Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

Recruiting

• Conditions: Endometriosis; Bowel Endometriosis; Deep Endometriosis; Ovarian Endometrioma
• Interventions: Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND; Diagnostic Test: AAGL Endometriosis Classification score - SURGERY

• Registration Number: NCT05291624
• Lead Sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-12
• Study First Posted: 2022-03-22
• Study Start: 2022-04-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with preoperative suspicion of endometriosis	AAGL Endometriosis Classification score - SURGERY	Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis
Patients with preoperative suspicion of endometriosis	AAGL Endometriosis Classification score - ULTRASOUND	Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria; 🇮🇹 Negrar, VR, Italy