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
- 1
- 主要终点
- Postoperative oedema
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
- •phimosis, stenosis of foreskin, redundant prepuce
排除标准
- •active inflammation of foreskin
研究组 & 干预措施
Circumcision
Adult patients treated with circumcision
干预措施: Circumcision in adults (Procedure)
Circumcision with device
Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
干预措施: Circumcision in adults using sterile single-use circular stapling device (Device)
结局指标
主要结局
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
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
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
Postoperative hematoma
时间窗: First postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
次要结局
- Postoperative oedema(Seventh postoperative day)
- Aesthetic result(Nineteenth postoperative day)
- Postoperative oedema(First postoperative day)
研究者
Vasileios Tzortzis
Professor of Urology
University of Thessaly