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OpenTrials
Completed

NCT Number: NCT00394758

A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

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.

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Key information

Conditions

Vulvar Dysplasia Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vaginal Dysplasia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

About this study

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:

  • 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.
  • To compare healing related complications, post-operative pain, and scarring between the two procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 laser surgery

Procedure

ultrasonic surgical aspiration

Procedure

Primary outcomes

  1. recurrence rate

Secondary outcomes

  1. pain

  2. side effects

  3. complications

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Nov 1, 2006
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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