Image

Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific Area of the Pelvis (the Uterosacral Ligaments)

Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific Area of the Pelvis (the Uterosacral Ligaments)

Recruiting
18-50 years
Female
Phase N/A

Powered by AI

Overview

An observational, prospective, multicenter study conducted on patients of childbearing age undergoing laparoscopic surgery for early-stage benign or malignant gynecological disease. The study does not include changes to the standard care pathway.

Description

All patients enrolled in the study will undergo a level II gynecological ultrasound with a transvaginal approach.

The uterosacral ligaments will be identified ultrasound-wise at the level of the cervix in a transverse scan, in line with the scanning techniques described in the literature. The first measurement point will be located in the median area, at the level of the torus uterinus; the further two measurements will be taken at the level of the LUS (uterosacral ligaments) 1.5 cm to the right and 1.5 cm to the left with respect to the torus. For each patient, the three measurements will be recorded and the average of the values obtained will be calculated, considered as a parameter representative of the average thickness of the LUS (uterosacral ligaments). The acquired ultrasound images will be archived as per clinical practice.

Subsequently, patients will undergo laparoscopic surgery. During the procedure, the presence or absence of superficial endometriosis lesions of the LUS will be documented, as well as the presence of any other locations of deep and superficial disease, according to a predefined grid.

Finally, ultrasound and laparoscopic data will be compared to assess diagnostic concordance at the site of primary interest (LUS), with particular reference to ultrasound thickness as a possible indicator of the presence of laparoscopically confirmed superficial endometriosis.

Eligibility

Inclusion Criteria:

  • patients who need to undergo gynecological surgery with a laparoscopic approach for benign pathology (endometriosis, uterine fibroids, adenomyosis, chronic pelvic pain, benign ovarian cysts) or non-advanced malignant pathology (stage I endometrium and cervix, stage I and II ovary).
  • patients who performed a level II gynecological ultrasound with an experienced operator in the preoperative pathway.
  • technical possibility of performing a transvaginal ultrasound and the patient's willingness to undergo such an investigation.
  • patients of childbearing age (18 - 50 years).
  • Signing of informed consent.

Exclusion Criteria:

  • presence of endometriosis deeply infiltrating the posterior compartment. This may interfere with the interpretation of uterosacral ligament (LUS) thickness as a specific marker of superficial endometriosis
  • technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
  • incomplete ultrasound evaluation of the uterosacral ligaments for anatomical reasons or for the presence of endometriosis nodules from other sites with partial involvement of the LUS (uterosacral ligament).
  • advanced malignant disease (\>Stage I for endometrium and cervix, \> Stage II for ovary)
  • pelvic organ prolapse
  • PID or other pelvic inflammatory diseases
  • medical emergencies (ovarian torsion, hemoperitoneum)
  • postmenopausal patients
  • previous pelvic surgery

Study details
    Endometriosis (Diagnosis)

NCT07427849

Casa di Cura Dott. Pederzoli

15 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.