A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS
研究概览
简要总结
The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.
详细描述
This is a randomized, single-blinded study. The target population is adults ≥ 18 years of age with histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures. One group of subjects will be assigned to the Frozen-Section Directed Excision surgery arm and will undergo this procedure. The other group of subjects will be assigned to the Wide Local Excision (standard of care) arm and will undergo this procedure. The randomization will be 1:1, meaning for every subject who gets assigned to the Frozen-Section Directed Excision surgery arm, one will also be assigned to the Wide Local Excision arm. There is a 50% chance of getting randomized to either the Frozen-Section Directed Excision procedure or Wide Local Excision. Information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. The study team will also look at recurrence rates (return of the cancer) in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
After randomization, the surgical assignment will be revealed to the attending surgeon. Subjects will remain blinded until the six-month post-operative study visit.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age ≥ 18 years at the time of consent
- •Histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures
- •Surgery is expected to occur within 90 days from randomization
- •Ability to read and understand the English and/or Spanish language
- •As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study
- •No known pregnancy
排除标准
- •Excision is not possible due to anatomy (proximity to urethra/clitoris)
- •Known immunodeficiency syndrome
- •Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/immunosuppressant)
- •History of pelvic region radiation therapy
- •Active anticancer treatment
研究组 & 干预措施
Frozen-Section Directed Excision Vulvectomy
The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.
干预措施: Frozen-Section Directed Excision (Procedure)
Wide Local Excision Vulvectomy
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.
干预措施: Wide Local Excision (Procedure)
结局指标
主要结局
Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS
时间窗: At the time of the resection
Comparison of rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS in subjects who undergo standard of care Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
次要结局
- Narcotic dose required (total during surgery and in recovery)(At the time of the resection and recovery)
- Recovery room time(At the time of the resection and recovery)
- Blood loss(At the time of the resection)
- Wound bed size after surgery(End of resection surgery)
- Recurrence rates at 6 months(6 months post resection surgery)
- Surgical time(At the time of the resection)
- Post-operative quality of life as determined by the SSQ-8(2-weeks and 6 months after resection surgery)
- Primary wound closure rates(2-week post resection surgery)
- Sexual function as determined by the FSFI(Screening and 6 months after resection surgery)