Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

Completed

• Conditions: Adenomyosis; Endometriosis

• Registration Number: NCT04665414
• Lead Sponsor: University Hospital Muenster

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-29
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
specificity MRI	through study completion, an average of 1 year	specificity MRI
sensitivity transvaginal ultrasound	through study completion, an average of 1 year	sensitivity transvaginal ultrasound
specificity transvaginal ultrasound elastography	through study completion, an average of 1 year	specificity transvaginal ultrasound elastography
sensitivity intraoperative ENZIAN FA	through study completion, an average of 1 year	sensitivity intraoperative ENZIAN FA
sensitivity MRI	through study completion, an average of 1 year	sensitivity MRI
specificity transvaginal ultrasound	through study completion, an average of 1 year	specificity transvaginal ultrasound
sensitivity transvaginal ultrasound elastography	through study completion, an average of 1 year	sensitivity transvaginal ultrasound elastography
specificity intraoperative ENZIAN FA	through study completion, an average of 1 year	specificity intraoperative ENZIAN FA

Secondary Outcome Measures

Name	Time	Method
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof	through study completion, an average of 1 year	sensitivity and specificity of single sonographic or MRI criteria or combinations thereof

Trial Locations

Locations (1)

University Hospital Muenster; 🇩🇪 Münster, NRW, Germany