NCT07427849

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 64 (estimated)
• Sponsor: Casa di Cura Dott. Pederzoli · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Endometriosis (Diagnosis)

Interventions

Type	Name	Description
OTHER	laparoscopic surgery for gynecological pathology	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

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-02-23
• Last updated: 2026-02-25

Locations

4 sites across 1 country: Italy