Ultrasound Features of Endometriosis of the Uterosacral Ligaments

NCT ID: NCT06787352

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2025-12-31

Brief Summary

Ultrasound features most indicative of endometriosis of the uterosacral ligaments, which connect the cervix to the sacrum and are part of the uterus support structures, and verify the actual presence of endometriosis of these ligaments during surgery

Detailed Description

It is estimated that 1 in 10 women of childbearing age is affected by endometriosis. Objective examination alone is not sufficient to frame the pathology as the anatomic-clinical correspondence is relatively low: symptoms are not lesion specific and there may be asymptomatic women with pictures of severe endometriosis. Accurate diagnosis of all endometriosis by transvaginal ultrasound at the preoperative stage is therefore essential to discriminate patients who need surgery from those who can benefit from medical therapy alone, but also to be able to select a surgeon with adequate experience for this type of surgery. In recent years, moreover, it has been highlighted that ureteral endometriosis is associated with ipsilateral LUS injury. Ureteral damage has a nuanced symptomatology and cases in which the patient manifests signs and symptoms suggestive of renal resentment are rare (flank pain, renal colic, hypertension). Ureteral involvement can therefore lead to a silent loss of renal function, which in some cases requires nephrectomy. Several studies have already shown that there is a correlation between ureteral endometriosis and uterosacral ligaments (LUS) endometriosis, and that the likelihood of ureteral involvement increases with increasing nodule size. In light of this evidence and in order to improve the diagnostic power of the ultrasound method, it is therefore important to find the best combination of ultrasound parameters to predict endometriosis in LUS with sufficient accuracy.

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Study group

Endometriosis patients with diseased LUS

No interventions assigned to this group

Control group

Endometriosis patients with healthy LUS

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery;
• Age between 18 and 50 years;
• Signature of informed consent to the study

Exclusion Criteria

• Post-menopausal women (spontaneous or iatrogenic);
• Virgo patients;
• Hysterectomised patients;
• Pregnant patients;
• Patients undergoing pelvic/vaginal radiotherapy;
• Previous LUS surgery;
• Clinical diagnosis of pelvic organ prolapse;
• Preoperative ultrasound more than 60 days prior to surgery;
• Failure at surgery and any subsequent histopathological examination to find pelvic endometriosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego Raimondo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Azienda Ospedaliera Universitaria Senese

Siena, Siena, Italy

Countries

Italy

Other Identifiers

LUS2022

Identifier Type: -

Identifier Source: org_study_id