NCT01448798Unknown不适用
Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Postoperative erectile function
研究概览
简要总结
The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix during athermal nerve-sparing prostate resection compared to conventional hemostasis using electrocautery in patients with localized prostate cancer and to investigate effects on postoperative erectile function and continence.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patient age >18
- •Histologically proven prostate cancer ( Gleason <8; PSA<10ng/ml)
- •Disease confined to prostate in clinical examination
- •Preoperative IEEF-5-Score>20
- •Patient is able to give informed consent
排除标准
- •Prior extensive abdominal surgery
- •Signs for metastatic disease
- •Known allergy against bovine material
- •Patient is unable to give informed consent
结局指标
主要结局
Postoperative erectile function
时间窗: 12 months
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
次要结局
- Postoperative continence(12 months)
- Intraoperative bloodloss(During surgery)
- Intra- and postoperative complications(Perioperative period)
研究者
Axel Haferkamp
Prof. Dr. med. Axel Haferkamp
Johann Wolfgang Goethe University Hospital
研究点 (2)
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