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

NCT ID: NCT04171297

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1866 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2024-05-17

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound evaluation of DE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sydney

OTHER

Sponsor Role collaborator

University of Cagliari

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Timmerman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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Sydney Medical School Nepean

Sydney, , Australia

Site Status

UZLeuven

Leuven, , Belgium

Site Status

University of Cagliari

Cagliari, , Italy

Site Status

Countries

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Australia Belgium Italy

Other Identifiers

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S63056

Identifier Type: -

Identifier Source: org_study_id