Problem addressed, background and strategic significance:
“A fissure in ano” is a split in the skin of the back passage (anal canal). It causes considerable pain when a patient moves their bowels and bleeding. It is common. ‘Acute’ fissures can settle without treatment. ’Chronic’ fissures last longer than 6 weeks, are unlikely to go away without treatment, and are usually referred to hospital.
Glyceryl trinitrate (GTN) ointment is licenced treatment in the community but has side effects (severe headaches). It heals 50% of fissures. Patients referred to hospital are often treated with Diltiazem, which is not available in the community as it has no licence, this also heals 50% of fissures. If these treatments fail patients may require surgery, either injection of Botulinum toxin into the sphincter muscle or part of the sphincter muscle needs to be cut, an operation called a “sphincterotomy”. Clove oil has been used for years to treat toothache, is safe and cheap. It reduces pain and may improve healing, we want to test if it is effective in healing fissure.
We are proposing a study to test if Clove oil is an acceptable treatment for patients with chronic fissures who attend surgical outpatients. We will invite 50 patients to use clove oil for 6 weeks and come back to clinic to find out if they found it acceptable, if they do not wish to participate they will be offered standard care (Diltiazem).
Hoped for results of this research, What this research is expected to add to the knowledge of bowel disease and what is the impact you hope to achieve for patients?
If results of this study are favourable, clove oil could be a cheap, convenient and effective treatment for a common condition where existing treatments are only moderately effective. We would use the data to apply for national funding to test clove oil against other treatments in a UK multicentre study.