EndometriosisULTRA-AAGLNCT05291624
Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification
An observational study of Endometriosis and Bowel Endometriosis, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis, Bowel Endometriosis, Deep Endometriosis
- What is being tested?
- AAGL Endometriosis Classification score - ULTRASOUND and AAGL Endometriosis Classification score - SURGERY
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation and subsequent surgical approach.
Who may be able to join
- patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Marcello Ceccaroni, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, VR, 37024
Marcello Ceccaroni, issaschool@gmail.com
Fabio Barra, fabio.barra@icloud.com
About this study
Official title: Concordance Between Ultrasonographic and Surgical Assessment in Patients With Endometriosis by Using AAGL 2021 Endometriosis Classification: a Single-center Prospective Study
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.
- Being tested
- AAGL Endometriosis Classification score - ULTRASOUND, AAGL Endometriosis Classification score - SURGERY
- Keywords
- Preoperative Ultrasound, Endometriosis staging, Surgical complexity
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAGL Endometriosis Classification score - ULTRASOUNDDiagnostic test
At baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification
AAGL Endometriosis Classification score - SURGERYDiagnostic test
Within 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification
| Study group | Role | What they receive |
|---|---|---|
| Patients with preoperative suspicion of endometriosis | Consecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis Receives: Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND; Diagnostic Test: AAGL Endometriosis Classification score - SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility between ultrasonographic and surgical AAGL staging (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)
Measured: 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)
Measured: 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
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291624
- Sponsor's protocol ID
- ULTRASOUND-AAGL2021
- Acronym
- ULTRA-AAGL
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34583009
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Ultrasonographic and Surgical Assessment in Patients With Endometriosis by Using AAGL 2021 Endometriosis Classification: a Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT05291624
- Acronym / sponsor ID
- ULTRA-AAGL / ULTRASOUND-AAGL2021
- Keywords
- Preoperative Ultrasound, Endometriosis staging, Surgical complexity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with preoperative suspicion of endometriosis | – | Diagnostic Test: AAGL Endometriosis Classification score - ULTRASOUND, Diagnostic Test: AAGL Endometriosis Classification score - SURGERYConsecutive patients undergoing ultrasonographic preoperative assessment and subsequent surgical approach for deep endometriosis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation and subsequent surgical approach.
Key inclusion criteria (1 listed)
- patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAGL Endometriosis Classification score - ULTRASOUNDAt baseline, ultrasonographic evaluation of patients by following AAGL Endometriosis Classification | Diagnostic test | Patients with preoperative suspicion of endometriosis |
| AAGL Endometriosis Classification score - SURGERYWithin 1 month from enrollment, surgical evaluation of patients by following AAGL Endometriosis Classification | Diagnostic test | Patients with preoperative suspicion of endometriosis |
Primary outcome
Reproducibility between ultrasonographic and surgical AAGL staging (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity)
Time frame: 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)
Time frame: Through study completion, an average of 1 month
1 secondary outcome
Comparison between ultrasonographic and surgical AAGL staging subdomains (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity) score
Time frame: Through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 34583009Abrao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello Ceccaroni, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Bowel Endometriosis, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Ferrero, MD, PhD (0039 010511525, simoneferrero@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility between ultrasonographic and surgical AAGL staging (minimum value: 0 points, maximum value: 111 points, higher scores mean a higher surgical complexity) (time frame: Through study completion, an average of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.