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

Universitaire Ziekenhuizen KU Leuven1,866 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,866

Conditions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (3)

Sydney Medical School Nepean

Sydney, Australia

UZLeuven

Leuven, Belgium

University of Cagliari

Cagliari, Italy

Outcomes

Primary Outcomes

Presence of deep endometriosis

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).

Time frame: 1 year

Data from ClinicalTrials.gov

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