Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

NCT ID: NCT05291624

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis Bowel Endometriosis Deep Endometriosis Ovarian Endometrioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with preoperative suspicion of endometriosis

Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis

AAGL Endometriosis Classification score - ULTRASOUND

Intervention Type DIAGNOSTIC_TEST

At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification

AAGL Endometriosis Classification score - SURGERY

Intervention Type DIAGNOSTIC_TEST

Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification

Interventions

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AAGL Endometriosis Classification score - ULTRASOUND

At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification

Intervention Type DIAGNOSTIC_TEST

AAGL Endometriosis Classification score - SURGERY

Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

OTHER

Sponsor Role lead

Responsible Party

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Simone Ferrero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, VR, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Simone Ferrero, MD, PhD

Role: CONTACT

0039 010511525

Marcello Ceccaroni, MD, PhD

Role: CONTACT

Facility Contacts

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Marcello Ceccaroni

Role: primary

Fabio Barra

Role: backup

References

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Abrao MS, Andres MP, Miller CE, Gingold JA, Rius M, Neto JS, Carmona F. AAGL 2021 Endometriosis Classification: An Anatomy-based Surgical Complexity Score. J Minim Invasive Gynecol. 2021 Nov;28(11):1941-1950.e1. doi: 10.1016/j.jmig.2021.09.709. Epub 2021 Sep 25.

Reference Type BACKGROUND
PMID: 34583009 (View on PubMed)

Other Identifiers

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ULTRASOUND-AAGL2021

Identifier Type: -

Identifier Source: org_study_id

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