Clinical Trial 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.
