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

Completed

• Conditions: Endometriosis of Vagina; Endometriosis Rectovaginal Septum; Endometriosis of Bladder; Gynecologic Disease; Endometriosis; Endometriosis, Rectum; Endometriosis of Colon; Surgery

• Registration Number: NCT04171297
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-25
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1866

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Sydney Medical School Nepean; 🇦🇺 Sydney, Australia

University of Cagliari; 🇮🇹 Cagliari, Italy

UZLeuven; 🇧🇪 Leuven, Belgium