AzTrials
AzTrials

EndometriosisNCT06017531

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

An observational study of Endometriosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis
How many people
600 participants
Where
1 siteItaly
Study dates
28 Mar 2023to Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • IRCCS Sacro Cuore Don Calabria di Negrar

    Negrar, Verona

    Marcello Ceccaroni, Doctor, marcello.ceccaroni@sacrocuore.it

    0456013111

    Recruiting

Other trials in Italy

About this study

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.

Read the 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.

Conditions
Endometriosis
Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy

    Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

  2. Sensitivity

    Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

  3. Specificity

    Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

  4. positive predictive value

    of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

  5. negative predictive value

    of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

  6. Positive likelihood ratio

    Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

  7. Negative likelihood ratio

    Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Measured: Preoperative exam, surgical and/or histological confirmation

Secondary outcomes (4)

  1. Characteristics of parametrial DE

    Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound

    Measured: Preoperative exam

  2. 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.

    Measured: Preoperative exam, surgical and/or histological confirmation

  3. 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

    Measured: Preoperative exam, surgical and/or histological confirmation

  4. 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

    Measured: Preoperative exam

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start28 Mar 2023
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017531
Sponsor's protocol ID
2023-A
Status last verified
Aug 2023
First submitted
24 Aug 2023
Last updated
30 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Barra F, Zorzi C, Albanese M, De Mitri P, Stepniewska A, Roviglione G, Giani M, Albertini G, Ferrero S, Ceccaroni M. Ultrasonographic characterization of parametrial endometriosis: a prospective study. Fertil Steril. 2024 Jul;122(1):150-161. doi: 10.1016/j.fertnstert.2024.02.031. Epub 2024 Feb 19.

    PubMed 38382700

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy (time frame: Preoperative exam, surgical and/or histological confirmation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in