Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Multicenter Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• informed consent
• women with anogenital affection of condyloma acuminata
Locations
Other Locations
Germany
Department of Obstetrics and Gynecology of the Ruhr University Bochum
RECRUITING
Herne
Contact Information
Primary
Ziad Hilal, Dr. med.
z.hilal@zydolab.de
+49231529747
Time Frame
Start Date: 2016-12
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 114
Treatments
Experimental: Carbon dioxide Laser ablation
Excision of genital warts using a carbon dioxide laser, ie CO2 Laser
Active_comparator: Electrocoagulation
Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation
Related Therapeutic Areas
Sponsors
Leads: Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborators: Ruhr University of Bochum