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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Deep Infiltrating Endometriosis

Treatments: Other: Endometriosis cohort

Study type: Observational

Funder types: Other

Identifiers

NCT03555903

69HCL17_0813

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• surgically management for deep endometriosis

Exclusion criteria

• No surgical management necessary
• Isolated Adenomyosis

Trial design

500 participants in 1 patient group

Endometriosis cohort

Description:

The aim of the study is to advance the scientific knowledge of deep infiltrating endometriosis (DIE) and to evaluate the impact of surgery on the quality of life and the fertility of affected women.

Treatment:

Other: Endometriosis cohort