EndometriosisNCT05239871
Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis
An observational study of Endometriosis and Deep Endometriosis, run by Simone Ferrero at 1 site in Italy.
Trial summary
This study evaluated the use of ultrasonographic findings as a first-line imaging tool to raise indirect suspicion of parametrial involvement in women suspected of having severe endometriosis (DE). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Deep Endometriosis
- What is being tested?
- Ultrasound
- How many people
- 1,078 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 1 Sep 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with suspected deep endometriosis undergoing surgical approach in a third-level referral center for endometriosis between January 2021 and December 2021
Who may be able to join
- patients with suspected deep endometriosis undergoing surgical approach
Who cannot join
- patients with a previous surgical diagnosis of endometriosis
- pazients with radiological evidence of parametrial endometriosis
- patients who could not undergo transvaginal and/or transabdominal ultrasound for any technical reason
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ginecologia - IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, VR, 37024
About this study
Official title: Indirect Ultrasonographic Findings Predicting Parametrial Involvement in Severe Deep Endometriosis
This study evaluated the use of ultrasonographic findings as a first-line imaging tool to raise indirect suspicion of parametrial involvement in women suspected of having severe endometriosis (DE).
Read the detailed description
Ultrasonographic findings will be conventionally divided in:
- concomitant DE nodules
- indirect DE signs
- Conditions
- Endometriosis, Deep Endometriosis
- Being tested
- Ultrasound
- Keywords
- Parametrial endometriosis, Deep endometriosis, Transvaginal Ultrasound
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Preoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria.
| Study group | Role | What they receive |
|---|---|---|
| Women with surgical diagnosis of parametrial endometriosis | This cohort will include patients with surgical diagnosis of parametrial endometriosis Receives: Diagnostic Test: Ultrasound | |
| Women without surgical diagnosis of parametrial endometriosis | This cohort will include patients without surgical diagnosis of parametrial endometriosis Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a surgical diagnosis of parametrial endometriosis
Measured: At surgery
Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement
Measured: 1 week before surgical approach
Number of significant ultrasonographic indirect DE signs predicting surgical involvement
Measured: 1 week before surgical approach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Mar 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simone Ferrero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239871
- Sponsor's protocol ID
- ULTRA-PARAMETRENDO I
- Status last verified
- Oct 2022
- First submitted
- 4 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guerriero S, Martinez L, Gomez I, Pascual MA, Ajossa S, Pagliuca M, Alcazar JL. Diagnostic accuracy of transvaginal sonography for detecting parametrial involvement in women with deep endometriosis: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2021 Nov;58(5):669-676. doi: 10.1002/uog.23754.
PubMed 34358386Mabrouk M, Raimondo D, Arena A, Iodice R, Altieri M, Sutherland N, Salucci P, Moro E, Seracchioli R. Parametrial Endometriosis: The Occult Condition that Makes the Hard Harder. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):871-876. doi: 10.1016/j.jmig.2018.08.022. Epub 2018 Aug 31.
PubMed 30176361Ceccaroni M, Clarizia R, Roviglione G. Nerve-sparing Surgery for Deep Infiltrating Endometriosis: Laparoscopic Eradication of Deep Infiltrating Endometriosis with Rectal and Parametrial Resection According to the Negrar Method. J Minim Invasive Gynecol. 2020 Feb;27(2):263-264. doi: 10.1016/j.jmig.2019.09.002. Epub 2019 Sep 10.
PubMed 31518711Guerriero S, Condous G, van den Bosch T, Valentin L, Leone FP, Van Schoubroeck D, Exacoustos C, Installe AJ, Martins WP, Abrao MS, Hudelist G, Bazot M, Alcazar JL, Goncalves MO, Pascual MA, Ajossa S, Savelli L, Dunham R, Reid S, Menakaya U, Bourne T, Ferrero S, Leon M, Bignardi T, Holland T, Jurkovic D, Benacerraf B, Osuga Y, Somigliana E, Timmerman D. Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms, definitions and measurements: a consensus opinion from the International Deep Endometriosis Analysis (IDEA) group. Ultrasound Obstet Gynecol. 2016 Sep;48(3):318-32. doi: 10.1002/uog.15955. Epub 2016 Jun 28.
PubMed 27349699Barra F, Zorzi C, Albanese M, Stepniewska A, Deromemaj X, De Mitri P, Roviglione G, Clarizia R, Gustavino C, Ferrero S, Ceccaroni M. Ultrasonographic Findings Indirectly Predicting Parametrial Involvement in Patients with Deep Endometriosis: The ULTRA-PARAMETRENDO I Study. J Minim Invasive Gynecol. 2023 Jan;30(1):61-72. doi: 10.1016/j.jmig.2022.10.008. Epub 2022 Oct 29.
