Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status
研究概览
简要总结
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
详细描述
Background:
Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR).
Objective:
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Design, setting and participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •preoperatively planed and intraoperatively performed nerve-sparing approach (at least unilateral)
- •suitable pelvic MRI for the creation of a personalized 3D prostate model,
- •written patient consent
排除标准
- •no nerve sparing performed
结局指标
主要结局
comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status
时间窗: 4 weeks
次要结局
- Erectile function(1 year)
- Oncologic follow-up(1 year)