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
Study 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
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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
Primary outcome measure(s)
measurement of of the thickness of the LUS (uterosacral ligaments) — through study completion, an average of 1 year 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
diagnostic performance parameters — through study completion, an average of 1 year Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC), will be calculated by comparing ultrasound data with laparoscopic findings.
Trial sites (4)
Facility
City
Region
Status
Policlinico Universitario Federico II
Naples
Napoli
Not Yet Recruiting
Policlinico Abano Terme
Abano Terme
Padova
Not Yet Recruiting
Presidio ospedaliero-universitario Santa Maria della Misericordia - Azienda Sanitaria Universitaria Friuli Centrale
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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