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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-weeks and 6 months after resection surgery for reporting.

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 more

Awards & 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.

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