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Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04665414
Enrollment
103
Registered
2020-12-11
Start date
2017-09-29
Completion date
2021-01-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, Endometriosis

Keywords

adenomyosis, endometriosis, MRI, elastography, ultrasound, hysterectomy

Brief summary

comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards

Interventions

DIAGNOSTIC_TESTMRI

preoperative MRI

DIAGNOSTIC_TESTtransvaginal ultrasound

preoperative transvaginal ultrasound

DIAGNOSTIC_TESTtransvaginal ultrasound elastography

preoperative transvaginal ultrasound elastography

Sponsors

University Hospital Muenster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* dysmenorrhea * dyspareunia * non cyclic lower abdominal pain * hypermenorrhea * menometrorrhaghia * pain while compressing the Uterus during gyn exam * Patient wants to participate * Patient will receive hysterectomy

Exclusion criteria

* Patient declines to participate * contraindications against MRI * contraindications against ultrasound * minor * cannot give informed consent * no hysterectomy planned

Design outcomes

Primary

MeasureTime frameDescription
specificity intraoperative ENZIAN FAthrough study completion, an average of 1 yearspecificity intraoperative ENZIAN FA
sensitivity MRIthrough study completion, an average of 1 yearsensitivity MRI
specificity MRIthrough study completion, an average of 1 yearspecificity MRI
sensitivity transvaginal ultrasoundthrough study completion, an average of 1 yearsensitivity transvaginal ultrasound
specificity transvaginal ultrasoundthrough study completion, an average of 1 yearspecificity transvaginal ultrasound
sensitivity transvaginal ultrasound elastographythrough study completion, an average of 1 yearsensitivity transvaginal ultrasound elastography
specificity transvaginal ultrasound elastographythrough study completion, an average of 1 yearspecificity transvaginal ultrasound elastography
sensitivity intraoperative ENZIAN FAthrough study completion, an average of 1 yearsensitivity intraoperative ENZIAN FA

Secondary

MeasureTime frameDescription
sensitivity and specificity of single sonographic or MRI criteria or combinations thereofthrough study completion, an average of 1 yearsensitivity and specificity of single sonographic or MRI criteria or combinations thereof

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026