Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02520986
• Collaborator: Ruhr University of Bochum (Other)
• Enrollment: 114
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Condylomata Acuminata	Device: Carbon dioxide Laser ablation; Device: Electrocoagulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Multicenter Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Postoperative pain [5 hours]

   patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery

4. Subjects satisfaction [6 weeks]

   Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment

5. 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

6. 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)

7. Subjects satisfaction [12 weeks]

   Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment

8. Cosmetic result [12 weeks]

   Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW	Germany	44625

Sponsors and Collaborators

• Zydolab - Institute of Cytology and Immune Cytochemistry
• Ruhr University of Bochum

Investigators

• Principal Investigator: Ziad Hilal, Dr. med., Zydolab - Institute of Cytology and Immune Cytochemistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. med. Ziad Hilal, Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry
• ClinicalTrials.gov Identifier: NCT02520986
• Other Study ID Numbers: CONDYLOMA-1
• First Posted: Aug 13, 2015
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. med. Ziad Hilal, Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry: Sexually transmitted disease; Genital Warts; Venereal Warts
• Additional relevant MeSH terms: Condylomata Acuminata

Study Results

No Results Posted as of Jul 22, 2021