ENDOMETRIOSIS - MRI

Endometriosis Clinical Trial

— ENDO-MRI  

Official title:

Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis

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
• 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
• 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

Related Conditions & MeSH terms

• Comparative Study
• Diagnosis
• Endometriosis
• Magnetic Resonance Imaging
• Mobility Limitation
• Pelvis

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