Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Study Overview
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Brief Summary
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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.

Official Title
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Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Multicenter Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata

Conditions
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Condylomata Acuminata

Intervention / Treatment
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* Device: Carbon dioxide Laser ablation
* Device: Electrocoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon dioxide Laser ablation<br>Excision of genital warts using a carbon dioxide laser, ie CO2 Laser | Device: Carbon dioxide Laser ablation<br>* surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage<br>|
| Active Comparator: Electrocoagulation<br>Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation | Device: Electrocoagulation<br>* surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexually transmitted disease, Genital Warts, Venereal Warts