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临床试验/NCT02012023
NCT02012023已完成不适用

Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
reoperation 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 low anterior resections(LAR). This exploratory study was conducted to evaluate the efficacy and safety of one kind of controllable tube ileostomy(CTI), 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.

In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.

详细描述

After low anterior resection(LAR), 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. The investigators will test the pressure of airbag, and control the pressure of airbag from 30-40cmHg. 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 CTI group, the tube will be removed after 3-4 weeks. If anastomotic leakage occurred, the investigators will test the airbag pressure and keep the pressure during 30-40cmHg. Because with time went on, the ileum will dilated , the airbag pressure will go down, then the feces may go through the airbag plane and flow into colon and the tube ileostomy will lose its defunctioning effect.When the investigators control the airbag pressure, we can control the defunctioning effect of tube stomy. So it is called controllable tube ileostomy. The investigators will keep the tube until the anastomotic leakage was cured.

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 (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
  • •Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure

排除标准

  • •Bowel Preparation is not Satisfied Before Operation
  • •Blood lose is more than 1500ml during operation
  • •Critical incident during operation
  • •The vagina or bladder is seriously damaged and the fix is not satisfied.

研究组 & 干预措施

Controllable tube ileostomy

Experimental

After LAR, the experimental group accepted controllable tube ileostomy.

干预措施: remove the tube ileostomy (Device)

Controllable tube ileostomy

Experimental

After LAR, the experimental group accepted controllable tube ileostomy.

干预措施: Low anterior resection (Device)

Controllable tube ileostomy

Experimental

After LAR, the experimental group accepted controllable tube ileostomy.

干预措施: tube ileostomy (Device)

Loop ileostomy

Active Comparator

After LAR, the experimental group accepted loop ileostomy.

干预措施: loop ileostomy (Device)

Loop ileostomy

Active Comparator

After LAR, the experimental group accepted loop ileostomy.

干预措施: accept reversal operation (Device)

Loop ileostomy

Active Comparator

After LAR, the experimental group accepted loop ileostomy.

干预措施: Low anterior resection (Device)

结局指标

主要结局

reoperation rate

时间窗: about 3 months after operation

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.

mortality

时间窗: about 3 months after operation

anastomotic leakage

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.

次要结局

  • ileus rate(during the follow time(about 6 months after operaion))
  • operation data(durting the operation time (about 1-5 h))

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hua hanju

Doctor

First Affiliated Hospital of Zhejiang University

研究点 (1)

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