Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.
详细描述
In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Not legally competent and/or < 18 years old
- •Not able to comprehend information and/or give written consent
研究组 & 干预措施
Study group
Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique
干预措施: SIA (Procedure)
结局指标
主要结局
Technical success
时间窗: 30 days
Successful construction of anastomosis by double purse-string technique
Complications
时间窗: 30 days
Surgical complications graded by Clavien-Dindo
Mortality
时间窗: 30 days
Postoperative death
次要结局
- Readmissions(30 days)
- Medical complications(30 days)
- Blood loss(30 days)
- Operation time(30 days)
- LOS(90 days)