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| Name | Class |
|---|---|
| Ruhr University of Bochum | OTHER |
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In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon dioxide Laser ablation | Experimental | Excision of genital warts using a carbon dioxide laser, ie CO2 Laser |
|
| Electrocoagulation | Active Comparator | Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon dioxide Laser ablation | Device | surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic result | Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| users satisfaction | surgeons will score their satisfaction concerning the used technique by using a 11-step visual analogue scale (VAS) within 30 minutes after surgery | 30 minutes |
| Operation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziad Hilal, Dr. med. | Contact | +49231529747 | z.hilal@zydolab.de |
| Name | Affiliation | Role |
|---|---|---|
| Ziad Hilal, Dr. med. | Zydolab - Institute of Cytology and Immune Cytochemistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology of the Ruhr University Bochum | Recruiting | Herne | North Rhine-Westphalia | 44625 | Germany |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Electrocoagulation | Device | surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage |
|
the time from the beginning of the Treatment until the end of the operation (the end of hemostatic interventions) will be measured in minutes
| 20 minutes |
| Postoperative pain | patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery | 5 hours |
| Subjects satisfaction | Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment | 6 weeks |
| Recurrence of genital warts | an examination will be performed 12 months after surgery; Recurrence of genital warts will be determined if one or more Areas are infected by genital warts | 12 months |
| Operative complications | Operative complications defined as necessity to intervene surgically up to 14 days postoperatively (number of patients with operative complications and type of complication) | 14 days |
| Subjects satisfaction | Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment | 12 weeks |
| Cosmetic result | Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS) | 12 weeks |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |