Ultrasound detection of superficial endometriosis on the uterosacral ligaments
Ultrasound Diagnosis of Superficial Endometriosis of LUS (Uterosacral Ligaments): Definition of a Laparoscopically Validated Ultrasound Cut-off.
The team will try to see if measuring uterosacral ligament thickness with a transvaginal ultrasound can detect superficial endometriosis in people aged 18–50 scheduled for laparoscopic gynecologic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Casa di Cura Dott. Pederzoli Academic / other |
| Locations | 4 sites (Naples, Napoli and 3 other locations) |
| Trial ID | NCT07427849 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational study in patients of childbearing age undergoing planned laparoscopic surgery for benign or early-stage malignant gynecologic conditions. Before surgery, participants will have a level II transvaginal ultrasound where three standardized thickness measurements of the uterosacral ligaments are taken and averaged, with images archived. During laparoscopic surgery, the presence or absence of superficial endometriosis at the uterosacral ligaments and other pelvic sites will be documented using a predefined grid. Ultrasound and laparoscopic findings will be compared to see if ligament thickness correlates with laparoscopically confirmed superficial endometriosis, with no changes to standard clinical care.
Who should consider this trial
Good fit: People aged 18–50 who are scheduled for laparoscopic surgery for benign or early-stage gynecologic disease, can undergo transvaginal ultrasound, and are willing to consent are ideal candidates.
Not a fit: Patients with deeply infiltrating posterior compartment endometriosis, those unable or unwilling to have a transvaginal ultrasound, or those outside the 18–50 age range are unlikely to benefit from this specific diagnostic comparison.
Why it matters
Potential benefit: If successful, this approach could allow noninvasive preoperative detection of superficial endometriosis at the uterosacral ligaments, improving surgical planning and reducing diagnostic uncertainty.
How similar studies have performed: Previous ultrasound research has detected various endometriosis lesions, but using averaged uterosacral ligament thickness as a site-specific marker for superficial disease is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Naples, Napoli and 3 other locations
- Policlinico Universitario Federico II — Naples, Napoli, Italy (Not_yet_recruiting)
- Policlinico Abano Terme — Abano Terme, Padova, Italy (Not_yet_recruiting)
- Presidio ospedaliero-universitario Santa Maria della Misericordia - Azienda Sanitaria Universitaria Friuli Centrale — Udine, Udine, Italy (Not_yet_recruiting)
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda, Verona, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.