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A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

This study has been completed.
Sponsor:
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00394758
First received: October 30, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose
  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.

Condition Intervention Phase
Vulvar Dysplasia
Vaginal Dysplasia
 Procedure: CO2 laser surgery
Procedure: ultrasonic surgical aspiration
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • recurrence rate

Secondary Outcome Measures:
  • pain
  • side effects
  • complications

Estimated Enrollment: 150
Study Start Date: January 2000
Estimated Study Completion Date: December 2005
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394758

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Vivian von Gruenigen, MD University Hospitals of Cleveland
  More Information

No publications provided by University Hospitals of Cleveland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00394758     History of Changes
Other Study ID Numbers: CASE 4804
Study First Received: October 30, 2006
Last Updated: October 30, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
ultrasonic surgical aspiration
CO2 laser surgery
vulvar dysplasia
vaginal dysplasia
recurrence

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013