NCT05291624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

March 3, 2022

Last Update Submit

September 19, 2022

Conditions

EndometriosisBowel EndometriosisDeep EndometriosisOvarian Endometrioma

Keywords

Preoperative UltrasoundEndometriosis stagingSurgical complexity

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • 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

Study Arms (1)

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 - ULTRASOUNDDiagnostic Test: AAGL Endometriosis Classification score - SURGERY

Interventions

AAGL Endometriosis Classification score - ULTRASOUNDDIAGNOSTIC_TEST

At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification

Patients with preoperative suspicion of endometriosis
AAGL Endometriosis Classification score - SURGERYDIAGNOSTIC_TEST

Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification

Patients with preoperative suspicion of endometriosis

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation and subsequent surgical approach.

You may qualify if:

  • \- patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, VR, 37024, Italy

RECRUITING

Related Publications (1)

  • 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: 34583009BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Simone Ferrero, MD, PhD

CONTACT

0039 010511525simoneferrero@me.com

Marcello Ceccaroni, MD, PhD

CONTACT

issaschool@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 22, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

IT(1)