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Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

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ClinicalTrials.gov Identifier: NCT02520986
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Ruhr University of Bochum
Information provided by (Responsible Party):
Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : October 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cosmetic result [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment

  8. Cosmetic result [ Time Frame: 12 weeks ]
    Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520986


Contacts
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Contact: Ziad Hilal, Dr. med. +49231529747 z.hilal@zydolab.de

Locations
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Germany
Department of Obstetrics and Gynecology of the Ruhr University Bochum Recruiting
Herne, NRW, Germany, 44625
Contact: Clemens Tempfer, M.D.    02323 499 1801    Clemens.Tempfer@elisabethgruppe.de   
Sponsors and Collaborators
Zydolab - Institute of Cytology and Immune Cytochemistry
Ruhr University of Bochum
Investigators
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Principal Investigator: Ziad Hilal, Dr. med. Zydolab - Institute of Cytology and Immune Cytochemistry

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Responsible Party: Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry
ClinicalTrials.gov Identifier: NCT02520986     History of Changes
Other Study ID Numbers: CONDYLOMA-1
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry:
Sexually transmitted disease
Genital Warts
Venereal Warts

Additional relevant MeSH terms:
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Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases