A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

Phase 3

Completed

• Conditions: Vaginal Dysplasia; Vulvar Dysplasia

• Registration Number: NCT00394758
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2005-12-31
• Study Completion: 2005-12-31
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-11-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
recurrence rate

Secondary Outcome Measures

Name	Time	Method
complications
side effects
pain

Trial Locations

Locations (1)

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States