Prospective study on the safety and efficacy of a novel laparoscopic trocar with built-in fascial closure function (CLOCAR)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 55
研究概览
简要总结
The first result is to complete the closure of the port site using EZ or CT It was the time it took to The procedure starts when the device starts the port site defined as the first time it was inserted, and the end of the procedure is that the port site Defined as point of time removed from the port site. a stopwatch poem Used to measure liver. Secondary results indicate whether visceral organs were damaged and additional information was added during surgery It was investigated whether the instrument was necessary. Also, wound infection, ten wounds, and mask intestines, multiple fluid leaks 3 days after surgery and 1 week after discharge. Of the 93 patients evaluated for eligibility, 14 were excluded C(8) did not meet the inclusion criteria and 6 refused to participate in the study .) A total of 79 patients were randomly assigned: 40 were EZ Rup, 39 people have been assigned to the CT group. One patient in the EZ group is a patient Follow-up failed because was transferred to the oncology department. Choi In the species analysis, a total of 78 patients (39 patients per group) were analyzed (Fig. 3).
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 19(Year) 至 79(Year)(—)
- 性别
- All
入选标准
- •1) Patients who used laparoscopic ports over 10mm during laparoscopic or robotic surgery
- •2) aged over 18, under 80
- •3) Patients who voluntarily agreed in writing to participate in the trial
排除标准
- •1) Patients who underwent simultaneous operations other than laparoscopic/robotic surgery
- •2) Patients with severe head injury or stroke or a history of the disease
- •3) Patients living in a nursing home or accommodation with poor cognitive ability
- •4) Patients with acute or chronic medical or psychiatric conditions or laboratory abnormalities that are not appropriate for participation in the clinical study
- •5) Patients who are judged to be unappropriate for the clinical study
