Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

Endometriosis Clinical Trial

— ULTRA-AAGL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291624
• Other study ID #: ULTRASOUND-AAGL2021
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Contact: Simone Ferrero, MD, PhD
• Phone: 0039 010511525
• Email: simoneferrero[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Endometriosis
• Deep Endometriosis
• Endometriosis
• Ovarian Endometrioma

Intervention

Diagnostic Test:
• AAGL Endometriosis Classification score - ULTRASOUND
At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification
• AAGL Endometriosis Classification score - SURGERY
Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification

Locations

Country	Name	City	State
Italy	Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria	Negrar	VR

Sponsors (1)

Lead Sponsor	Collaborator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

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