CompletedPhase 3

A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

United States150 participantsStarted 2000-01-01

Plain-language summary

1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias 2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician * Pre-operative biopsies to confirm presence of dysplasia / condyloma. Patients with dysplasias of grade 3 / CIS will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy. Exclusion Criteria: * Patients under the age of eighteen or who are pregnant will be excluded

What they're measuring

recurrence rate

Trial details

NCT IDNCT00394758

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-12-31

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