NCT00394758

A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Dysplasia
• Vaginal Dysplasia

Interventions

Type	Name	Description
PROCEDURE	CO2 laser surgery
PROCEDURE	ultrasonic surgical aspiration

Timeline

• Start date: 2000-01-01
• Primary completion: 2005-12-31
• Completion: 2005-12-31
• First posted: 2006-11-01
• Last updated: 2022-05-12

Locations

1 site across 1 country: United States