A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-01

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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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:

1. 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.
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

Conditions

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Vulvar Dysplasia Vaginal Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CO2 laser surgery

Intervention Type PROCEDURE

ultrasonic surgical aspiration

Intervention Type PROCEDURE

Eligibility Criteria

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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.