Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Condylomata Acuminata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02520986
• Other study ID #: CONDYLOMA-1
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: Ziad Hilal, Dr. med.
• Phone: +49231529747
• Email: z.hilal[@]zydolab.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Condylomata Acuminata

Intervention

Device:
• Carbon dioxide Laser ablation
surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage
• Electrocoagulation
surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage

Locations

Country	Name	City	State
Germany	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry	Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic result	Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS)	6 weeks
Secondary	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
Secondary	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
Secondary	Postoperative pain	patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery	5 hours
Secondary	Subjects satisfaction	Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment	6 weeks
Secondary	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
Secondary	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
Secondary	Subjects satisfaction	Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment	12 weeks
Secondary	Cosmetic result	Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)	12 weeks