ULTRA-AAGL: Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with preoperative suspicion of endometriosis Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis |
Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND
At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification
Diagnostic Test: AAGL Endometriosis Classification score - SURGERY
Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Criteria
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;
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patients with previous bilateral ovariectomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | VR | Italy | 37024 |
Sponsors and Collaborators
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- ULTRASOUND-AAGL2021