Imaging Comparison for the Preoperative Planning and Diagnosis of DIE: a Multicenter Retrospective Study.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorZiekenhuis Oost-Limburg

About this trial

Several centers in Belgium use both transvaginal ultrasound (TVS) and magnetic resonance imaging (MRI) for the preoperative diagnosis of deep infiltrating endometriosis (DIE), while other centers rely almost exclusively on TVS. From the perspective of both the patient and the endometriosis care team, it is not primarily important that every individual lesion is mapped perfectly preoperatively, but rather that all lesions impacting clinical management and surgical planning are accurately detected. This is particularly crucial when a multidisciplinary approach is required, involving a urologist for bladder lesions and/or an abdominal surgeon for invasive rectosigmoid lesions. Moreover, providing the patient with thorough preoperative counseling is essential, and this is, of course, determined by the preoperative findings and the type of planned surgical procedure.

In this study, we first assess the diagnostic performance of TVS in the preoperative diagnosis of DIE. As a secondary objective, we evaluate the added value of MRI compared to TVS for preoperative surgical planning in patients who also underwent an MRI examination.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients who underwent preoperative imaging at AZ Sint-Jan AV and Ziekenhuis Oost-Limburg (ZOL) between October 2021 and December 2024, TVS with or without complementary MR followed by therapeutic surgery as part of DIE.

Disqualifiers

Performing imaging, TVS with or without additional MR, by an operator without specific experience in the field.

Lack of a TVS report diagnosing DIE.

Preoperative diagnosis of only superficial endometriosis and/or endometriomas without DIE.

Performance of surgery by a surgeon without specific experience in the field.

Trial population

All patients who underwent preoperative imaging at AZ Sint-Jan AV and Ziekenhuis Oost-Limburg (ZOL) between October 2021 and December 2024, TVS with or without complementary MR followed by therapeutic surgery as part of DIE.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: only transvaginal ultrasound
Group B: transvaginal ultrasound and MRI

Trial outcomes

Primary outcomes

1

Diagnostic Accuracy of Transvaginal Sonography (TVS) for the preoperative planning of Deep Infiltrating Endometriosis (DIE)

The primary outcome of this study is to assess the diagnostic and preoperative planning performance of transvaginal sonography (TVS) in the preoperative detection of deep infiltrating endometriosis (DIE). TVS findings will be compared with intraoperative observations, classified according to the #ENZIAN system, to determine the sensitivity, specificity, and predictive values of TVS for various lesion locations.

Time frame
From the diagnosis of deep infiltrating endometriosis (DIE) requiring surgical intervention to the surgical procedure itself.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Ziekenhuis Oost-Limburg

Lead sponsor

AZ Sint-Jan AV

Collaborator

Vrije Universiteit Brussel

Collaborator

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