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

February 23, 2026 updated by: Casa di Cura Dott. Pederzoli

Ultrasound Diagnosis of Superficial Endometriosis of LUS (Uterosacral Ligaments): Definition of a Laparoscopically Validated Ultrasound Cut-off.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Napoli
      • Napoli, Napoli, Italy, 80131
        • Not yet recruiting
        • Policlinico Universitario Federico II
        • Contact:
          • Pierluigi Giampaolino, MD
    • Padova
    • Udine
      • Udine, Udine, Italy, 33100
        • Not yet recruiting
        • Presidio ospedaliero-universitario Santa Maria della Misericordia - Azienda Sanitaria Universitaria Friuli Centrale
        • Contact:
          • Giuseppe Vizielli, MD
    • Verona
      • Peschiera del Garda, Verona, Italy, 37019
        • Recruiting
        • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

the study is conducted in patients of childbearing age undergoing laparoscopic surgery for benign or malignant gynecological pathology in early stage. The study does not include changes to the standard care pathway. The indication for surgical treatment is given following the most up-to-date guidelines on the subject. Patients who are younger, postmenopausal, or have undergone previous pelvic surgery are excluded as these factors could alter the anatomy and ultrasound evaluation of LUS (uterosacral ligament).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic performance parameters
Time Frame: through study completion, an average of 1 year
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC), will be calculated by comparing ultrasound data with laparoscopic findings.
through study completion, an average of 1 year
measurement of of the thickness of the LUS (uterosacral ligaments)
Time Frame: through study completion, an average of 1 year
Three points (central, right and left) of measurement and calculation of the average between measurements. A ROC analysis (Receiver Operating Characteristic) will then be conducted to identify an optimal thickness cutoff value that can predict the presence of superficial endometriosis
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa di Cura Dott. Pederzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818CET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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