Clinical trial NCT05779462: ENDOMETRIOSIS - MRI
Official title: Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Mobility Limitation
Magnetic Resonance Imaging
Diagnosis
Pelvis
Comparative Study
Keywords: Endometriosis ;
Mobility Limitation
Magnetic Resonance Imaging, Cine
Pelvis
Comparative Study
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population concerns patients referred to the Lille University Hospital for suspected pelvic endometriosis

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.


Eligibility criteria: 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

Primary outcomes:
measure: the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI
timeFrame: Baseline
Secondary outcomes:
measure: the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.
timeFrame: Baseline
measure: the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI.
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Chrystele RUBOD, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: