IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
Location contact
Linda Bertoldo, MD
CONTACT
Renato Seracchioli, MD
CONTACT
Renato Seracchioli, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06799767
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.
Interested in participating?
Request Info18 year–40 year
Female
Observational
Bologna, 40138, Italy
Location status: Recruiting
Linda Bertoldo, MD
CONTACT
Renato Seracchioli, MD
CONTACT
Renato Seracchioli, MD
PRINCIPAL_INVESTIGATOR
Endometriosis is a benign, chronic, recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Although most frequently localised at the ovarian level (17 - 44%), a proportion of 2-37% of patients are affected by deep endometriosis (DIE), which involves the muscular tunic propria of the abdomino-pelvic organs. The most commonly affected sites are the rectovaginal septum, utero-sacral ligaments, rectum and sigma, ureters, parameters, hypogastric nerves, bladder and pre-vesical peritoneum.
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 together with transvaginal and/or transabdominal ultrasound. Recently, new techniques have been developed, such as Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI) and Dynamic Contrast Enhanced (DCE), whose gynaecological applications are currently in their infancy.
The study aims to evaluate the diagnostic accuracy and applicability of new MRI techniques in patients with deep endometriosis and candidates for surgical treatment.
In particular, the techniques that the investigators intend to investigate are: augmented reality, tractography, 3D-modelling, radiomics.
The use of these innovative methods, based on MRI techniques, may make it possible not only to plan an even more personalised treatment approach, selecting patients who could benefit from different treatments (such as presacral neurectomy, nerve root infiltration neurostimulation and the use of effective analgesics for neuropathic pain), but also to facilitate the localisation of endometriotic lesions during laparoscopic surgery, allowing the surgeon to assess their relationship with the main nerve and vascular structures of the pelvis and increasingly facilitating the nerve-sparing approach.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During the first visit after enrollment
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 enrollment
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 enrollment
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 enrollment
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 surgery
Assessing the correlation between DTI abnormalities and the location of endometriotic lesions found during surgery
Contact information is provided by the study sponsor or research team.
Linda Bertoldo, MD
CONTACT
Renato Seracchioli, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Implementation Of Radiological Diagnostics In Patients With Deep Endometriosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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