OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
|ClinicalTrials.gov Identifier: NCT01961102|
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment|
|Endometrial Cancer Atypical Hyperplasia||Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section|
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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||March 2016|
Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section
- A negative predictive value of 99 % [ Time Frame: 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%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961102
|Department of Gynaecology, Barmherzige Schwestern|
|Linz, Austria, 4020|