Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

Study Overview
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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.

Official Title
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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

Conditions
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Endometriosis, Bowel Endometriosis, Deep Endometriosis, Ovarian Endometrioma

Intervention / Treatment
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* Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND
* Diagnostic Test: AAGL Endometriosis Classification score - SURGERY


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with preoperative suspicion of endometriosis<br>Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis | Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND<br>* At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification<br>Diagnostic Test: AAGL Endometriosis Classification score - SURGERY<br>* Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Ultrasound, Endometriosis staging, Surgical complexity