OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

Krankenhaus Barmherzige Schwestern Linz

Status: Completed

Conditions: Endometrial Cancer; Atypical Hyperplasia

Treatments: Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section

Study type: Observational

Funder types: Other

Identifiers

NCT01961102

BHS-Gyn1

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Not able to understand and participate in the study
• Premenopausal status
• no informed consent