Ultrasound evaluation of lesions in deep endometriosis
Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)
This study is testing how well ultrasound can find deep endometriosis lesions in women before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT06017531 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of ultrasound in identifying parametrial lesions in women with deep endometriosis (DE) prior to surgery. Over a six-month period, women suspected of having DE will undergo preoperative ultrasound evaluations, and their clinical and ultrasound data will be collected. Surgical and pathological findings will then be analyzed to confirm the presence of parametrial DE, providing insights into the effectiveness of ultrasound as a diagnostic tool.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a clinical suspicion of deep endometriosis requiring surgical intervention.
Not a fit: Patients who have previously been diagnosed with parametrial deep endometriosis or have undergone bilateral ovariectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing deep endometriosis, leading to better treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using ultrasound for diagnosing endometriosis, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical suspicion of DE, for which a preoperative transvaginal ultrasonographic assessment and laparoscopic surgical approach will be indicated; * age \> or equal to 18 years * informed consent for the participation in the study and for personal data treatment. Exclusion Criteria: * previous surgical diagnosis of parametrial DE; * previous radiological diagnosis of parametrial DE including techniques used to diagnose DE (such as magnetic resonance \[MRI\], computed tomography-based virtual colonoscopy \[CTC\] or double-contrast barium enema); * previous bilateral ovariectomy.
Where this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria di Negrar — Negrar, 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.