NCT06017531

Brief Summary

This is a single-center, prospective diagnostic-accuracy study. All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included. Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. Surgical and pathological data will be analyzed to confirm the presence of parametrial DE.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

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

Study Start

First participant enrolled

March 28, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 24, 2023

Last Update Submit

August 24, 2023

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (7)

  • Diagnostic accuracy

    Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

  • Sensitivity

    Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

  • Specificity

    Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

  • positive predictive value

    of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

  • negative predictive value

    of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

  • Positive likelihood ratio

    Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

  • Negative likelihood ratio

    Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.

    Preoperative exam, surgical and/or histological confirmation

Secondary Outcomes (4)

  • Characteristics of parametrial DE

    Preoperative exam

  • Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium)

    Preoperative exam, surgical and/or histological confirmation

  • Infiltration of parametrial DE nodules

    Preoperative exam, surgical and/or histological confirmation

  • Other DE nodules and indirect DE signs

    Preoperative exam

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included.

You may qualify if:

  • clinical suspicion of DE, for which a preoperative transvaginal ultrasonographic assessment and laparoscopic surgical approach will be indicated;
  • age \> or equal to 18 years
  • informed consent for the participation in the study and for personal data treatment.

You may not qualify if:

  • previous surgical diagnosis of parametrial DE;
  • previous radiological diagnosis of parametrial DE including techniques used to diagnose DE (such as magnetic resonance \[MRI\], computed tomography-based virtual colonoscopy \[CTC\] or double-contrast barium enema);
  • previous bilateral ovariectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

RECRUITING

Related Publications (1)

  • Barra F, Zorzi C, Albanese M, De Mitri P, Stepniewska A, Roviglione G, Giani M, Albertini G, Ferrero S, Ceccaroni M. Ultrasonographic characterization of parametrial endometriosis: a prospective study. Fertil Steril. 2024 Jul;122(1):150-161. doi: 10.1016/j.fertnstert.2024.02.031. Epub 2024 Feb 19.

    PMID: 38382700DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

March 28, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

IT(1)