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Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Primary Purpose

Condylomata Acuminata

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Carbon dioxide Laser ablation

Electrocoagulation

About this trial

This is an interventional treatment trial for Condylomata Acuminata focused on measuring Sexually transmitted disease, Genital Warts, Venereal Warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Department of Obstetrics and Gynecology of the Ruhr University BochumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbon dioxide Laser ablation

Electrocoagulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cosmetic result

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

Secondary Outcome Measures

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

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

Postoperative pain

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

Subjects satisfaction

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

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

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)

Subjects satisfaction

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

Cosmetic result

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

Full Information

NCT ID

NCT02520986

First Posted

August 4, 2015

Last Updated

January 24, 2023

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Collaborators

Ruhr University of Bochum

1. Study Identification

Unique Protocol Identification Number

NCT02520986

Brief Title

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Collaborators

Ruhr University of Bochum

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Condylomata Acuminata

Keywords

Sexually transmitted disease, Genital Warts, Venereal Warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carbon dioxide Laser ablation

Arm Type

Experimental

Arm Description

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

Arm Title

Electrocoagulation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Carbon dioxide Laser ablation

Intervention Description

surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage

Intervention Type

Device

Intervention Name(s)

Electrocoagulation

Intervention Description

surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage

Primary Outcome Measure Information:

Title

Cosmetic result

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

users satisfaction

Description

surgeons will score their satisfaction concerning the used technique by using a 11-step visual analogue scale (VAS) within 30 minutes after surgery

Time Frame

30 minutes

Title

Operation time

Description

the time from the beginning of the Treatment until the end of the operation (the end of hemostatic interventions) will be measured in minutes

Time Frame

20 minutes

Title

Postoperative pain

Description

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

Time Frame

5 hours

Title

Subjects satisfaction

Description

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

Time Frame

6 weeks

Title

Recurrence of genital warts

Description

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

Time Frame

12 months

Title

Operative complications

Description

Operative complications defined as necessity to intervene surgically up to 14 days postoperatively (number of patients with operative complications and type of complication)

Time Frame

14 days

Title

Subjects satisfaction

Description

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

Time Frame

12 weeks

Title

Cosmetic result

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ziad Hilal, Dr. med.

Phone

+49231529747

z.hilal@zydolab.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziad Hilal, Dr. med.

Organizational Affiliation

Zydolab - Institute of Cytology and Immune Cytochemistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynecology of the Ruhr University Bochum

City

Herne

State/Province

NRW

ZIP/Postal Code

44625

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clemens Tempfer, M.D.

Phone

02323 499 1801

Clemens.Tempfer@elisabethgruppe.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

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