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Procedure
Surgical Methods for Vulvar Dysplasia
N/A
Recruiting
Led By Robert W Naumann, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-weeks and 6 months after resection surgery
Awards & highlights
Study Summary
This trial compares two surgical methods to treat vulvar dysplasia: the established "Frozen-Section Directed Excision" and the current "Wide Local Excision".
Who is the study for?
This trial is for adults over 18 with high-grade vulvar dysplasia who can consent, read English/Spanish, and likely have surgery within 90 days. It's not for those who've had pelvic radiation, are on immunosuppressants, or currently receiving cancer treatment.Check my eligibility
What is being tested?
The study compares two surgical methods for treating vulvar dysplasia: 'Frozen-Section Directed Excision' (a dermatology technique) versus the standard 'Wide Local Excision'. The goal is to see which method is more effective.See study design
What are the potential side effects?
While specific side effects aren't listed here, surgical procedures may include risks such as pain at the incision site, bleeding, infection risk post-operation, and potential complications related to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-weeks and 6 months after resection surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-weeks and 6 months after resection surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS
Secondary outcome measures
Blood loss
Narcotic dose required (total during surgery and in recovery)
Post-operative quality of life as determined by the SSQ-8
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Frozen-Section Directed Excision VulvectomyExperimental Treatment1 Intervention
The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.
Group II: Wide Local Excision VulvectomyActive Control1 Intervention
The surgeon(s) will visually identify the abnormal lesion. A Wide Local Excision with 5 mm margins will be made through the dermis per standard of care.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,614 Total Patients Enrolled
Atrium Health Levine Cancer InstituteOTHER
18 Previous Clinical Trials
1,422 Total Patients Enrolled
Robert W Naumann, MDPrincipal InvestigatorWake Forest University Health Sciences
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy in the pelvic area.I am 18 years old or older.My surgery is scheduled within the next 3 months.Surgery isn't possible for me due to the tumor's location near critical areas.I have a confirmed diagnosis of high-grade vaginal pre-cancer and am scheduled for a surgical procedure that aims to remove it with clear margins.I have not taken immunosuppressant medications in the last 30 days.I can read and understand English or Spanish.I am currently receiving treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Wide Local Excision Vulvectomy
- Group 2: Frozen-Section Directed Excision Vulvectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to still enroll in this experiment?
"This clinical trial is not currently enrolling, according to data posted on clinicaltrials.gov; it was initially shared on July 31st 2023 and last modified June 28th 2023. But there are 42 other medical studies actively recruiting patients right now."
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