Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single-center, prospective diagnostic-accuracy study. All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included. Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. Surgical and pathological data will be analyzed to confirm the presence of parametrial DE.
Detailed Description
This is a single-center, prospective diagnostic-accuracy study. All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included. Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. Surgical and pathological data will be analyzed to confirm the presence of parametrial DE. All the study procedures are done according to our clinical practice. Demographic and ultrasonographic data will be collected from the preoperative evaluation, which is routinely done at our institution by four ultrasonographic expert in diagnosing deep endometriosis. Surgical and pathological data will be collected during surgical procedures and hospital stay.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: Preoperative exam, surgical and/or histological confirmation
Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Sensitivity
Time Frame: Preoperative exam, surgical and/or histological confirmation
Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
negative predictive value
Time Frame: Preoperative exam, surgical and/or histological confirmation
of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Positive likelihood ratio
Time Frame: Preoperative exam, surgical and/or histological confirmation
Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Specificity
Time Frame: Preoperative exam, surgical and/or histological confirmation
Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Negative likelihood ratio
Time Frame: Preoperative exam, surgical and/or histological confirmation
Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
positive predictive value
Time Frame: Preoperative exam, surgical and/or histological confirmation
of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Secondary Outcomes
- Characteristics of parametrial DE(Preoperative exam)
- Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium)(Preoperative exam, surgical and/or histological confirmation)
- Other DE nodules and indirect DE signs(Preoperative exam)
- Infiltration of parametrial DE nodules(Preoperative exam, surgical and/or histological confirmation)