Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

NCT05291624 — Unknown, 500 participants, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

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

Registry	NCT05291624, acronym ULTRA-AAGL
Status	Unknown
Study type	Observational
Enrollment	500 (Estimated)
Sponsor	Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia (Other)
Conditions	Endometriosis, Bowel Endometriosis, Deep Endometriosis, Ovarian Endometrioma
Interventions	AAGL Endometriosis Classification score - ULTRASOUND, AAGL Endometriosis Classification score - SURGERY (Diagnostic test)
Dates	start 2022-04-01, primary completion 2022-12-31 (estimated), completion 2022-12-31 (estimated), first posted 2022-03-22, last updated 2022-09-21
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with preoperative suspicion of endometriosis		Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND; Diagnostic Test: AAGL Endometriosis Classification score - SURGERY	Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis

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

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: Female, ages: 18 Years to 55 Years

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.

+Locations (1)

Facility	City	Country	Status
Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria	Negrar, VR	Italy	Recruiting

+Publications

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. PMID 34583009