Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ability to recruit patients
研究概览
简要总结
Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.
详细描述
There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes.
As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures.
VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •People requiring inguinal lymphadenectomy i.e.
- •Patients with squamous cell carcinoma or mucosal melanoma of the penis > T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy
- •Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB
- •Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy
- •Small volume palpable inguinal lymph nodes (< 2 cm on CT) not fixed to skin
- •Age > 18 years
排除标准
- •Unfit for surgery
- •People unlikely to benefit from lymphadenectomy because of advanced cancer
- •Those with palpable inguinal lymph nodes fixed to skin or adjacent structures
- •Does not want to participate in the trial or unable to provide informed consent
研究组 & 干预措施
Videoendoscopic Inguinal Lymphadenectomy
Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy
干预措施: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy (Procedure)
Open Inguinal Lymphadenectomy
Removal of inguinal nodes using Open radical inguinal lymphadenectomy
干预措施: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy (Procedure)
结局指标
主要结局
Ability to recruit patients
时间窗: 18 months
Ability to recruit patients at the selected sites (recruitment rate)
次要结局
未报告次要终点