EndometriosisENDOLUSNCT03981991
Endometriosis and Quality of Life Assessed by EHP 30
An observational study of Endometriosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Assessment of the quality of life for patients suffering from isolated endometriosic lesion of utero-sacral ligaments diagnosed by MRI, before and after surgical treatment by using French version of Endometriosis Health Profile 30 (EHP 30). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2019to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women during periods of genital activity with medical sign proving endometriotic lesion of utero-sacral ligaments: dysmenorrhea, deep dyspareunia or chronic pelvic pain referred to Obstetrics and Gynecological Department of University Hospital of Grenoble
Who may be able to join
- Patient aged from 18 to 50 years
- Patient with medical sign proving endometriotic lesion: dysmenorrhea, deep dyspareunia or chronic pelvic pain
- Patient with standardized pelvic MRI realized at CHUGA
- Patient with an indication for laparoscopic surgical treatment
- Patient available to complete the questionnaire based on EHP 30
- Patient available for a follow-up of 6 months
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- Patient able to understand and read French language
- Patient affiliated to a social security system or beneficiary of the same.
- Patient who agreed to participate to the research
Who cannot join
- Patient with functional urinary or digestive signs related to endometriotic lesion
- Patient with another deep lesion proved by MRI: endometrioma, rectovaginal septum, recto-sigmoid, urinary bladder, ureters, recto-uterine pouch.
- Virgin patient
- Patient with a contraindication to MRI
- History of extensive pelvic surgery related to endometriosis
- Pregnancy
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- Patient who did not receive laparoscopic treatment of uterosacral ligaments
- Patient already involved in another clinical research study
- Patient in a period of exclusion from another clinical research study
- Referred to the Articles L1121-5, L1121-6, and L1121-8 of the Public Health Code (corresponds to protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, legally protected subject).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38043
Thierry MICHY, MD, +33 (0)4 76 76 66 77, tmichy@chu-grenoble.fr
Pierre PITTET, +33 (0)4 76 76 68 72, ppittet@chu-grenoble.fr
About this study
Official title: Assessment of the Quality of Life for Patients Suffering From Isolated Endometriosic Lesion of Utero-sacral Ligaments Diagnosed by MRI, Before and After Surgical Treatment by Using French Version of Endometriosis Health Profile 30 (EHP30)
Assessment of the quality of life for patients suffering from isolated endometriosic lesion of utero-sacral ligaments diagnosed by MRI, before and after surgical treatment by using French version of Endometriosis Health Profile 30 (EHP 30).
This is prospective, non-controlled, non-randomized, monocentric, observational feasibility study.
Read the detailed description
Endometriosis is a gynecological pathology affecting women during periods of genital activity, which prevalence is underestimated and varies from 10 to 30%. It is characterized by dysmenorrhea, dyspareunia, chronic pelvic pain or infertility. These various manifestations lead to an alteration of the quality of life.
Among women consulting for chronic pelvic pain or suspicion of endometriosis, it is recommended to evaluate pain, as well as suggestive symptoms and localizers using validated quality of life questionnaires such as Endometriosis Health Profile 30 (EHP 30).
In case of chronic pelvic pain and suspicion of a deep lesion, the assessment of disease is based on the interrogation (deep and positional dyspareunia, urinary or digestive catamenial functional signs), pelvic clinical examination by a referral physician, an endovaginal ultrasound by a referral sonographer and pelvic MRI also by a referral radiologist.
However, interpretation is not always easy with a high rate of false negatives. In case of absence of pathognomonic iconographic signs and, if there is an impact on patients' quality of life, a diagnostic laparoscopy can be proposed. This procedure can help to affirm or invalidate endometriotic lesions not visible in imaging, allowing either an excision or lesion destruction.
Although the beneficial role of surgical management in spontaneous fertility has been demonstrated, the clinical benefit of reducing pain and improving the quality of life in isolated uterine sacral ligament lesions has not been demonstrated by clinical studies with a good level of evidence.
Through this study, we would like to evaluate the functional benefit on the quality of life in the short and medium term of laparoscopic surgical management in case of suspicion of isolated uterosacral ligament endometriosis documented by standardized pelvic MRI.
All MRI exams will be analyzed blindly by an expert radiologist.
- Conditions
- Endometriosis
- Keywords
- EHP 30, Endometriosis, Quality of Life, Uterosacral Ligament
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the quality of life of patients before and 3 months after laparoscopic treatment of isolated endometriosic lesions of uterosacral ligaments by French version of the EHP 30 questionnaire.
Overall score and scores by subdomains of EHP 30 questionnaire preoperatively and at 3 months postoperatively.
Measured: 3 months
Secondary outcomes (3)
Evolution of EHP 30 score (and its subdomains) preoperatively, and at 1, 3 and 6 months postoperatively.
Overall score, and scores by subdomains, of EHP 30 questionnaire at 1, 3 and 6 months postoperatively.
Measured: 1 , 3 and 6 months
Assess diagnostic performances of MRI for diagnosis of lesions of uterosacral ligaments by correlating MRI's results with those of laparoscopy.
Uterosacral ligaments (yes / no) on MRI vs. laparoscopy.
