跳至主要内容
临床试验/NCT03555903
NCT03555903招募中不适用

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

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
The impact of the management of deep endometriosis on the quality of life

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • surgically management for deep endometriosis

排除标准

  • No surgical management necessary
  • Isolated Adenomyosis

结局指标

主要结局

The impact of the management of deep endometriosis on the quality of life

时间窗: 5 years

Evolution of EHP-30 quality of life scores.

次要结局

  • Describe diagnostic management of the disease.(5 years)
  • Describe diagnostic delay of the disease.(5 years)
  • Describe endometriosis(5 years)
  • Describe risk factors of the disease.(5 years)
  • Impact of the management of deep endometriosis on the use of assisted reproductive therapy.(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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