Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adenomyosis. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis: a Prospective Observational Study
Overview
Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity
Detailed description
Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups:
* Uterus affected by adenomyosis (group A): adenomyosis is a gynaecological condition with high prevalence in women of childbearing age and is characterised by the presence of endometrial tissue (innermost layer of the uterus) within the uterine muscle. Adenomyosis can cause abdominal pain and abnormal uterine bleeding. * Uterus affected by fibromatosis (group B): uterine fibromatosis is a gynaecological condition characterised by the appearance of numerous fibroids in the uterus. It is a very frequent condition in the general population and its frequency increases as the age of the patients increases. * Normal uterus (group C). Transvaginal ultrasound, although a reference diagnostic tool, still remains an operator-dependent examination to date: our secondary objective is to build models that can simplify diagnosis through the use of artificial intelligence. The aim is to create various artificial intelligence software that can 'learn to make a diagnosis'. This method has already been applied in radiology, proving capable of discriminating between benign and malignant tumours from images from different diagnostic methods with performance similar to that of experienced radiologists.
Primary outcome measures
- Definition of uterine biometric parameters [Time frame: After enrollment on first visit]
- Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis [Time frame: After enrollment on first visit]
Secondary outcome measures (4)
- Construction of deep learning models on uterine ultrasound images [Time frame: After enrollment on first visit]
- Evaluation of diagnostic accuracy of deep learning validated [Time frame: After enrollment on first visit]
- Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix [Time frame: After enrollment on first visit]
- Evaluation of diagnostic accuracy [Time frame: After enrollment on first visit]
Eligibility criteria
Inclusion criteria
- age between 18 and 60;
- obtaining informed consent
Exclusion criteria
- Hysterectomised patients;
- Virgo patients (hymenal integrity);
- Patients reporting intolerance to transvaginal ultrasound;
- Gynaecological oncology;
- Recent pregnancy or childbirth (within 6 months);
- Menopausal patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06795711 · ADENAS