … и ещё 1 центр

Идентификаторы

NCT: NCT06997809 · 87RI23_0049 (ENDALGO)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