Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification (ULTRA-AAGL)

September 19, 2022 updated by: Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Concordance Between Ultrasonographic and Surgical Assessment in Patients With Endometriosis by Using AAGL 2021 Endometriosis Classification: a Single-center Prospective Study

In 2021, an international consensus developed a new endometriosis classification system, called AAGL 2021 Endometriosis Classification, for scoring intraoperative surgical complexity and to examine its correlation with patient-reported pain and infertility. Until now, no study has investigated the role of AAGL 2021 Endometriosis Classification in ultrasonographic assessment of patient with endometriosis. This study aims to compare the use of the AAGL 2021 Endometriosis Classification in preoperative (at ultrasound) and intraoperative (at surgery) evaluation of patients with endometriosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation and subsequent surgical approach.

Description

Inclusion Criteria:

- patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation.

Exclusion Criteria:

  • patients with suspected or diagnosed malignancy;
  • patients a history of colorectal surgery or a surgery for endometriosis including vaginal resection, full-thickness bowel resection or excision of a endometriotic lesion of the urinary bladder;
  • patients with previous bilateral ovariectomy.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with preoperative suspicion of endometriosis
Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis
Diagnostic test: AAGL Endometriosis Classification score - ULTRASOUND
At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification
Diagnostic test: AAGL Endometriosis Classification score - SURGERY
Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reproducibility between ultrasonographic and surgical AAGL staging (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month
Comparison between total ultrasonographic and surgical AAGL staging score (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison between ultrasonographic and surgical AAGL staging subdomains (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity) score
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month

Collaborators and Investigators

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

Sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

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)

April 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULTRASOUND-AAGL2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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