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NCT Number: NCT02520986

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

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 numerical rating scale (NRS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.

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Key information

Conditions

Condylomata Acuminata Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon dioxide Laser ablation

Device

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

Electrocoagulation

Device

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

Primary outcomes

  1. Cosmetic result

    Time frame: 6 weeks

    Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS)

Secondary outcomes

  1. users satisfaction

    Time frame: 30 minutes

    surgeons will score their satisfaction concerning the used technique by using a 11-step numerical rating scale (NRS) 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 numerical rating scale (NRS) within 5 hours after surgery

  4. Subjects satisfaction

    Time frame: 6 weeks

    Patients will score their Overall satisfaction by using a 11-step numerical rating scale (NRS) 6 weeks after Treatment

  5. Recurrence of genital warts

    Time frame: 12 weeks

    an examination will be performed 12 weeks 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 numerical rating scale (NRS) 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 numerical rating scale (NRS)

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Aug 13, 2015
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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