ENDOMETRIOSIS - MRI

Not yet recruiting

• Conditions: Magnetic Resonance Imaging; Diagnosis; Pelvis; Endometriosis; Mobility Limitation; Comparative Study
• Interventions: Other: Dynamic MRI Sequence

• Registration Number: NCT05779462
• Lead Sponsor: University Hospital, Lille

Brief Summary

Endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age. There is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult. It therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented. The clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively. The persistence of hypo-mobility could also help to understand treatment failures.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22
• Study Start: 2023-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Patient referred for suspected pelvic endometriosis requiring pelvic MRI
• Female, nulliparous,
• patient with signed written consent, patient with health insurance,
• patient willing to comply with all study procedures and duration

Exclusion Criteria

• BMI > 35,
• history of hereditary collagen and elastic tissue disease,
• history of pelviperitonitis,
• history of major pelvic surgery,
• inability to receive informed information,
• inability to participate in the entire study,
• lack of social security coverage,
• refusal to sign consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with pelvic endometriosis	Dynamic MRI Sequence	Patients referred for suspected pelvic endometriosis, with pelvic endometriosis on initial MRI
patients without pelvic endometriosis	Dynamic MRI Sequence	Patients referred for suspected pelvic endometriosis but without endometriosis found on diagnostic MRI.

Primary Outcome Measures

Name	Time	Method
the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI	Baseline

Secondary Outcome Measures

Name	Time	Method
the statistical association between the symptoms of patients with endometriosis and the mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort during dynamic MRI.	Baseline	Initial symptoms are associated with initial dynamic MRI data and post therapeutic symptoms are associated with post-therapeutic dynamic MRI data.; The symptoms of interest are dysmenorrhea, non-cyclic pelvic pain, dysuria, dychesia, transit disorders (diarrhea/constipation), and dyspareunia.
the measurement of variation in mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort between the initial dynamic MRI of patients with	Baseline
the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.	Baseline
the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI.	Baseline