跳至主要内容
临床试验/NCT01745991
NCT01745991Unknown不适用

Randomised Control Trial to Investigate the Effectiveness of CoSeal® Surgical Sealant in Reducing Intra-abdominal Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia.

Naved Alizai3 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
126
试验地点
3
主要终点
Severity of Intra-abdominal adhesions

研究概览

简要总结

The investigators plan to invite all children in the UK with biliary atresia, treated at the three national centres (Birmingham, Kings College and Leeds), over a three year period to take part in a randomised control study. The investigators aim to determine the effectiveness of CoSeal® Surgical Sealant (an anti-adhesive agent) in reducing intra-abdominal adhesions (scar tissue) and the morbidity caused by these adhesions in children treated with a Kasai hepatoportoenterostomy. Adhesions are common, if not invariable, after any abdominal surgery. They cause intra-abdominal organs to become stuck to each other and the abdominal wall. This means they are no longer completely free to slide over each other. In particular patients have a lifetime risk that the bowel can become kinked or twisted leading to complications such as bowel obstruction. Adhesions also make repeat abdominal operations more difficult. The adhesions have to be divided in order to separate the organs from each other and the abdominal wall. This can lead to blood loss and increases the risk of damage to these organs. Anti-adhesive agents have been created to reduce the severity of these adhesions, but there is little in the medical literature to evaluate their effectiveness, particularly in children. Biliary atresia is an obliterative obstruction of the bile ducts that occurs in infants. Initially they are treated by an abdominal operation called a Kasai portoenterostomy to restore bile flow from the liver to the intestines. However approximately 40% of these children will go on to require a liver transplant operation in the first two years of life. If CoSeal® Surgical Sealant is effective this could reduce the patients lifetime risk of complications from abdominal adhesions and also facilitate repeat abdominal operations for these children, in particular for those who go on to require a liver transplant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

排除标准

  • Patients with BA and malrotation

结局指标

主要结局

Severity of Intra-abdominal adhesions

时间窗: 5 years

Adhesions assessed at the time of Liver transplantation

次要结局

  • Liver transplantation- blood loss(5 years)
  • Liver Transplantation- Time taken(5 years)

研究者

发起方
Naved Alizai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Naved Alizai

Consultant Paediatric Surgeon

The Leeds Teaching Hospitals NHS Trust

研究点 (3)

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