Transanal Decompression Tube Versus Stent as a Bridge to Surgery for Acute Malignant Left-sided Colonic and Rectal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Creation of stoma
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.
详细描述
Approximately 8-47 % of patients with colorectal cancer will present with colonic obstruction. Left-sided colonic and rectal cancer is responsible for nearly 70% of acute colonic obstruction. Emergency colonic surgery for acute obstruction is associated with a higher mortality and morbidity rate than elective surgery. Preoperative decompression results in a less dilated bowel that is more amenable to an elective surgery. Both transanal decompression tube and stent can serve a good preoperative decompression effect and serve a good bridge to surgery. Investigators aim to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite diagnosis of left-side colonic or rectal obstruction;
- •symptomatic colonic obstruction for less than 1 week;
- •colonic obstruction caused by a histologically proven malignant colonic tumor
排除标准
- •suspected benign colonic or rectal obstruction;
- •right-side colonic obstruction;
- •patients with signs of peritonitis;
- •dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease;
- •patients who do not want to undergo surgery.
研究组 & 干预措施
Transanal decompression tube
Patients undergo placement of the transanal decompression tube as a bridge to surgery
干预措施: Transanal decompression tube (Device)
Stent
Patients undergo placement of the stent as a bridge to surgery
干预措施: Stent (Device)
结局指标
主要结局
Creation of stoma
时间窗: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months
Creation of stoma include temporary and definitive stoma.
次要结局
- Surgery-related complications(From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months)
- Transanal decompression tube/stent-related complications(From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days)
- Overall survival(From the date of randomization until the date of death from any cause, assessed up to 24 months)