Radiological Diagnostics in Patients With Deep Endometriosis

Recruiting now

Conditions studied: Deep Endometriosis

In brief

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.

Key facts

Study ID

NCT06799767

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

94

Starts

2021-04-07

Expected to finish

2025-04-30

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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