NCT03981991

Endometriosis and Quality of Life Assessed by EHP 30

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Endometriosis

Timeline

• Start date: 2019-07-31
• Primary completion: 2020-11-01
• Completion: 2021-06-01
• First posted: 2019-06-11
• Last updated: 2020-03-10

Locations

1 site across 1 country: France