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

NCT04171297 | Completed

• 1 other identifier: S63056
• Study Type: observational
• Target: 1,866
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ultrasound evaluation of DE PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with suspected endometriosis scheduled for laparoscopic surgery.

You may qualify if:

• Patients scheduled for radical laparoscopic endometriosis surgery

You may not qualify if:

• \<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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University of Sydney: collaborator
• University of Cagliari: collaborator

Study Sites (3)

Sydney Medical School Nepean

Sydney, Australia

Location

UZLeuven

Leuven, 3000, Belgium

Location

University of Cagliari

Cagliari, Italy

Location

MeSH Terms

Conditions

Genital Diseases, Female; Endometriosis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Dirk Timmerman, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: September 25, 2019
• Primary Completion: December 31, 2023
• Study Completion: May 17, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); IT (1); AU (1)