Ultrasound Evaluation of the Pelvis in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery

Ultrasound Evaluation of the Pelvis Using the International Deep Endometriosis Analysis (IDEA) Terminology in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery - IDEA 1 Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04171297

Acronym

IDEA1

Enrollment

1866

Registered

2019-11-20

Start date

2019-09-25

Completion date

2024-05-17

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Endometriosis of Bladder, Endometriosis of Colon, Endometriosis of Vagina, Endometriosis Rectovaginal Septum, Endometriosis, Rectum, Gynecologic Disease, Surgery

Brief summary

An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.

Interventions

PROCEDUREUltrasound evaluation of DE

To evaluate diagnostic accuracy of ultrasound for the presence of deep endometriosis.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Patients scheduled for radical laparoscopic endometriosis surgery

Exclusion criteria

* \<18 years * \>45 years * (suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy * Premenarche * Menopause * Pregnancy * Patients refusal for radical surgery (for example refusal for bowel resection/temporary stoma) * Surgery performed more than 1 year after ultrasound scan * Patients refusal to participate to the study

Design outcomes

Primary

Measure	Time frame	Description
Presence of deep endometriosis	1 year	The primary objective is to assess the diagnostic value of the ultrasound features in the diagnosis of deep endometriosis. The endpoints are the univariable diagnostic accuracies of ultrasound features (defined by the IDEA consensus statement) for the presence of deep endometriosis at any location: anterior compartment (i.e. bladder and its specific location) or posterior compartment (i.e. rectovaginal septum, uterosacral ligaments, torus uterinus, vaginal fornix and bowel involvement). All recruited patients are included in this analysis. The reference standard for this objective is whether there is deep endometriosis (at any location) or not (binary outcome).

Countries

Australia, Belgium, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026