Endometriosis Endometriosis
Conditions
Interventions
 
All women with deep endometriosis in the posterior compartment will undergo additional TVESG at baseline and after 3, 6, and 12 months, that aims to assess tissue stiffness of endometriotic lesions. W
TVESG is a non-invasieve, ultrasound based technique that uses shear wave elastosonography to assess tissue stiffness.  
Sponsors
Máxima MC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: •Premenopausal woman. •Aged = 18 years. •Clinical (suspected) DE. •Planned for TVU and/or MRI for diagnostic evaluation.* Clinical (suspected) DE is based on a patient’s medical history, clinical symptoms, clinical examination, (previous) findings on TVU or MRI and (previous) surgical findings.
Exclusion criteria
Exclusion criteria: Pregnancy. •Known or suspected malignancy (oncological pathology). •Inability to understand written or verbal information in Dutch or English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the reproducibility of the TVESG stiffness measurements at the central region of interest (ROI) of DE lesions in the posterior compartment, expressed in kPa. Intra- and interobserver agreement will be quantified using the ICC (two-way random effects model, absolute agreement). The primary endpoint is achieved if the ICC is =0.60 for both intra- and interobserver agreement, based on two independent observers each performing two repeated measurements during the same consultation, representing at least moderate agreement. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate whether:High lesion stiffness* measured by TVESG is associated with higher pain severity. High lesion stiffness* measured by TVESG is associated with lower overall health-related Quality of Life, and separate domains of the Endometriosis Health Profile-30 (EHP-30). Baseline high lesion stiffness* measured by TVESG is associated with smaller reduction in symptoms after hormonal treatment. High lesion stiffness* measured by TVESG is associated with more histological fibrosis within the endometriosis lesion in patients treated surgically. Higher lesional stiffness measured by TVESG is associated with higher anxiety scores at baseline.High lesion stiffness* measured by TVESG at baseline is associated with smaller reductions in anxiety scores over time during follow-up and treatment.Central lesional stiffness will be higher compared to peripheral lesional stiffness. A learning effect is visible in the ICC of TVESG measurements. *High lesion stiffness defined as centrally ROI measurements = 100 kPa, in accordance to previous research by Ding et al. (2020) (24). | — |
Countries
Netherlands
Contacts
Public ContactM.J.A. Beuken
Máxima MC
Outcome results
None listed