Radiological Diagnostics in Patients With Deep Endometriosis

NCT06799767 | Recruiting

• 1 other identifier: Endo-RAD
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Endometriosis

Keywords

deep endometriosis; radiological diagnostics; tractography; augmented reality; 3D-modelling; radiomics

Outcome Measures

Primary Outcomes (4)

• 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".

  During the first visit after enrollment

• 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

  During the first visit after enrollment

• 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

  During the first visit after enrollment

• 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

  During the first visit after enrollment

Secondary Outcomes (1)

• Diagnostics and the applicability of new MRI techniques: tractography

  During surgery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical and ultrasound diagnosis of deep endometriosis who are candidates for MRI for further diagnosis

You may qualify if:

• 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

You may not qualify if:

• 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
• Previous radiotherapy/chemotherapy
• Radiculopathy, herniated discs, spinal abnormalities and pathologies
• Laparotomic conversion during surgery

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Renato Seracchioli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Seracchioli, MD

CONTACT

+390512143944; renato.seracchioli@aosp.bo.it

Linda Bertoldo, MD

CONTACT

lindabertoldodrssa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 29, 2025
• Study Start: April 7, 2021
• Primary Completion: February 1, 2025
• Study Completion: April 30, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-11

Locations

IT (1)