Condylomata Acuminata
Conditions
Keywords
Sexually transmitted disease, Genital Warts, Venereal Warts
Brief summary
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 numerical rating scale (NRS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
Interventions
DEVICECarbon dioxide Laser ablation
surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage - NOTE: pulsed 15 W was never used; the actual setting was 5W continuous
DEVICEElectrocoagulation
surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage
Sponsors
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed consent * women with anogenital affection of condyloma acuminata
Exclusion criteria
* significant language barrier * pregnancy * unwillingness to participate * the use of blood thinner or known coagulation disorder * the use of immunosuppressive medicament * HIV-Infection * malignant diseases * local therapy within 8 weeks before Treatment * wound healing disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic result | 6 weeks | Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| users satisfaction | 30 minutes | surgeons will score their satisfaction concerning the used technique by using a 11-step numerical rating scale (NRS) within 30 minutes after surgery |
| Operation time | 20 minutes | the time from the beginning of the Treatment until the end of the operation (the end of hemostatic interventions) will be measured in minutes |
| Postoperative pain | 5 hours | patients will score their postoperative pain Level using a 11-step numerical rating scale (NRS) within 5 hours after surgery |
| Subjects satisfaction | 6 weeks | Patients will score their Overall satisfaction by using a 11-step numerical rating scale (NRS) 6 weeks after Treatment |
| Recurrence of genital warts | 12 weeks | an examination will be performed 12 weeks after surgery; Recurrence of genital warts will be determined if one or more Areas are infected by genital warts |
| Operative complications | 14 days | Operative complications defined as necessity to intervene surgically up to 14 days postoperatively (number of patients with operative complications and type of complication) |
| Cosmetic result | 12 weeks | Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step numerical rating scale (NRS) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORClemens Tempfer, Dr. med.
Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
Outcome results
None listed