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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017531
• Other study ID #: 2023-A
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Endometriosis

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