Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Not Applicable

Recruiting

• Conditions: Condylomata Acuminata
• Interventions: Device: Electrocoagulation; Device: Carbon dioxide Laser ablation

• Registration Number: NCT02520986
• Lead Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Study Start: 2016-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrocoagulation	Electrocoagulation	Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation
Carbon dioxide Laser ablation	Carbon dioxide Laser ablation	Excision of genital warts using a carbon dioxide laser, ie CO2 Laser

Primary Outcome Measures

Name	Time	Method
Cosmetic result	6 weeks	Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
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 visual analogue scale (VAS) within 5 hours after surgery
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)
Subjects satisfaction	12 weeks	Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment
Recurrence of genital warts	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
users satisfaction	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
Cosmetic result	12 weeks	Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology of the Ruhr University Bochum; 🇩🇪 Herne, NRW, Germany