OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
- Conditions
- Atypical HyperplasiaEndometrial Cancer
- Registration Number
- NCT01961102
- Lead Sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Brief Summary
It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.
- Detailed Description
If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.
In case of a hysteroscopical benign result the patient will be informed about the result after the operation.
In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- Postmenopausal status (more than 1 year of last menopausal bleeding)
- Postmenopausal vaginal bleeding
- Asymptomatic postmenopausal endometrial hyperplasia
- Understanding of the german language
- Signature and consent of the patient
- Not able to understand and participate in the study
- Premenopausal status
- no informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A negative predictive value of 99 % Intraoperative To get in combination of hysteroscopy and rapid section of the endometrial curettement a negative predictive value of 99% as well as a positive predictive value of 100%.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Gynaecology, Barmherzige Schwestern
🇦🇹Linz, Austria