A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

May 6, 2022 updated by: University Hospitals Cleveland Medical Center

Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
recurrence rate

Secondary Outcome Measures

Outcome Measure
side effects
pain
complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Vivian von Gruenigen, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2000

Primary Completion (ACTUAL)

December 31, 2005

Study Completion (ACTUAL)

December 31, 2005

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (ESTIMATE)

November 1, 2006

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE 4804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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