Clinical trial NCT03555903: Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort
Official title: Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Infiltrating Endometriosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients surgically managed for deep endometriosis in Centre hospitalier Lyon sud, Lyon, France

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* surgically management for deep endometriosis

Exclusion Criteria:

* No surgical management necessary
* Isolated Adenomyosis

Primary outcomes:
measure: The impact of the management of deep endometriosis on the quality of life
timeFrame: 5 years
measure: The impact of the management of deep endometriosis on the quality of life
timeFrame: 5 years
Secondary outcomes:
measure: Describe endometriosis
timeFrame: 5 years
measure: Describe risk factors of the disease.
timeFrame: 5 years
measure: Describe diagnostic delay of the disease.
timeFrame: 5 years
measure: Describe diagnostic management of the disease.
timeFrame: 5 years
measure: Impact of the management of deep endometriosis on the use of assisted reproductive therapy.
timeFrame: 5 years
measure: Describe risk factors of the disease.
timeFrame: 5 years
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre hospitalier Lyon sud
Study officials:
References: