Clinical Trial: Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.

Detailed Summary:
Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Current Primary Outcome: Cosmetic result [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• users satisfaction [ Time Frame: 30 minutes ]
  surgeons will score their satisfaction concerning the used technique by using a 11-step visual analogue scale (VAS) within 30 minutes after surgery
• Operation time [ Time Frame: 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 [ Time Frame: 5 hours ]
  patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery
• Subjects satisfaction [ Time Frame: 6 weeks ]
  Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment
• Recurrence of genital warts [ Time Frame: 12 months ]
  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
• Operative complications [ Time Frame: 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)
• Subjects satisfaction [ Time Frame: 12 weeks ]
  Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment
• Cosmetic result [ Time Frame: 12 weeks ]
  Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)

Original Secondary Outcome:

• users satisfaction [ Time Frame: 30 minutes ]
  surgeons will score their satisfaction concerning the used technique by using a 11-step visual analogue scale (VAS) within 30 minutes after surgery
• Operation time [ Time Frame: 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 [ Time Frame: 5 hours ]
  patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery
• Subjects satisfaction [ Time Frame: 6 weeks ]
  Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment
• Recurrence of genital warts [ Time Frame: 12 months ]
  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
• Operative complications [ Time Frame: 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)

Information By: Zydolab - Institute of Cytology and Immune Cytochemistry

Dates:
Date Received: August 4, 2015
Date Started: October 2016
Date Completion: June 2018
Last Updated: October 9, 2016
Last Verified: October 2016