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Deep Infiltrating EndometriosisENDORAANCT03555903

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

An observational study of Deep Infiltrating Endometriosis, run by Hospices Civils de Lyon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Deep Infiltrating Endometriosis
What is being tested?
Endometriosis cohort
How many people
500 participants
Where
1 siteFrance
Study dates
1 May 2018to Feb 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients surgically managed for deep endometriosis in Centre hospitalier Lyon sud, Lyon, France

Who may be able to join

  • surgically management for deep endometriosis

Who cannot join

  • No surgical management necessary
  • Isolated Adenomyosis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alix SESQUES, MD contact

alix.sesques@chu-lyon.fr

France1 site, 1 recruiting
  • Centre hospitalier Lyon sud

    Pierre-Bénite, 69495

    François GOLFIER, MD, 0478864179 ext. +33, francois.golfier@chu-lyon.fr

    Alix SESQUES, MD, alix.sesques@chu-lyon.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Being tested
Endometriosis cohort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endometriosis cohortOther

    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.

Study groups in NCT03555903
Study groupRoleWhat they receive
Endometriosis cohortThe 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.
Receives: Other: Endometriosis cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Evolution of SF 36 quality of life scores.

    Measured: 5 years

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

    Evolution of EHP-30 quality of life scores.

    Measured: 5 years

Secondary outcomes (6)
  1. Describe endometriosis

    Description of the study population : Socio-demographic data

    Measured: 5 years

  2. Describe risk factors of the disease.

    Postoperative complications (DINDO classification)

    Measured: 5 years

  3. Describe diagnostic delay of the disease.

    Description of diagnostic.

    Measured: 5 years

  4. Describe diagnostic management of the disease.

    Description of therapeutic management : Diagnostic loadings

    Measured: 5 years

  5. Impact of the management of deep endometriosis on the use of assisted reproductive therapy.

    Impact on fertility.

    Measured: 5 years

  6. Describe risk factors of the disease.

    Recurrence of endometriosis.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start1 May 2018
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555903
Sponsor's protocol ID
69HCL17_0813
Acronym
ENDORAA
Status last verified
Jul 2021
First submitted
23 Jan 2018
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Deep Infiltrating Endometriosis, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François GOLFIER, MD (0478864179 ext. +33, francois.golfier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The impact of the management of deep endometriosis on the quality of life (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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