Endometriosis and Quality of Life Assessed by EHP 30 (ENDOLUS)

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Pierre PITTET; Phone Number: +33 (0)4 76 76 68 72; Email: ppittet@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • University Hospital Grenoble
    • Contact: Pierre PITTET; Phone Number: +33 (0)4 76 76 68 72; Email: ppittet@chu-grenoble.fr
    • Contact: Thierry MICHY, MD; Phone Number: +33 (0)4 76 76 66 77; Email: tmichy@chu-grenoble.fr
    • Principal Investigator: Thierry MICHY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Patient aged from 18 to 50 years
2. Patient with medical sign proving endometriotic lesion: dysmenorrhea, deep dyspareunia or chronic pelvic pain
3. Patient with standardized pelvic MRI realized at CHUGA
4. Patient with an indication for laparoscopic surgical treatment
5. Patient available to complete the questionnaire based on EHP 30
6. Patient available for a follow-up of 6 months
7. Patient able to understand and read French language
8. Patient affiliated to a social security system or beneficiary of the same.
9. Patient who agreed to participate to the research

Exclusion Criteria:

1. Patient with functional urinary or digestive signs related to endometriotic lesion
2. Patient with another deep lesion proved by MRI: endometrioma, rectovaginal septum, recto-sigmoid, urinary bladder, ureters, recto-uterine pouch.
3. Virgin patient
4. Patient with a contraindication to MRI
5. History of extensive pelvic surgery related to endometriosis
6. Pregnancy
7. Patient who did not receive laparoscopic treatment of uterosacral ligaments
8. Patient already involved in another clinical research study
9. Patient in a period of exclusion from another clinical research study
10. 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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Thierry MICHY, MD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Endometriosis; EHP 30; Uterosacral Ligament
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 38RC19.130; 2019-A01143-54 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No