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JOURNAL ONKOLOGIE – STUDIE

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Rekrutierend

NCT-Nummer:
NCT02520986

Studienbeginn:
Dezember 2016

Letztes Update:
26.01.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Condylomata Acuminata

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Zydolab - Institute of Cytology and Immune Cytochemistry

Collaborator:
Ruhr University of Bochum

Studienleiter

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

Kontakt

Studienlocations
(1 von 1)

Department of Obstetrics and Gynecology of the Ruhr University Bochum
44625 Herne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Clemens Tempfer, M.D.
Phone: 02323 499 1801
E-Mail: Clemens.Tempfer@elisabethgruppe.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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)

Studien-Arme

  • Experimental: Carbon dioxide Laser ablation
    Excision of genital warts using a carbon dioxide laser, ie CO2 Laser
  • Active Comparator: Electrocoagulation
    Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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"Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma"

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