Radiological Diagnostics in Patients With Deep Endometriosis
ConditionDeep Endometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
Endometriosis is a benign, chronic, recurrent disease characterised by the presence of endometrial glands and stroma outside the uterine cavity. A non-negligible proportion of patients, 2-37%, are affected by deep endometriosis (DIE), defined as the pathology's involvement of the muscular tunic propria of the abdomino-pelvic organs.
From a therapeutic point of view, a medical or surgical approach is possible. The choice is influenced by several factors, such as the patient's age, reproductive desire, the extent of symptoms, the size and location of the endometriosis lesions, and the presence of organ damage. Although the surgical approach brings satisfactory results in terms of symptom reduction and improved fertility, the risk of complications can be very high, especially in the case of DIE, as bladder, rectal and sexual function can be compromised due to iatrogenic damage to the autonomic fibres that innervate the pelvic organs. Recently, the concept of 'nerve-sparing' surgery has been extended to gynaecology, and in particular to surgery for the treatment of endometriosis, showing encouraging results in terms of both symptom control and functional outcome.
In recent years, nuclear magnetic resonance imaging (NMR) has been increasingly helpful in the diagnosis of endometriosis and adenomyosis and is increasingly used in pre-operative planning.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical and ultrasound diagnosis of deep endometriosis, with or without ovarian endometriosis, with indication for MRI for further diagnosis and subsequent candidate for laparoscopic surgical treatment of the pathology
Age between 18 and 40 years
Obtaining informed consent
Disqualifiers
Previous abdominal surgery
Personal history of malignancy (current or previous)
Chronic inflammatory bowel disease (Crohn's disease, Ulcerative Rectocolitis, Indeterminate Colitis), interstitial cystitis
Personal history of Pelvic Inflammatory Disease (PID), active or previous
Trial population
Patients with a clinical and ultrasound diagnosis of deep endometriosis who are candidates for MRI for further diagnosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Diagnostics and the applicability of new MRI techniques: tractography
Assessing sacral plexus root abnormalities by DTI-RMN and analysing the correlation between DTI abnormalities and the presence and severity of typical endometriosis symptoms (chronic pelvic pain, dysmenorrhoea, dyspareunia, ovulatory pain, dyschezia and dysuria) through Numerical Rating Scale (NRS), that is 0 "no pain," 10 "worst pain imaginable".
Time frame
During the first visit after enrollment2
Diagnostic accuracy and applicability of new MRI techniques: augmented reality
Evaluate the diagnostic accuracy and precision of fiber tractography (FT) in reconstructing the course of the ureters bilaterally and mapping the hypogastric nerve bilaterally by comparing images obtained on MRI with in vivo surgical dissection
Time frame
During the first visit after enrollment3
Diagnostic accuracy and applicability of new MRI techniques: 3D-modelling
Evaluate the diagnostic accuracy of 3D models of endometriosis nodules of the rectum and sigma obtained by MRI
Time frame
During the first visit after enrollment4
Diagnostic accuracy and applicability of new MRI techniques: radiomics
Develop a pattern-recognition system based on MRI techniques for the histological nature (stromal vs. fibrotic) of the endometriosis nodules examined. Confirmation will be obtained on the basis of the definitive histological examination after surgery
Time frame
During the first visit after enrollmentSecondary outcomes
1
Diagnostics and the applicability of new MRI techniques: tractography
Assessing the correlation between DTI abnormalities and the location of endometriotic lesions found during surgery
Time frame
During surgerySponsors and contacts
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Source ClinicalTrials.gov