A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

University Hospitals (UH)

Status and phase

Completed

Phase 3

Conditions

Vulvar Dysplasia

Vaginal Dysplasia

Treatments

Procedure: CO2 laser surgery

Procedure: ultrasonic surgical aspiration

Study type

Interventional

Funder types

Other

Identifiers

NCT00394758

CASE 4804

Details and patient eligibility

About

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

Full description

First line of treatment for vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VAIN) is not well defined. Laser vaporization and ultrasonic surgical aspiration are both accepted surgical modalities used in the treatment of vulvar and vaginal dysplasias, however no prospective study has been done to compare the two procedures. The specific aims of this research study include:

To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias in a prospective, multi-institutional, randomized clinical trial.
To compare healing related complications, post-operative pain, and scarring between the two procedures.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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