Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy [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 [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.
- Specificity [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.
- positive predictive value [Preoperative exam, surgical and/or histological confirmation]
of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
- negative predictive value [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 [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.
- Negative likelihood ratio [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.
Secondary Outcome Measures
- Characteristics of parametrial DE [Preoperative exam]
Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound
- Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium) [Preoperative exam, surgical and/or histological confirmation]
Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of transvaginal ultrasound for distinguishing the intraoperative presence of parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium) with surgical and/or histological confirmation.
- Infiltration of parametrial DE nodules [Preoperative exam, surgical and/or histological confirmation]
Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative infiltration of parametrial DE nodules in other pelvic structures (i.e. rectosigmoid, uterosacral ligaments) with surgical and/or histological confirmation
- Other DE nodules and indirect DE signs [Preoperative exam]
Prevalence of other DE nodules and indirect DE signs in patients in the case of evidence of parametrial DE at preoperative ultrasound
Eligibility Criteria
Criteria
Inclusion Criteria:
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clinical suspicion of DE, for which a preoperative transvaginal ultrasonographic assessment and laparoscopic surgical approach will be indicated;
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age > or equal to 18 years
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informed consent for the participation in the study and for personal data treatment.
Exclusion Criteria:
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previous surgical diagnosis of parametrial DE;
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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);
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previous bilateral ovariectomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Sacro Cuore Don Calabria di Negrar | Negrar | Verona | Italy |
Sponsors and Collaborators
- IRCCS Sacro Cuore Don Calabria di Negrar
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-A