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

Sponsors

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator: University of Sydney
University of Cagliari

Source Universitaire Ziekenhuizen 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.

Overall Status Recruiting
Start Date September 25, 2019
Completion Date October 2022
Primary Completion Date October 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Presence of deep endometriosis 1 year
Enrollment 1500
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Ultrasound evaluation of DE

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

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dirk Timmerman, MD, PhD Principal Investigator UZ Leuven
Overall Contact

Last Name: Thierry Van den Bosch, MD

Phone: 003216340827

Email: [email protected]

Location
Facility: Status: Contact:
Sydney Medical School Nepean | Sydney, Australia Not yet recruiting George Condous, MD, PhD
UZLeuven | Leuven, 3000, Belgium Recruiting Thierry Van den Bosch, MD
University of Cagliari | Cagliari, Italy Not yet recruiting Stefano Guerriero, MD, PhD
Location Countries

Australia

Belgium

Italy

Verification Date

October 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym IDEA1
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov