New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR

Study Overview
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Brief Summary
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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.

Conditions
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CIN, Cervical Cancer

Intervention / Treatment
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* Procedure: conventional cervix biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gentle tissue extraction (curettage)<br>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. | Procedure: conventional cervix biopsy<br>* 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.<br>|
| Active Comparator: conventional cervix biopsy<br>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. | Procedure: conventional cervix biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological comparative results and all cause mobidity | The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less. | 1 year |