PubMed 36591808
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Ultrasonographic Findings Predicting Parametrial Involvement in Severe Deep Endometriosis
- ClinicalTrials.gov ID
- NCT05239871
- Acronym / sponsor ID
- ULTRA-PARAMETRENDO I
- Conditions
- Endometriosis, Deep Endometriosis
- Keywords
- Parametrial endometriosis, Deep endometriosis, Transvaginal Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,078 participants (actual)
- Lead sponsor
- Simone FerreroUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 15 Feb 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.
This study evaluated the use of ultrasonographic findings as a first-line imaging tool to raise indirect suspicion of parametrial involvement in women suspected of having severe endometriosis (DE).
Detailed description
Ultrasonographic findings will be conventionally divided in:
- concomitant DE nodules
- indirect DE signs
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with surgical diagnosis of parametrial endometriosis | – | Diagnostic Test: UltrasoundThis cohort will include patients with surgical diagnosis of parametrial endometriosis |
| Women without surgical diagnosis of parametrial endometriosis | – | Diagnostic Test: UltrasoundThis cohort will include patients without surgical diagnosis of parametrial endometriosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with suspected deep endometriosis undergoing surgical approach in a third-level referral center for endometriosis between January 2021 and December 2021
Key inclusion criteria (1 listed)
- patients with suspected deep endometriosis undergoing surgical approach
Key exclusion criteria (3 listed)
- patients with a previous surgical diagnosis of endometriosis
- pazients with radiological evidence of parametrial endometriosis
- patients who could not undergo transvaginal and/or transabdominal ultrasound for any technical reason
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 |
|---|---|---|
| UltrasoundPreoperative transvaginal/transabdominal ultrasonography done according to IDEA criteria. | Diagnostic test | Women with surgical diagnosis of parametrial endometriosis, Women without surgical diagnosis of parametrial endometriosis |
Primary outcome
Number of patients with a surgical diagnosis of parametrial endometriosis
Time frame: At surgery
Number of significant ultrasonographic concomitant DE nodules predicting surgical involvement
Time frame: 1 week before surgical approach
Number of significant ultrasonographic indirect DE signs predicting surgical involvement
Time frame: 1 week before surgical approach
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Results publication: PubMed 34358386Guerriero S, Martinez L, Gomez I, Pascual MA, Ajossa S, Pagliuca M, Alcazar JL. Diagnostic accuracy of transvaginal sonography for detecting parametrial involvement in women with deep endometriosis: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2021 Nov;58(5):669-676. doi: 10.1002/uog.23754.
- Results publication: PubMed 30176361Mabrouk M, Raimondo D, Arena A, Iodice R, Altieri M, Sutherland N, Salucci P, Moro E, Seracchioli R. Parametrial Endometriosis: The Occult Condition that Makes the Hard Harder. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):871-876. doi: 10.1016/j.jmig.2018.08.022. Epub 2018 Aug 31.
- Results publication: PubMed 31518711Ceccaroni M, Clarizia R, Roviglione G. Nerve-sparing Surgery for Deep Infiltrating Endometriosis: Laparoscopic Eradication of Deep Infiltrating Endometriosis with Rectal and Parametrial Resection According to the Negrar Method. J Minim Invasive Gynecol. 2020 Feb;27(2):263-264. doi: 10.1016/j.jmig.2019.09.002. Epub 2019 Sep 10.
- Results publication: PubMed 27349699Guerriero S, Condous G, van den Bosch T, Valentin L, Leone FP, Van Schoubroeck D, Exacoustos C, Installe AJ, Martins WP, Abrao MS, Hudelist G, Bazot M, Alcazar JL, Goncalves MO, Pascual MA, Ajossa S, Savelli L, Dunham R, Reid S, Menakaya U, Bourne T, Ferrero S, Leon M, Bignardi T, Holland T, Jurkovic D, Benacerraf B, Osuga Y, Somigliana E, Timmerman D. Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms, definitions and measurements: a consensus opinion from the International Deep Endometriosis Analysis (IDEA) group. Ultrasound Obstet Gynecol. 2016 Sep;48(3):318-32. doi: 10.1002/uog.15955. Epub 2016 Jun 28.
- Derived from this study: PubMed 36591808Barra F, Zorzi C, Albanese M, Stepniewska A, Deromemaj X, De Mitri P, Roviglione G, Clarizia R, Gustavino C, Ferrero S, Ceccaroni M. Ultrasonographic Findings Indirectly Predicting Parametrial Involvement in Patients with Deep Endometriosis: The ULTRA-PARAMETRENDO I Study. J Minim Invasive Gynecol. 2023 Jan;30(1):61-72. doi: 10.1016/j.jmig.2022.10.008. Epub 2022 Oct 29.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Deep Endometriosis, run by Simone Ferrero 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: finished, as of the sponsor's last update on 2 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a surgical diagnosis of parametrial endometriosis (time frame: At surgery). The study lists 3 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 NCT05239871, which also lists 5 linked publications.
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 2 Nov 2022.