Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- anastomotic leakage, reoperation and mortality rate
研究概览
简要总结
Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing anterior resections. Although debate about the use of defunctioning stoma continues, meta-analyses and randomized multicenter trial results support the use of defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to evaluate the efficacy and safety of a new diversion method called spontaneously closed cannula ileostomy (SCCI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.
详细描述
After low anterior resection(LAR), in the LI group, the operation method was done as surgeons all known. In the cannula ileostomy group, a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall began to turn pale. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.
In the LI group, patients accepted reversal operation at least 3 months after operation if operation condition permission.
In the cannula ileostomy group, the cannula will be removed after 3-4 weeks. If anastomotic leakage occurred, The investigators will keep the cannula until the anastomotic leakage was cured.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal.
- •Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
- •Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure
排除标准
- •Bowel Preparation is Satisfied Before Operation(This Means That if Surgeons Find That There is Much Feces Left in the Colon,the Patient Will be Excluded)
- •positive air leakage test
- •fractured anastomotic rings
结局指标
主要结局
anastomotic leakage, reoperation and mortality rate
时间窗: about in 3 months after operaion.
Anastomotic leakage(AL) is the main complication after LAR.AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomotic site (including suture and staple lines of the neorectal reservoirs) leading to communication between intra- and extraluminal compartments. When AL occurred, whether this patient need reoperation is determined by the clinical manifestation. Reoperation rate and mortality are two key index to evaluate the effect and safety of cannula ileostomy.
次要结局
- ileus rate(during the follow time(about 6 months after operaion))
研究者
Hua hanju
Doctor
First Affiliated Hospital of Zhejiang University