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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: Endometriosis

Study type: Observational

Funder types: Other

Identifiers

NCT06017531

2023-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.