Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific Area of the Pelvis (the Uterosacral Ligaments)
Recruiting · NCT07427849 · Observational (researchers observe without assigning treatment) · Lead sponsor: Casa di Cura Dott. Pederzoli
View the official record on ClinicalTrials.gov →Interventions studied
laparoscopic surgery for gynecological pathology
What this trial is about
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 take part
Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
4 locations listed.
- 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