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

Last updated: August 24, 2023
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

N/A

Clinical Study ID

NCT06017531
2023-A
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinical suspicion of DE, for which a preoperative transvaginal ultrasonographicassessment 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

Exclusion Criteria:

  • previous surgical diagnosis of parametrial DE;
  • previous radiological diagnosis of parametrial DE including techniques used todiagnose DE (such as magnetic resonance [MRI], computed tomography-based virtualcolonoscopy [CTC] or double-contrast barium enema);
  • previous bilateral ovariectomy.

Study Design

Total Participants: 600
Study Start date:
March 28, 2023
Estimated Completion Date:
September 30, 2023

Study 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.

Connect with a study center

  • IRCCS Sacro Cuore Don Calabria di Negrar

    Negrar, Verona
    Italy

    Active - Recruiting

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