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

Recruiting

• Conditions: Endometriosis

• Registration Number: NCT06017531
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

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.

Study Timeline

• Study Start: 2023-03-28
• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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
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

Trial Locations

Locations (1)

IRCCS Sacro Cuore Don Calabria di Negrar; 🇮🇹 Negrar, Verona, Italy