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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03555903
Acronym
ENDORAA
Enrollment
500
Registered
2018-06-14
Start date
2018-05-01
Completion date
2028-02-29
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Infiltrating Endometriosis

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.

Interventions

OTHEREndometriosis 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* surgically management for deep endometriosis

Exclusion criteria

* No surgical management necessary * Isolated Adenomyosis

Design outcomes

Primary

MeasureTime frameDescription
The impact of the management of deep endometriosis on the quality of life5 yearsEvolution of SF 36 quality of life scores.

Secondary

MeasureTime frameDescription
Describe endometriosis5 yearsDescription of the study population : Socio-demographic data
Describe risk factors of the disease.5 yearsPostoperative complications (DINDO classification)
Describe diagnostic delay of the disease.5 yearsDescription of diagnostic.
Describe diagnostic management of the disease.5 yearsDescription of therapeutic management : Diagnostic loadings
Impact of the management of deep endometriosis on the use of assisted reproductive therapy.5 yearsImpact on fertility.

Countries

France

Contacts

Primary ContactFrançois GOLFIER, MD
francois.golfier@chu-lyon.fr0478864179
Backup ContactAlix SESQUES, MD
alix.sesques@chu-lyon.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026