Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)

Conditions
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Endometriosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 
| Sensitivity | Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 
| Specificity | Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 
| positive predictive value | of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 
| negative predictive value | of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 
| Positive likelihood ratio | Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 
| Negative likelihood ratio | Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation. | Preoperative exam, surgical and/or histological confirmation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of parametrial DE | Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound | Preoperative exam | 
| Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium) | 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. | Preoperative exam, surgical and/or histological confirmation | 
| Infiltration of parametrial DE nodules | 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 | Preoperative exam, surgical and/or histological confirmation | 
| Other DE nodules and indirect DE signs | Prevalence of other DE nodules and indirect DE signs in patients in the case of evidence of parametrial DE at preoperative ultrasound | Preoperative exam |