A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00394758

Enrollment

150

Registered

2006-11-01

Start date

2000-01-01

Completion date

2005-12-31

Last updated

2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Dysplasia, Vulvar Dysplasia

Keywords

ultrasonic surgical aspiration, CO2 laser surgery, vulvar dysplasia, vaginal dysplasia, recurrence

Brief 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.

Detailed 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: 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.

Interventions

PROCEDURECO2 laser surgery

PROCEDUREultrasonic surgical aspiration

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

* Patients under the age of eighteen or who are pregnant will be excluded

Design outcomes

Primary

Measure	Time frame
recurrence rate	—

Secondary

Measure	Time frame
pain	—
side effects	—
complications	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026