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Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational approach | Other | Wait and see |
|
| Use of Monsel´s Paste | Active Comparator | cervical coagulation using a hemostatic agents, ie monsel´s paste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monsel´s Paste | Procedure | surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss after 15 minutes (5-step visual analogue scale) | blood loss 15 minutes after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale) | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss after 3 hours (5-step visual analogue scale) | blood loss 3 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale) | 3 hours |
| Blood loss after 6 hours (5-step visual analogue scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziad Hilal, M. D. | Zydolab - Institute of Cytology and Immune Cytochemistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zydolab - Institute of Cytology and Immune Cytochemistry | Dortmund | North Rhine-Westphalia | 44137 | Germany | ||
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D014785 | Vision, Ocular |
| ID | Term |
|---|---|
| D055537 | Light Signal Transduction |
| D015398 | Signal Transduction |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
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| Wait and see | Other | finishing examination without hemostatic intervention, awaiting spontaneous coagulation |
|
blood loss 6 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale) |
| 6 hours |
| Blood loss after 24 hours (5-step visual analogue scale) | blood loss 24 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale) | 24 hours |
| Sensation of pain after 15 minutes (10-step visual analogue scale) | patients will score their pain Level using a 10-step visual analogue scale (VAS) 15 minutes after biopsy | 15 minutes |
| Overall Sensation of pain after 24 hours (10-step visual analogue scale) | patients will score their pain Level using a 10-step visual analogue scale (VAS) 24 hours after biopsy | 24 hours |
| Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale) | patients will score their satisfaction Level using a 10-step visual analogue scale (VAS) | 24 hours |
| Department of Obstetrics and Gynecology of the Ruhr University Bochum |
| Herne |
| North Rhine-Westphalia |
| 44625 |
| Germany |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002468 |
| Cell Physiological Phenomena |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009799 | Ocular Physiological Phenomena |