An innovative use of nerve stimulation to prevent the bowel ‘going to sleep’ following colorectal surgery is to be trialled in Leeds.
The condition – known as post-operative ileus – affects 12 per cent of colorectal surgery patients. It can lead to constipation, bloating and vomiting, as well as reduced mobility increased risk of chest infections and blood clots. It is one of the priority unmet clinical needs identified by both the HTC and the Association of Coloproctology of Great Britain and Ireland (ACPGBI).
Trainee surgeon at Leeds Teaching Hospitals Trust and HTC Foundation member, Stephen Chapman, explains: “Although the mechanism behind post-operative ileus is poorly understood, there is some evidence that it is linked to inflammation caused by the operation and handling of the bowel during surgery, which sends the bowel into shock. We want to see if nerve stimulation can reduce the inflammation and help patients recover bowel function quicker.”
The study, led by HTC Clinical Director Professor David Jayne and funded by the Bowel Disease Research Foundation, will investigate stimulation of the vagus nerve. This nerve travels down the neck and through the chest and abdomen, supplying various organs including the intestines. Of key interest to the investigators is the time taken for the bowel to return to normal function and also the levels of various inflammatory makers in the blood.
Patients will use a handheld device, developed by US healthcare company electrocore LLC, to apply an electrical stimulation to the vagus nerve in the neck, easily located by feeling for their pulse. The nerve stimulation will be applied a few days before and after surgery by the patients themselves.
Of 40 colorectal cancer patients recruited for the study, half will use a working device, and half will use a “sham” device. This still gives a perceptible stimulation, but one that is not strong enough to penetrate to the nerve. The technology was developed to treat headaches and migraine, so this is the first time its use will be tested to stimulate bowel function.
A further innovative aspect to the trial will be the use of MRI scans to assess bowel function. While patients will be asked daily about their bowel movements, this only gives a subjective and fairly crude measurement of overall function. The scan – assessed using software developed by co-researcher Dr Alex Menys at University College London – will provide a more accurate and objective measurement to help ensure robust results from the study.
Recruitment will begin over the summer and the researchers hope the trial will be completed within 3-4 months. If successful, funding will be sought for a larger, follow-on study.