Clinical trial NCT06017531: Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)
Official title: Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: Sensitivity
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: Specificity
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: positive predictive value
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: negative predictive value
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: Positive likelihood ratio
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: Negative likelihood ratio
timeFrame: Preoperative exam, surgical and/or histological confirmation
Secondary outcomes:
measure: Characteristics of parametrial DE
timeFrame: Preoperative exam
measure: Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium)
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: Infiltration of parametrial DE nodules
timeFrame: Preoperative exam, surgical and/or histological confirmation
measure: Other DE nodules and indirect DE signs
timeFrame: Preoperative exam
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria di Negrar
state: Verona
Study officials:
References: