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

NCT06994091 | Not Yet Recruiting DMC

• 1 other identifier: Z-2024108
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Endometriosis; Surgery; Transvaginal Ultrasound; MRI; Preoperative Planning

Keywords

deep endometriosis; surgery; tranvaginal ultrasound; MRI; preoperative planning

Outcome Measures

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.

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

Study Arms (2)

only transvaginal ultrasound

The TVE subgroup includes patients who underwent preoperative planning using transvaginal elastography (TVE) to assess tissue characteristics prior to Deep Infiltrating Endometriosis (DIE) surgery. This method was used to improve surgical planning by evaluating lesion stiffness and depth, aiding in the assessment of disease extent and potential surgical complexity.

transvaginal ultrasound and MRI

The TVE+MRI subgroup includes patients who underwent preoperative planning using both transvaginal elastography (TVE) and magnetic resonance imaging (MRI) prior to surgery for Deep Infiltrating Endometriosis (DIE). This combined approach aimed to enhance diagnostic accuracy and surgical planning by integrating tissue stiffness assessment from TVE with detailed anatomical visualization from MRI.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Lack of a surgical report that correctly describes all DIE lesions.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• AZ Sint-Jan AV: collaborator
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Study Officials

• Caroline Van Holsbeke

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perrine de Walque

CONTACT

+32495133564; perrinedewalque@hotmail.com

Caroline Van Holsbeke

CONTACT

Study Design

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

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion: August 8, 2025
• Study Completion: December 12, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

BE (1)