Validation of the Adenomyosis Calculator

Completed

• Conditions: Pelvic Pain Syndrome; Adenomyosis

• Registration Number: NCT04135118
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-19
• Study First Posted: 2019-10-22
• Study Start: 2020-01-02
• Primary Completion: 2022-06-23
• Study Completion: 2022-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-23
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the prediction model for adenomyosis	1 year	Diagnostic accuracy will be described using sensitivity (in %), specificity (in %), positive predictive value (in %), negative predictive value (in %), positive likelihood ratio (calculated by sensitivity/1-specificity), negative likelihood ratio (calculated as 1-sensitivity/specificity) and the area under the receiver-operator curve (as calculated with the (0-1) of the model.

Secondary Outcome Measures

Name	Time	Method
Intraclass correlation coefficient (ICC) between readers	2 years	ICC values are categorized as follows: 0-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement; and 0.81-1, almost perfect agreement

Trial Locations

Locations (5)

Turku University Hospital; 🇫🇮 Turku, Finland

Sykehuset i Vestfold; 🇳🇴 Tønsberg, Vestfold, Norway

Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital; 🇳🇴 Oslo, Norway

St. Olavs Hospital, Dept. of Gynecology; 🇳🇴 Trondheim, Trøndelag, Norway

Akershus University Hospital, Dept. of gynecology; 🇳🇴 Lørenskog, Akershus, Norway