Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis
1 other identifier
observational
103
1 country
1
Brief Summary
comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2017
CompletedFirst Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedApril 28, 2021
April 1, 2021
3.3 years
December 4, 2020
April 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
sensitivity MRI
sensitivity MRI
through study completion, an average of 1 year
specificity MRI
specificity MRI
through study completion, an average of 1 year
sensitivity transvaginal ultrasound
sensitivity transvaginal ultrasound
through study completion, an average of 1 year
specificity transvaginal ultrasound
specificity transvaginal ultrasound
through study completion, an average of 1 year
sensitivity transvaginal ultrasound elastography
sensitivity transvaginal ultrasound elastography
through study completion, an average of 1 year
specificity transvaginal ultrasound elastography
specificity transvaginal ultrasound elastography
through study completion, an average of 1 year
sensitivity intraoperative ENZIAN FA
sensitivity intraoperative ENZIAN FA
through study completion, an average of 1 year
specificity intraoperative ENZIAN FA
specificity intraoperative ENZIAN FA
through study completion, an average of 1 year
Secondary Outcomes (1)
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
through study completion, an average of 1 year
Interventions
preoperative MRI
preoperative transvaginal ultrasound
preoperative transvaginal ultrasound elastography
Eligibility Criteria
all patients in accordance with eligibility criteria registered to receive hysterectomy because of a suspicion of adenomyosis according to the above criteria
You may qualify if:
- 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
You may not qualify if:
- Patient declines to participate
- contraindications against MRI
- contraindications against ultrasound
- minor
- cannot give informed consent
- no hysterectomy planned
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
se D Schaefer, MD PhD
University Hospital Muenster, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Gynecology
Study Record Dates
First Submitted
December 4, 2020
First Posted
December 11, 2020
Study Start
September 29, 2017
Primary Completion
January 1, 2021
Study Completion
January 31, 2021
Last Updated
April 28, 2021
Record last verified: 2021-04