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
  • Diagnostic Test: Ultrasound

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

  1. Number of patients with a surgical diagnosis of parametrial endometriosis [At surgery]

  2. 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:

Study Results

No Results Posted as of Mar 15, 2022