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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05779462
Other study ID # 2022_0032
Secondary ID 2022-A02135-38
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2023
Est. completion date December 2024

Study information

Verified date January 2023
Source University Hospital, Lille
Contact Chrystele RUBOD, MD,PhD
Phone 0320445962
Email chrystele.rubod@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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


Intervention

Other:
Dynamic MRI Sequence
Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI. Baseline
Secondary the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI. Baseline
Secondary 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
Secondary 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. 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.
Baseline
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