Evaluation of the Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in Adult Patients Suffering From Pathologic Foreskin (Phimosis, Stenosis, Redundant Prepuce): A Prospective Randomised Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Bleeding
研究概览
简要总结
Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with pathological foreskin (phimosis, stenosis, redundant prepuce)
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
- None
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Bleeding
时间窗: Intraoperatively
Number of gauzes used intraoperatively
Postoperative hematoma
时间窗: Seventh postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Postoperative oedema
时间窗: Twenty first postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Duration of procedure
时间窗: Intraoperative (Measurement begins at the time of the beginning of the sterilisation of the surgical field and ends at the time of the completion of the bandeage of the wound)
Minutes
次要结局
- Postoperative oedema(Seventh postoperative day)
- Aesthetic result(Nineteenth postoperative day)
研究者
Vasileios Tzortzis
Professor of Urology
University of Thessaly