Skip to main content
OpenTrials
Completed

NCT Number: NCT04171297

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gynecologic Disease Endometriosis Endometriosis Rectovaginal Septum Endometriosis of Bladder Endometriosis of Colon Endometriosis of Vagina Endometriosis, Rectum Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Surgery Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Sydney Medical School Nepean, Sydney, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound evaluation of DE

Procedure

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

Primary outcomes

  1. Presence of deep endometriosis

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • University of Cagliari
  • University of Sydney

Registry information

Official study title

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

Acronym: IDEA1

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Nov 20, 2019
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.