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Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05291624
Acronym
ULTRA-AAGL
Enrollment
500
Registered
2022-03-22
Start date
2022-04-01
Completion date
2022-12-31
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Endometriosis, Deep Endometriosis, Endometriosis, Ovarian Endometrioma

Keywords

Preoperative Ultrasound, Endometriosis staging, Surgical complexity

Brief summary

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.

Interventions

DIAGNOSTIC_TESTAAGL Endometriosis Classification score - ULTRASOUND

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

DIAGNOSTIC_TESTAAGL Endometriosis Classification score - SURGERY

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

Sponsors

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Reproducibility between ultrasonographic and surgical AAGL staging (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)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)Through study completion, an average of 1 month

Secondary

MeasureTime frame
Comparison between ultrasonographic and surgical AAGL staging subdomains (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity) scoreThrough study completion, an average of 1 month

Countries

Italy

Contacts

Primary ContactSimone Ferrero, MD, PhD
simoneferrero@me.com0039 010511525
Backup ContactMarcello Ceccaroni, MD, PhD
issaschool@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026