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

IRCCS Sacro Cuore Don Calabria di Negrar600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Endometriosis

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

RECRUITING

Outcomes

Primary Outcomes

Diagnostic accuracy

Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

Characteristics of parametrial DE

Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Preoperative exam