Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific… (NCT07427849) | Clinical Trial Compass
RecruitingNot Applicable
Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific Area of the Pelvis (the Uterosacral Ligaments)
Italy64 participantsStarted 2026-02-17
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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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
What they're measuring
1
measurement of of the thickness of the LUS (uterosacral ligaments)
Timeframe: through study completion, an average of 1 year
2
diagnostic performance parameters
Timeframe: through study completion, an average of 1 year