Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Enrolling

Conditions: Condylomata Acuminata

Treatments: Device: Electrocoagulation; Device: Carbon dioxide Laser ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02520986

CONDYLOMA-1

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Carbon dioxide Laser ablation

Experimental group

Description:

Excision of genital warts using a carbon dioxide laser, ie CO2 Laser

Treatment:

Device: Carbon dioxide Laser ablation

Electrocoagulation

Active Comparator group

Description:

Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation

Treatment:

Device: Electrocoagulation