Cervical Cancer, CIN
Conditions
Brief summary
It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.
Interventions
PROCEDUREconventional cervix biopsy
Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure. For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions.
Sponsors
Deutsche Klinik fuer Diagnostik
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women between 18 and 80 * Karnofsky-Index of 80 and higher * Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)
Exclusion criteria
* Former malign disease oft he pelvic organs * Pregnancy * Serious internistic diseases * Drug addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological comparative results and all cause mobidity | 1 year | The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less. |
Countries
Germany
Outcome results
None listed