Trial Summary

This study aims to recruit 1200 patients from 17 neurosurgical centres across the UK. Any patient who has recently been diagnosed with hydrocephalus and requires the insertion of a ventriculoperitoneal shunt will be approached to take part in the trial. The majority of patients diagnosed with hydrocephalus are usually treated with insertion of a ventriculoperitoneal shunt (VPS). A ventriculoperitoneal shunt is composed of silicone tubing and a valve (see picture 1.0). The tubing passes from the brain fluid cavities (ventricles), under the skin and into the peritoneum (abdominal cavity). The shunt drains cerebrospinal fluid from the ventricles into the peritoneal cavity (see picture 2.)

.  Picture 1.0

 

Picture 2.0

Insertion of a VPS for hydrocephalus is now one of the most common procedures performed in neurosurgical units, and between 3000 and 3500 shunt operations are carried out per year in the UK in adults and children. Sometimes shunts can cause infection in the brain which can lead to serious problems. One of the ways we may be able to reduce infection is by using different types of shunt tubing.

Currently there are three types of shunt tubing available (silicone (not coated), antibiotic coated and silver coated). We don’t know which shunt tubing is the most effective at reducing infection. The only way to find out which of these three types of shunt tubing is the best is to compare all three in adults and children with hydrocephalus. This type of study is called a Randomised Controlled Trial (RCT). The study will help hospitals and doctors decide which type of shunt tubing to use in the future.

You will be allocated to one of the three groups below. To find out if the treatment for one group is better than the other we compare the results from each of the groups. To ensure fairness, we use a computer program to allocate patients to each group. You will have a one in three chance of being allocated to any of the three groups below:

Group A: One third of patients will receive antibiotic coated shunt tubing

Group B: One third of patients will receive silicone (non-coated) shunt tubing

Group C: One third of patients will receive silver coated shunt tubing

All of the shunts used in this trial are licensed for use in adults and children, and are used regularly by doctors. There is no additional risk to trial participants over and above standard care. The risks and benefits have been reviewed by the marketing authority when they provided the licence for these shunts to be used in adults and children. They balanced all the risks and benefits and decided that the potential benefits for using coated shunts outweigh the potential risks. Adverse reactions to the coatings used on shunts have not been reported. There are no direct benefits for you being part of the study compared to people who do not participate, although the information we get from the study may improve the treatment of other people in the future. No additional procedures or visits will be involved over and above standard care. We aim to publish the results of this study in reputable medical literature. Your confidentiality will be ensured at all times and will not be identified in any publication.

Further information on Hydrocephalus and/or VP shunts is available on the following websites:

www.shinecharity.org.uk

www.hydroassoc.org

www.brainandspine.org.uk

www.headway.org.uk

 

 




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