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.
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
France1 site, 1 recruiting
- 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
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.
- 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.
- 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.
- Conditions
- Deep Infiltrating Endometriosis
- 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 group | Role | What they receive |
|---|---|---|
| Endometriosis cohort | 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. Receives: Other: Endometriosis cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of the management of deep endometriosis on the quality of life
Evolution of SF 36 quality of life scores.
Measured: 5 years
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)
Describe endometriosis
Description of the study population : Socio-demographic data
Measured: 5 years
Describe risk factors of the disease.
Postoperative complications (DINDO classification)
Measured: 5 years
Describe diagnostic delay of the disease.
Description of diagnostic.
Measured: 5 years
Describe diagnostic management of the disease.
Description of therapeutic management : Diagnostic loadings
Measured: 5 years
Impact of the management of deep endometriosis on the use of assisted reproductive therapy.
Impact on fertility.
Measured: 5 years
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.
- First posted14 Jun 2018
- Study start1 May 2018
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Infiltrating EndometriosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort
- ClinicalTrials.gov ID
- NCT03555903
- Acronym / sponsor ID
- ENDORAA / 69HCL17_0813
- Conditions
- Deep Infiltrating Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis cohort | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients surgically managed for deep endometriosis in Centre hospitalier Lyon sud, Lyon, France
Key inclusion criteria (1 listed)
- surgically management for deep endometriosis
Key exclusion criteria (2 listed)
- No surgical management necessary
- Isolated Adenomyosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometriosis cohortThe 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. | Other | Endometriosis cohort |
Primary outcome
The impact of the management of deep endometriosis on the quality of life
Time frame: 5 years
Evolution of SF 36 quality of life scores.
The impact of the management of deep endometriosis on the quality of life
Time frame: 5 years
Evolution of EHP-30 quality of life scores.
6 secondary outcomes
Describe endometriosis
Time frame: 5 years
Describe risk factors of the disease.
Time frame: 5 years
Describe diagnostic delay of the disease.
Time frame: 5 years
Describe diagnostic management of the disease.
Time frame: 5 years
Impact of the management of deep endometriosis on the use of assisted reproductive therapy.
Time frame: 5 years
Describe risk factors of the disease.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alix SESQUES, MD contact
1 site in 1 country: see every site and its status.
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.