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

NCT07427849 | Recruiting DMC

• 1 other identifier: 818CET
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Endometriosis (Diagnosis)

Keywords

ultrasound; gynecology; laparoscopic surgery; uterosacral ligaments

Outcome Measures

Primary Outcomes (2)

• measurement of of the thickness of the LUS (uterosacral ligaments)

  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

• diagnostic performance parameters

  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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead

Study Sites (4)

Policlinico Universitario Federico II

Naples, Napoli, 80131, Italy

NOT YET RECRUITING

Policlinico Abano Terme

Abano Terme, Padova, 35031, Italy

NOT YET RECRUITING

Presidio ospedaliero-universitario Santa Maria della Misericordia - Azienda Sanitaria Universitaria Friuli Centrale

Udine, Udine, 33100, Italy

NOT YET RECRUITING

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis; Disease

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)