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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06017531
Other study ID # 2023-A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 28, 2023
Est. completion date September 2023

Study information

Verified date August 2023
Source IRCCS Sacro Cuore Don Calabria di Negrar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Sacro Cuore Don Calabria di Negrar Negrar Verona

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Characteristics of parametrial DE Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound Preoperative exam
Secondary 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
Secondary 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
Secondary 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
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