Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Time Taken to Complete Closure
研究概览
简要总结
This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
详细描述
Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with laparoscopic ports over 10mm
排除标准
- •Patients with laparoscopic ports under 10mm
- •Patients who refused the study
- •Patients who received concurrent surgery for other reason
研究组 & 干预措施
EZ Close arm
EZ close used for port-site closure.
干预措施: EZ close (Device)
Carter Thomason arm
Carter Thomason used for port-site closure.
干预措施: Carter Thomason (Device)
结局指标
主要结局
Time Taken to Complete Closure
时间窗: At the time of surgery
The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.
次要结局
- Number of Participants With Visceral Organ Injury(At the time of surgery)
- Number of Participants With Need for Additional Instrument(At the time of surgery)
- Number of Participants With Port-site Hernia(3 days post-op and within one months of surgery)
- Number of Participants With Port-site Infection(3 days post-op and within one months of surgery)
- Number of Participants With Ascitic Fluid Leakage(3 days post-op and within one months of surgery)
- Number of Participants With Wound Dehiscence(3 days post-op and within one months of surgery)
研究者
Hee Youn Kim
Assistant Professor
Saint Vincent's Hospital, Korea