Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 1 期
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Anastomotic Leakage Rate
研究概览
简要总结
Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal anastomosis easily and less complications, have been produced.The major goal of this study is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in surgery of intestinal anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with age between 18 - 80 years.
- •Patients with operation of end to end anastomosis of colon or small intestine.
- •Patients without previous surgery during 3 months.
- •Patients who understand the nature of this trial and provide informed consent.
排除标准
- •Patients with severe cardiopulmonary disease or other severe disease.
- •Patients who are psychopath, pregnant, and child without capacity for civil conduct.
- •Patients with complete intestinal obstruction.
- •Patients with abdominal cavity infection.
- •Patients who are treating by drug such as adrenal cortical hormone and immune inhibitors, chemotherapy drugs, radiation and so on.
- •Patients who need to accept the anastomosis between rectum and colon.
- •Patients who are required to accept intestinal anastomosis twice or more.
- •Patients who are required to accept the treatment of colostomy.
- •other conditions that render a patient unsuitable for the trial as determined by the study investigators.
结局指标
主要结局
Anastomotic Leakage Rate
时间窗: 7-10 Days
The patients with anastomotic leakage / the total patients. The definition of anastomotic leakage in this study, is included one of the situation as follows: (1) peritonitis caused by leakage, pelvic abscess without radiologically proven anastomotic leakage were considered as equivalents of clinically anastomotic leakage as defined above.; (2) Discharge of faeces, pus or gas from the abdominal drain; (3) All anastomotic leakages were confirmed by one or more of the following methods such as CT scan, ultrasonography and laparotomy.
Anastomotic Hemorrhage Rate
时间窗: 2 Weeks
The patients with anastomotic hemorrhage / the total patients. Anastomotic bleeding was considered gastrointestinal bleeding after surgery, and it ascertains that the bleeding is from anastomosis with endoscopy.
Anastomotic Stenosis Rate
时间窗: 6 Months
The patients with anastomotic stenosis / the total patients.Anastomotic stenosis which is not caused by tumor in the patients with complete or incomplete intestinal obstruction symptoms.
次要结局
- Severe adverse events (SAEs)(6 Months)
- Whether the Biodegradable Stenting Anastomoses be eliminated or not(6 Months)
- Number of participant with abnormal laboratory values(6 Months)
- The time of reconstruction in the surgery of Intestinal Anastomosis(1 Day)
研究者
Zhongtao Zhang
Doctor
Beijing Friendship Hospital