Measured: 1 month
Correlate, a posteriori, MRI results with findings of laparoscopy and EHP 30 score evolution
Uterosacral ligaments (yes / no) on MRI vs overall score of EHP 30 questionnaire preoperatively and at 3 months postoperatively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start31 Jul 2019
- Primary completionNov 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry MICHY, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981991
- Sponsor's protocol ID
- 38RC19.130
- Other IDs
- 2019-A01143-54
- Acronym
- ENDOLUS
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2019
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Quality of Life for Patients Suffering From Isolated Endometriosic Lesion of Utero-sacral Ligaments Diagnosed by MRI, Before and After Surgical Treatment by Using French Version of Endometriosis Health Profile 30 (EHP30)
- ClinicalTrials.gov ID
- NCT03981991
- Acronym / sponsor ID
- ENDOLUS / 38RC19.130
- Conditions
- Endometriosis
- Keywords
- EHP 30, Endometriosis, Quality of Life, Uterosacral Ligament
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Jun 2019 (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.
Assessment of the quality of life for patients suffering from isolated endometriosic lesion of utero-sacral ligaments diagnosed by MRI, before and after surgical treatment by using French version of Endometriosis Health Profile 30 (EHP 30).
This is prospective, non-controlled, non-randomized, monocentric, observational feasibility study.
Detailed description
Endometriosis is a gynecological pathology affecting women during periods of genital activity, which prevalence is underestimated and varies from 10 to 30%. It is characterized by dysmenorrhea, dyspareunia, chronic pelvic pain or infertility. These various manifestations lead to an alteration of the quality of life.
Among women consulting for chronic pelvic pain or suspicion of endometriosis, it is recommended to evaluate pain, as well as suggestive symptoms and localizers using validated quality of life questionnaires such as Endometriosis Health Profile 30 (EHP 30).
In case of chronic pelvic pain and suspicion of a deep lesion, the assessment of disease is based on the interrogation (deep and positional dyspareunia, urinary or digestive catamenial functional signs), pelvic clinical examination by a referral physician, an endovaginal ultrasound by a referral sonographer and pelvic MRI also by a referral radiologist.
However, interpretation is not always easy with a high rate of false negatives. In case of absence of pathognomonic iconographic signs and, if there is an impact on patients' quality of life, a diagnostic laparoscopy can be proposed. This procedure can help to affirm or invalidate endometriotic lesions not visible in imaging, allowing either an excision or lesion destruction.
Although the beneficial role of surgical management in spontaneous fertility has been demonstrated, the clinical benefit of reducing pain and improving the quality of life in isolated uterine sacral ligament lesions has not been demonstrated by clinical studies with a good level of evidence.
Through this study, we would like to evaluate the functional benefit on the quality of life in the short and medium term of laparoscopic surgical management in case of suspicion of isolated uterosacral ligament endometriosis documented by standardized pelvic MRI.
All MRI exams will be analyzed blindly by an expert radiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women during periods of genital activity with medical sign proving endometriotic lesion of utero-sacral ligaments: dysmenorrhea, deep dyspareunia or chronic pelvic pain referred to Obstetrics and Gynecological Department of University Hospital of Grenoble
Key inclusion criteria (9 listed)
- Patient aged from 18 to 50 years
- Patient with medical sign proving endometriotic lesion: dysmenorrhea, deep dyspareunia or chronic pelvic pain
- Patient with standardized pelvic MRI realized at CHUGA
- Patient with an indication for laparoscopic surgical treatment
- Patient available to complete the questionnaire based on EHP 30
Key exclusion criteria (10 listed)
- Patient with functional urinary or digestive signs related to endometriotic lesion
- Patient with another deep lesion proved by MRI: endometrioma, rectovaginal septum, recto-sigmoid, urinary bladder, ureters, recto-uterine pouch.
- Virgin patient
- Patient with a contraindication to MRI
- History of extensive pelvic surgery related to endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the quality of life of patients before and 3 months after laparoscopic treatment of isolated endometriosic lesions of uterosacral ligaments by French version of the EHP 30 questionnaire.
Time frame: 3 months
Overall score and scores by subdomains of EHP 30 questionnaire preoperatively and at 3 months postoperatively.
3 secondary outcomes
Evolution of EHP 30 score (and its subdomains) preoperatively, and at 1, 3 and 6 months postoperatively.
Time frame: 1 , 3 and 6 months
Assess diagnostic performances of MRI for diagnosis of lesions of uterosacral ligaments by correlating MRI's results with those of laparoscopy.
Time frame: 1 month
Correlate, a posteriori, MRI results with findings of laparoscopy and EHP 30 score evolution
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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. This study is not recruiting at the moment.
Thierry MICHY, MD principal investigator
University Hospital, Grenoble
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 Endometriosis, run by University Hospital, Grenoble 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre PITTET (+33 (0)4 76 76 68 72, ppittet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the quality of life of patients before and 3 months after laparoscopic treatment of isolated endometriosic lesions of uterosacral ligaments by French version of the EHP 30 questionnaire. (time frame: 3 months). 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 10 Mar 2020.