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A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394758
First Posted: November 1, 2006
Last Update Posted: November 1, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

Further study details as provided by University Hospitals Cleveland Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394758


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

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
First Submitted: October 30, 2006
First Posted: November 1, 2006
Last Update Posted: November 1, 2006
Last Verified: October 2006

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

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes