Your session is about to expire
← Back to Search
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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS
Secondary study objectives
Blood loss
Narcotic dose required (total during surgery and in recovery)
Post-operative quality of life as determined by the SSQ-8
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,398 Previous Clinical Trials
2,460,098 Total Patients Enrolled
Atrium Health Levine Cancer InstituteOTHER
26 Previous Clinical Trials
3,551 Total Patients Enrolled
Robert W Naumann, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
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.