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NCT Number: NCT07427849

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Policlinico Universitario Federico II, Naples, Napoli, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic surgery for gynecological pathology

Other

Patients will be operated on by operators experienced in complex endometriotic surgery.

Ultrasound and laparoscopic data will be compared regarding the site of interest for the study, the LUS.

LUS thickness data will be recorded as a continuous variable in mm. The uterosacral ligaments (LUS) will be identified at the level of the cervix in a transverse scan, rotated by 45 °, according to the method described in the literature. At this site, LUS present as hyperechoic striae located posterior to the cervix. The first measurement will be performed at the level of the uterine torus, in the median position. This will be the reference point for subsequent measurements. Two further measurements will be taken, one on each side: one point will be located on the LUS 1.5 cm to the right and another 1.5 cm to the left of the torus uterinum. For each patient, the three measurements will be recorded and the average of the three measurements will be calculated as an additional parameter

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Casa di Cura Dott. Pederzoli

Other

Registry information

Official study title

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

Acronym: LUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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