A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

Vulvar Dysplasia Clinical Trial

Official title:

Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394758
• Other study ID #: CASE 4804
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2000
• Est. completion date: December 31, 2005

Study information

• Verified date: May 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2005
• Est. primary completion date: December 31, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Vaginal Dysplasia
• Vulvar Dysplasia

Intervention

Procedure:
• CO2 laser surgery

• ultrasonic surgical aspiration

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate
Secondary	pain
Secondary	side effects
Secondary	complications