Clinical trial NCT05291624: Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification
Official title: Concordance Between Ultrasonographic and Surgical Assessment in Patients With Endometriosis by Using AAGL 2021 Endometriosis Classification: a Single-center Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Bowel Endometriosis
Deep Endometriosis
Ovarian Endometrioma
Keywords: Preoperative Ultrasound
Endometriosis staging
Surgical complexity
Lead sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation and subsequent surgical approach.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reproducibility between ultrasonographic and surgical AAGL staging (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)
timeFrame: Through study completion, an average of 1 month
measure: Comparison between total ultrasonographic and surgical AAGL staging score (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Comparison between ultrasonographic and surgical AAGL staging subdomains (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity) score
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria
state: VR
Study officials:
References:
citation: 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.