Endometriosis Clinical Trial
— ENDOLUSOfficial 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2021 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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