Brief Title
Validation of the Adenomyosis Calculator
Official Title
Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.
Brief Summary
Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the
uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to
confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of
adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in
diagnosing adenomyosis, but the interpretation of findings requires significant expertise in
ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a
very heterogeneous appearance in ultrasound. There are many different diagnostic signs that
have to be considered and weighed.
In a previous study, the investigators have developed a diagnostic algorithm that helps
clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It
showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and
experience of the examiner. It is now necessary to validate this prediction model in a new,
prospective study so it can be used in clinical practice.
Study Type
Observational
Primary Outcome
Diagnostic accuracy of the prediction model for adenomyosis
Secondary Outcome
Intraclass correlation coefficient (ICC) between readers
Condition
Adenomyosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
500
Start Date
January 2, 2020
Completion Date
December 2022
Primary Completion Date
June 2021
Eligibility Criteria
Inclusion Criteria:
- Premenopausal (defined by having had menstruation the last six month)
- If amenorrhea with levonorgestrel intrauterine device, the woman should be < 45 years
old
- Hysterectomy planned due to a benign condition
- Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3
pieces, given that the orientation of the specimen is still possible for the
pathologist)
- Written consent is given
- Can communicate in Norwegian or English at the Norwegian study sites, and Finnish,
Swedish or English at the Finnish study site.
Exclusion Criteria:
- Gynecological cancer present at the time of inclusion
- Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months
prior to the ultrasound evaluation
- Prior endometrial ablation or resection
- Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea
with levonorgestrel-intrauterine device and age >45 years.
- Need for morcellation of the uterus
Gender
Female
Ages
N/A - 52 Years
Accepts Healthy Volunteers
No
Contacts
Marit Lieng, Phd, +4797793704, [email protected]
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT04135118
Organization ID
OUS P360
Responsible Party
Principal Investigator
Study Sponsor
Oslo University Hospital
Collaborators
The Hospital of Vestfold
Study Sponsor
Marit Lieng, Phd, Principal Investigator, Oslo University Hospital, Oslo, Norway
Verification Date
February 2020