Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis

October 29, 2022 updated by: Simone Ferrero

Indirect Ultrasonographic Findings Predicting Parametrial Involvement in Severe Deep Endometriosis

This study evaluated the use of ultrasonographic findings as a first-line imaging tool to raise indirect suspicion of parametrial involvement in women suspected of having severe endometriosis (DE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ultrasonographic findings will be conventionally divided in:

  • concomitant DE nodules
  • indirect DE signs

Study Type

Observational

Enrollment (Actual)

1078

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VR
      • Negrar, VR, Italy, 37024
        • Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected deep endometriosis undergoing surgical approach in a third-level referral center for endometriosis between January 2021 and December 2021

Description

Inclusion Criteria:

  • patients with suspected deep endometriosis undergoing surgical approach

Exclusion Criteria:

  • patients with a previous surgical diagnosis of endometriosis
  • pazients with radiological evidence of parametrial endometriosis
  • patients who could not undergo transvaginal and/or transabdominal ultrasound for any technical reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with surgical diagnosis of parametrial endometriosis
This cohort will include patients with surgical diagnosis of parametrial endometriosis
Diagnostic test: Ultrasound
Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.
Women without surgical diagnosis of parametrial endometriosis
This cohort will include patients without surgical diagnosis of parametrial endometriosis
Diagnostic test: Ultrasound
Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with a surgical diagnosis of parametrial endometriosis
Time Frame: At surgery
At surgery
Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement
Time Frame: 1 week before surgical approach
1 week before surgical approach
Number of significant ultrasonographic indirect DE signs predicting surgical involvement
Time Frame: 1 week before surgical approach
1 week before surgical approach

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simone Ferrero

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 29, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULTRA-PARAMETRENDO I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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