Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Maxima Medical Center
613 participants
Jul 15, 2022
OBSERVATIONAL
Conditions
Summary
Multicenter prospective cohort study in which patients ≥18 years with an ovarian tumor for which an ultrasound has been performed in accordance with IOTA criteria and the IOTA ADNEX model has been applied are included. Ultrasound data from these patients will be prospectively recorded in a database to determine the diagnostic accuracy of the IOTA ADNEX model in Dutch gynaecological practice.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years
- Presence of a complex ovarian tumor
- Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model
- Understanding of Dutch language
Exclusion Criteria6
- Women with an ovarian tumor that meets the IOTA criteria of a benign easy descriptor:
- Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma
- Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)
- Unilocular tumor with regular walls and maximal diameter \< 10cm (suggestive of simple cyst or cystadenoma)
- Remaining unilocular tumors with regular walls
- Histologically proven malignancy prior to ultrasound
Interventions
From all included patients, prospective data will be collected of the ultrasound(s) performed, the performed treatment and in case of surgery also the final pathological diagnosis. Participating patients will not be subjected to acts or additional procedures or examinations in this study, nor will rules of conduct be imposed.
Locations(1)
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NCT06103916