Indirect Markers for Parametrial Involvement in Severe Deep Endometriosis
Sponsor
Simone Ferrero (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05239871
Collaborator
(none)
550
1
3.9
139.5
Study Details
Study Description
Brief Summary
This study evaluated the use of ultrasonographic hard and soft markers as a first-line imaging tool to raise suspicion of parametrial involvement in women suspected of having severe deep endometriosis (DE).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
550 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Hard and Soft Markers Predicting Parametrial Involvement in Severe Deep Endometriosis
Actual Study Start Date
:
Jan 1, 2022
Actual Primary Completion Date
:
Mar 1, 2022
Anticipated Study Completion Date
:
May 1, 2022
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Women with surgical diagnosis of parametrial endometriosis This cohort will include patients with surgical diagnosis of parametrial endometriosis |
Diagnostic Test: Ultrasound
Preoperative transvaginal ultrasonography done according to IDEA criteria.
|
Women without surgical diagnosis of parametrial endometriosis This cohort will include patients without surgical diagnosis of parametrial endometriosis |
Diagnostic Test: Ultrasound
Preoperative transvaginal ultrasonography done according to IDEA criteria.
|
Outcome Measures
Primary Outcome Measures
- Number of patients with a surgical diagnosis of parametrial endometriosis [At surgery]
- Number of significant ultrasonographic hard markers predicting surgical involvement [1 week before surgical approach]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patients with suspected severe endometriosis undergoing surgical approach
Exclusion Criteria:
-
patients with a previous surgical diagnosis of endometriosis
-
pazients with radiological evidence of parametrial endometriosis
-
patients with psychiatric desorders
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
- Simone Ferrero
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Simone Ferrero,
Principal Investigator,
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
ClinicalTrials.gov Identifier:
NCT05239871
Other Study ID Numbers:
- ULTRA-PARAMETRENDO I
First Posted:
Feb 15, 2022
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Simone Ferrero,
Principal Investigator,
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Additional relevant MeSH terms: