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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage
surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, Germany
RECRUITINGCosmetic result
Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS)
Time frame: 6 weeks
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
Time frame: 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
Time frame: 20 minutes
Postoperative pain
patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery
Time frame: 5 hours
Subjects satisfaction
Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment
Time frame: 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
Time frame: 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)
Time frame: 14 days
Subjects satisfaction
Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment
Time frame: 12 weeks
Cosmetic result
Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)
Time frame: 12 weeks
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