Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort

Обзор

Endometriosis is a common gynaecologic disease affecting 5 to 15% women of reproductive age and up to 40% of infertile women. It is characterized by the presence of active endometrial tissue outside the uterine cavity, potentially causing invalidating chronic pelvic pain and infertility. It is therefore crucial to limit the progression and/or recurrence of the disease, and to improve the quality of life of affected women. Deep infiltrating endometriosis (DIE), an advanced form of the disease, is defined by the invasion of an anatomical structure and organ close to the uterus (i.e. uterosacral ligament, rectovaginal space, recto-sigmoidal colon or bladder), or by a peritoneal invasion greater than 5mm. The management of DIE is unfortunately not yet based on high-level evidence data; it mainly depends on the localization of the disease, the extend of the invasion and the severity of the symptoms. In the absence of clear guidelines based on empirical data, the choice between surgical or medical treatment remains difficult and controversial. To improve optimal DIE management, the investigators aim to create a prospective database reporting on DIE surgically treated in a teaching hospital in Lyon/France (Centre hospitalier universitaire Lyon Sud) Data on known risks factors, symptoms (pain), quality of life, infertility history and disease management will be obtained using self-questionnaires, clinic, paraclinic, surgical and histological records as follow. 1. Each patient will be asked to fill in electronics protected on-line forms: the first one before surgery, followed by three follow-up forms at 1, 2 and 5 years after surgery. 2. The surgeon will be asked to fill in two electronic protected on-line forms: the first one at the time of surgery and the second one during a post-operative consultation (one month after surgery). The questionnaires used in this study are similar to those used for the Endometriosis database "CIRENDO" (explain briefly what it is), which will ultimately allow us to pool the data from the 2 databases. This French prospective study will advance the scientific knowledge on DIE surgical treatment and, by helping evaluate the impact of the surgery on the quality of life and fertility of affected women, will guide future recommendations for an optimal management of this invalidating disease.

Вмешательства

• Другое Endometriosis cohort
  The investigator record data on risks factors, symptoms (pain), quality of life (using standardized quality of life questionnaires), infertility history, and management of the disease with a 5-years follow up. Different surgical procedures exist to treat DIE and are they are described in the database, to allow comparison.

Первичные конечные точки

• The impact of the management of deep endometriosis on the quality of life [Срок оценки: 5 years]
• The impact of the management of deep endometriosis on the quality of life [Срок оценки: 5 years]

Вторичные конечные точки (6)

• Describe endometriosis [Срок оценки: 5 years]
• Describe risk factors of the disease. [Срок оценки: 5 years]
• Describe diagnostic delay of the disease. [Срок оценки: 5 years]
• Describe diagnostic management of the disease. [Срок оценки: 5 years]
• Impact of the management of deep endometriosis on the use of assisted reproductive therapy. [Срок оценки: 5 years]
• Describe risk factors of the disease. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• surgically management for deep endometriosis

Критерии исключения

• No surgical management necessary
• Isolated Adenomyosis

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Centre hospitalier Lyon sud — Pierre-Bénite

Идентификаторы

NCT: NCT03555903 · 69HCL17_0813

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