A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Radiological anastomotic leaks
研究概览
简要总结
The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.
详细描述
Despite technological advancements, the rate of anastomotic leak after left colon and rectal resection remains high. In most cases, these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes. The device C-REX, developed by CarpoNovum, may help the anastomosis construction, providing at the same time a system to monitor the anastomosis until complete healing. This may lead to reduced anastomotic leak rate and severity. This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial. The objective of the study is to provide preliminary data to determine whether the C-REX device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection, providing new insights on the feasibility and effectiveness of the C-REX device in a real-word setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients ≥ 18 years old, men or women.
- •Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice.
- •Patient indicated to elective minimally invasive sigmoid or high rectal resection.
排除标准
- •Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
- •Patients with preoperative evidence of distal metastasis.
- •Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis.
- •Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.
- •Patients indicated to defunctioning ileostomy (intention to treat).
- •Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.
结局指标
主要结局
Radiological anastomotic leaks
时间窗: 90 days after surgery
Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm
次要结局
- Severity of anastomotic leaks(90 days after surgery)
- Time of anastomosis construction(Intraoperative)
- Postoperative complications(90 days after surgery)
- Positive C-REX integrity tests(Intraoperative)
- Low Anterior Resection Syndrome(90 days after surgery)
- Anastomotic stenosis(90 days after surgery)
- Helathcare costs(90 days after surgery)
- Investigator's satisfaction(Intraoperative)
- Positive leak tests(Intraoperative)