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

Surgery Clinical Trial

— IDEA1  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04171297
• Other study ID #: S63056
• Status: Active, not recruiting
• Start date: September 25, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis of Bladder
• Endometriosis of Colon
• Endometriosis of Vagina
• Endometriosis Rectovaginal Septum
• Endometriosis, Rectum
• Genital Diseases, Female
• Gynecologic Disease
• Surgery

Intervention

Procedure:
• Ultrasound evaluation of DE
To evaluate diagnostic accuracy of ultrasound for the presence of deep endometriosis.

Locations

Country	Name	City	State
Australia	Sydney Medical School Nepean	Sydney
Belgium	UZLeuven	Leuven
Italy	University of Cagliari	Cagliari

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	University of Cagliari, University of Sydney

Countries where clinical trial is conducted

Australia,  Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year