Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

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

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 Overview

• Status: Recruiting
• Conditions: Condylomata Acuminata
• Intervention / Treatment: Device: Carbon dioxide Laser ablation; Device: Electrocoagulation

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziad Hilal, Dr. med.; Phone Number: +49231529747; Email: z.hilal@zydolab.de

Study Locations

• Germany
  • NRW
    • Herne, NRW, Germany, 44625
      • Recruiting
      • Department of Obstetrics and Gynecology of the Ruhr University Bochum
      • Contact: Clemens Tempfer, M.D.; Phone Number: 02323 499 1801; Email: Clemens.Tempfer@elisabethgruppe.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbon dioxide Laser ablation; Excision of genital warts using a carbon dioxide laser, ie CO2 Laser	Device: Carbon dioxide Laser ablation; surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage
Active Comparator: Electrocoagulation; Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation	Device: Electrocoagulation; surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic result	Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	20 minutes
Postoperative pain	patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery	5 hours
Subjects satisfaction	Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment	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	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)	14 days
Subjects satisfaction	Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment	12 weeks
Cosmetic result	Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)	12 weeks

Collaborators and Investigators

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
• Collaborators: Ruhr University of Bochum
• Investigators: Principal Investigator: Ziad Hilal, Dr. med., Zydolab - Institute of Cytology and Immune Cytochemistry

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Genital Warts; Sexually transmitted disease; Venereal Warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Warts; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Condylomata Acuminata
• Other Study ID Numbers: CONDYLOMA-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No