RecruitingNCT07427849

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.


Sponsor

Casa di Cura Dott. Pederzoli

Enrollment

64 participants

Start Date

Feb 17, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

OTHERlaparoscopic 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


Locations(4)

Policlinico Universitario Federico II

Naples, Napoli, Italy

Policlinico Abano Terme

Abano Terme, Padova, Italy

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

Udine, Udine, Italy

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

Peschiera del Garda, Verona, Italy

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NCT07427849


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